<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03785431</url>
  </required_header>
  <id_info>
    <org_study_id>KB/169/2016</org_study_id>
    <nct_id>NCT03785431</nct_id>
  </id_info>
  <brief_title>Vascular Healing After Implantation of FANTOM Bioresorbable Scaffold in STEMI: A FANTOM STEMI Study</brief_title>
  <acronym>FANTOM STEMI</acronym>
  <official_title>Vascular Healing Pattern, Vasoreactivity, and Quality of Life in Patients With ST Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention With Sirolimus Eluting FANTOM Bioresorbable Vascular Scaffold With Long Term Clinical, Near Infrared Spectroscopy and Optical Coherence Tomography Follow-up: A FANTOM STEMI Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will assess the safety and performance of the Fantom sirolimus eluting&#xD;
      bioresorbable vascular scaffold (BVS) in the acute setting of myocardial infarction with&#xD;
      unstable lesions and thrombogenic milieu.This is a prospective evaluation of clinical and&#xD;
      patient related measures in STEMI patient who undergo urgent primary percutaneous coronary&#xD;
      intervention (PCI) with stent implantation. Patients with culprit lesions with 2.5 - 3.5 mm&#xD;
      diameter and located in one of the main coronary arteries will be included in the trial and&#xD;
      prospectively observed. The study will comprise 20 patients, who will undergo additional&#xD;
      evaluation with optical coherence tomography (OCT) and near-infrared&#xD;
      spectroscopy/intravascular ultrasound (NIRS/IVUS) at baseline, 6 months, 18-24 months and 36&#xD;
      months. The device will be delivered in sizes 2.5 and 3.0 in diameter / 18 and 24 mm and 3.5&#xD;
      mm x 18 mm in length.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to evaluate the acute safety and feasibility of implantation of the&#xD;
      sirolimus-eluting bioresorbable Fantom scaffold BVS in the setting of ST segment elevation&#xD;
      myocardial infarction (STEMI), as well as the mid and long-term clinical efficacy and healing&#xD;
      pattern of the device, the plaque modification and patient related outcomes, including&#xD;
      quality of life and patient preferences.&#xD;
&#xD;
      Primary end-point&#xD;
&#xD;
        -  Procedural success defined as acute angiographic success (residual stenosis &lt;20% and&#xD;
           Thrombolysis In Myocardial Infarction (TIMI) flow 3) without in-hospital major adverse&#xD;
           cardiac events (MACE) (19) Secondary end-points&#xD;
&#xD;
        -  Angiographic success defined as device implantation into target lesion with residual&#xD;
           stenosis of &lt; 20% and presence of grade 3 TIMI flow assessed by angiography. (19)&#xD;
&#xD;
        -  Quantitative coronary angiographic measurements including minimum lumen diameter (mm),&#xD;
           diameter stenosis (%), late lumen loss (mm), evaluated post-procedure, at 6, 18 and 36&#xD;
           months&#xD;
&#xD;
        -  OCT measurements at patient level including mean lumen area (mm2), mean scaffold area&#xD;
           (mm2), mean vessel area (mm2), mean/min./max. neointima thickness (μm), neointima area&#xD;
           (mm2), scaffold area obstruction (%), symmetry of the neointima thickness, malposed&#xD;
           strut ratio (%), malposed strut total (n), mean malposition distance (mm), malposition&#xD;
           area (mm2) evaluated post-procedure, at 6, 18 and 36 months (16)&#xD;
&#xD;
        -  OCT measurements at scaffold level including mean lumen area (mm2), mean scaffold area&#xD;
           (mm2), mean vessel area (mm2), mean/min./max. neointima thickness (μm), neointima area&#xD;
           (mm2), scaffold area obstruction (%), symmetry of the neointima thickness, malposed&#xD;
           strut ratio (%), malposed strut total (n), mean malposition distance (mm), malposition&#xD;
           area (mm2) evaluated post-procedure, at 12, 24 and 36 months (16)&#xD;
&#xD;
        -  NIRS assessment including: number of blocks/region of interest, block hemogram value,&#xD;
           block hemogram colors [red (p &lt; 0.57), orange (0.57 ≤ p &lt; 0.84), tan (0.84 ≤ p &lt; 0.98)&#xD;
           and yellow (p ≥ 0.98)]. (20)&#xD;
&#xD;
        -  IVUS assessment including: mean lumen area (mm2), mean vessel area (mm2), mean scaffold&#xD;
           area (mm2), mean plaque area (mm2), plaque volume (mm3), calcification volume (mm3),&#xD;
           hyperechogenicity (mm3 and %).&#xD;
&#xD;
        -  Coronary response expressed as percent change from baseline of the acetylcholine- and&#xD;
           nitroglycerine-induced change in mean lumen diameter.&#xD;
&#xD;
        -  Device-oriented composite end-point as defined by Academic Research Consortium,&#xD;
           consisting of cardiac death, myocardial infarction (not clearly attributable to a&#xD;
           non-target vessel), target lesion revascularization at 6, 18 and 36 months. (21)&#xD;
&#xD;
        -  Patient-oriented composite end-point as defined by Academic Research Consortium,&#xD;
           consisting of all-cause mortality, any myocardial infarction (including non-target&#xD;
           vessel territory) and repeat revascularization (includes all target and nontarget&#xD;
           vessel) at 6, 18 and 36 months. (21)&#xD;
&#xD;
        -  Quality of life assessed by generic and specific cardiology psychology tools (QLI,&#xD;
           MacNew, EQ-5D) validated in coronary artery disease patients (especially related to&#xD;
           angina) at 6, 18 and 36 months.&#xD;
&#xD;
      Study design&#xD;
&#xD;
      The study will assess the safety and performance of the Fantom sirolimus eluting BVS in the&#xD;
      acute setting of myocardial infarction with unstable lesions and thrombogenic milieu.&#xD;
&#xD;
      This is a prospective evaluation of clinical and patient related measures in STEMI patient&#xD;
      who undergo urgent primary percutaneous coronary intervention (PCI) with stent implantation.&#xD;
      Patients with culprit lesions with 2.5 - 3.5 mm diameter and located in one of the main&#xD;
      coronary arteries will be included in the trial and prospectively observed. The study will&#xD;
      comprise 20 patients, who will undergo additional evaluation with OCT and NIRS/IVUS at&#xD;
      baseline, 6 months, 18-24 months and 36 months.&#xD;
&#xD;
      The device will be delivered in sizes 2.5 and 3.0 in diameter / 18 and 24 mm and 3.5 mm x 18&#xD;
      mm in length.&#xD;
&#xD;
      Patient population&#xD;
&#xD;
      Total of 20 STEMI patients will be enrolled in this study.&#xD;
&#xD;
      Patient eligibility&#xD;
&#xD;
      The FANTOM STEMI trial will include individuals with confirmed electrocardiographic and&#xD;
      angiographic diagnosis of STEMI, who are eligible for BVS implantation during the primary&#xD;
      PCI. Only patients who sign informed consent and meet all of the inclusion and none of the&#xD;
      exclusion criteria will be enrolled in the study. The final decision regarding inclusion will&#xD;
      be taken after lesion preparation and intravascular imaging assessment.&#xD;
&#xD;
      Inclusion criteria&#xD;
&#xD;
      Candidates must meet ALL of the following inclusion criteria:&#xD;
&#xD;
        -  Electrocardiographic confirmation of acute coronary syndrome with ST segment elevation&#xD;
           (according to the 2012 European Society of Cardiology guidelines for the management of&#xD;
           acute myocardial infarction in patients presenting with ST-segment elevation) or&#xD;
           high-risk non-ST segment elevation patients in whom urgent reperfusion strategy is&#xD;
           applied.&#xD;
&#xD;
        -  Symptom onset to balloon inflation time &lt;12 hours&#xD;
&#xD;
        -  Age &gt;18 years&#xD;
&#xD;
        -  The patient's written informed consent has been obtained prior to the procedure.&#xD;
&#xD;
        -  Each lesion must meet all the following baseline criteria (prior to pre-dilation):&#xD;
&#xD;
             -  De novo lesion in a native coronary artery.&#xD;
&#xD;
             -  Visually estimated stenosis of at least 50%.&#xD;
&#xD;
             -  Visually estimated RVD ≥2.5 mm and ≤3.5 mm (RVD defined as mean of proximal and&#xD;
                distal RVD)&#xD;
&#xD;
             -  Lesion length:&#xD;
&#xD;
                  -  20 mm by visual estimate for single scaffold implantation&#xD;
&#xD;
        -  Each lesion must meet all the following criteria after pre-dilatation:&#xD;
&#xD;
             -  Target vessel reference diameter ≤3.5 mm by visual assessment.&#xD;
&#xD;
             -  Lesion length:&#xD;
&#xD;
                  -  20 mm by visual estimate for single scaffold implantation&#xD;
&#xD;
      Exclusion criteria&#xD;
&#xD;
      Candidates will be excluded from the trial if ANY of the following exclusion criteria are&#xD;
      met:&#xD;
&#xD;
      A. Clinical&#xD;
&#xD;
        -  Cardiogenic shock or pulmonary edema&#xD;
&#xD;
        -  Known hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel,&#xD;
           prasugrel, ticagrelor, heparins, abciximab, everolimus, or polylactide&#xD;
&#xD;
        -  Hypersensitivity to contrast agents&#xD;
&#xD;
        -  Concomitant diseases resulting in significantly worse long-term prognosis&#xD;
&#xD;
        -  Acute and chronic inflammatory conditions&#xD;
&#xD;
        -  Lack of patient consent&#xD;
&#xD;
        -  Acute mechanical complications of myocardial infarction&#xD;
&#xD;
        -  Known pregnancy at time of randomization. Female who is breastfeeding at time of&#xD;
           randomization.&#xD;
&#xD;
        -  Fibrinolysis prior to PCI.&#xD;
&#xD;
        -  Active bleeding or coagulopathy or patient at chronic anticoagulation therapy&#xD;
&#xD;
        -  Life expectancy less then 12 months.&#xD;
&#xD;
        -  Patient has a scheduled surgery or another contraindications that may preclude 12-month&#xD;
           dual antiplatelet therapy.&#xD;
&#xD;
        -  Subject participating in an other trial B. Angiographic&#xD;
&#xD;
        -  Significant left main coronary artery stenosis&#xD;
&#xD;
        -  Multivessel disease requiring coronary artery bypass grafting (MVD scheduled for&#xD;
           percutaneous treatment is not considered as an exclusion criteria).&#xD;
&#xD;
        -  Culprit lesion location within a true bifurcation with a large side branch (vessel lumen&#xD;
           diameter &gt;2.0 mm)&#xD;
&#xD;
        -  Presence of massive calcifications seen within the vessel contour or identified using&#xD;
           intracoronary imaging techniques&#xD;
&#xD;
        -  Lesion within a vein bypass graft&#xD;
&#xD;
        -  Lesions located within 3 mm from vessel origin&#xD;
&#xD;
        -  Target lesion located within previously stented region&#xD;
&#xD;
        -  Anatomic location and lesion morphology precluding an optimal effect of percutaneous&#xD;
           coronary intervention (PCI) or imaging by OCT in the opinion of the investigator&#xD;
&#xD;
        -  Excessive proximal tortuosity&#xD;
&#xD;
        -  Vessel diameter &lt;2.5 mm and &gt; 3.5 mm&#xD;
&#xD;
      Study procedure&#xD;
&#xD;
      Screening procedure&#xD;
&#xD;
      All patient who are admitted to the study site will be evaluated based on this protocol with&#xD;
      intention for study inclusion (patient screening). All patients with STEMI will be considered&#xD;
      as potentially eligible candidates. Before being approach with patient informed consent&#xD;
      (PIC), the member of study team will explain all the risks and benefits associated with the&#xD;
      procedure and allow enough time to the patient for asking any questions that might represent&#xD;
      his/her concerns. The patient must sign the consent prior to enrollment; failure to do so is&#xD;
      a subject for ineligibility. After PIC is acquired, the patient will receive a unique&#xD;
      screening number consisting of three digits (i.e. 001).&#xD;
&#xD;
      The initial evaluation comprises of the following elements:&#xD;
&#xD;
        -  History of symptoms directly leading to the diagnosis&#xD;
&#xD;
        -  Cardiac physical examination&#xD;
&#xD;
        -  12-lead ECG&#xD;
&#xD;
        -  Coronary angiogram.&#xD;
&#xD;
      Thereafter, all inclusion and exclusion criteria will be rechecked. If not all inclusion&#xD;
      criteria are met, or there are at least one-exclusion criteria present the patient will be&#xD;
      considered as screening failure.&#xD;
&#xD;
      Patient allocation&#xD;
&#xD;
      All patient who meet all eligibility criteria after pre-dilatation will be allocated in the&#xD;
      study and have a Fantom BVS implanted.&#xD;
&#xD;
      Medications&#xD;
&#xD;
      Pre-treatment&#xD;
&#xD;
      The pretreatment with aspirin, P2Y12 inhibitor and heparin is allowed as per local practice.&#xD;
      In case the patient did not receive all of the above-mentioned drugs, those will be&#xD;
      administered in latest just after coronary angiogram. The desired doses are: aspirin of 300&#xD;
      mg p.o., P2Y12 inhibitor according to the agent (600 mg of clopidogrel or 60 mg of prasugrel&#xD;
      or 180 mg of ticagrelor), and unfractionated heparin of 70-100 units per kg (or 50-60 units&#xD;
      per kg, if IIb/IIIa inhibitor if co-administered).&#xD;
&#xD;
      Peri-procedural&#xD;
&#xD;
      If no anticoagulant was administered in the pre-hospital setting an intravenous agent should&#xD;
      be given in the cathlab (preferably UFH). If UFH is used, the anticoagulation should be&#xD;
      monitored according to the activated clotting time &gt; 250 second (200-250 seconds if GP&#xD;
      IIb/IIIa inhibitor is being administered). The GP IIb/IIIa inhibitors may be administered at&#xD;
      operator discretion. Before final angiographic projections, the nitroglycerin should be&#xD;
      administered i.c.&#xD;
&#xD;
      Post-procedural&#xD;
&#xD;
      After the procedure patients should be treated according to the European Society of&#xD;
      Cardiology Guidelines for the management of acute myocardial infarction in patients&#xD;
      presenting with ST-segment elevation. Dual antiplatelet therapy (DAPT) must me maintained for&#xD;
      consecutive 12-months after revascularization comprising of low dose aspirin (75-100 mg&#xD;
      daily) and a maintenance dose of P2Y12 inhibitor (clopidogrel 75 mg daily, prasugrel 10 mg&#xD;
      daily, ticagrelor 90 mg bid). In patients with an indication to long-term anticoagulation the&#xD;
      length of DAPT should be adjusted according to individual risk factors.&#xD;
&#xD;
      All patients should receive optimal medical therapy consisting of high dose statins,&#xD;
      additionally in those with low ejection fraction beta-blockers, angiotensin converting enzyme&#xD;
      inhibitors, and aldosterone antagonists should be considered if not contraindicated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 6, 2017</start_date>
  <completion_date type="Anticipated">June 6, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedural success defined as acute angiographic success (residual stenosis &lt;20% and TIMI flow 3) without in-hospital major adverse cardiac events (MACE)</measure>
    <time_frame>From time of procedure until the date of discharge from hospital assessed up to 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Angiographic success defined as device implantation into target lesion with residual stenosis of &lt; 20% and presence of grade 3 TIMI flow assessed by angiography</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative coronary angiographic measurements including minimum lumen diameter (mm), late lumen loss (mm) evaluated post-procedure at 6, 18 and 36 months</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT measurements at patient level evaluated post-procedure, at 6, 18 and 36 months.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative coronary angiographic measurements including diameter stenosis (%) at 6, 18 and 36 months</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>STEMI</condition>
  <condition>Cardiovascular Disease</condition>
  <condition>Bioresorbable Scaffold</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient diagnosed with ST elevation myocardial infarction will undergo bioresorbable stent deployment in culprit lesion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PCI with Phantom Bioresorbable Scaffold</intervention_name>
    <description>Once baseline angiography is performed and all eligibility criteria are met, the patient is included in the study. The target lesion should be crossed with a standard coronary guidewire. Next, the NIRS/IVUS and OCT probe is inserted and a pullback is being performed to evaluate the lesion and vessel morphology. The predilatation with 1:1 non-compliant or semi-compliant balloon is mandatory. Thereafter the scaffold should be inserted and position across the target lesion. Lesions up to 14 mm should be covered with the 18 mm device, for lesions of 15-20 mm a 24 mm device should be used. The scaffold will be deployed with intent to achieve the inner diameter to the reference vessel ration of 1:1 using a single inflation. Post-dilatation using a non-compliant balloon should be performed to achieve complete scaffold apposition and reduce the residual angiographic stenosis below 20%. The final NIRS/IVUS and OCT of the target vessel should be performed.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>OCT and NIRS-IVUS Evaluation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Electrocardiographic confirmation of acute coronary syndrome with ST segment&#xD;
             elevation (according to the 2012 European Society of Cardiology guidelines for the&#xD;
             management of acute myocardial infarction in patients presenting with ST-segment&#xD;
             elevation) or high-risk non-ST segment elevation patients in whom urgent reperfusion&#xD;
             strategy is applied.&#xD;
&#xD;
               -  Symptom onset to balloon inflation time &lt;12 hours&#xD;
&#xD;
               -  Age &gt;18 years&#xD;
&#xD;
               -  The patient's written informed consent has been obtained prior to the procedure.&#xD;
&#xD;
               -  Each lesion must meet all the following baseline criteria (prior to&#xD;
                  pre-dilation):&#xD;
&#xD;
                    -  De novo lesion in a native coronary artery.&#xD;
&#xD;
                    -  Visually estimated stenosis of at least 50%.&#xD;
&#xD;
                    -  Visually estimated RVD ≥2.5 mm and ≤3.5 mm (RVD defined as mean of proximal&#xD;
                       and distal RVD)&#xD;
&#xD;
                    -  Lesion length:&#xD;
&#xD;
                         -  20 mm by visual estimate for single scaffold implantation&#xD;
&#xD;
               -  Each lesion must meet all the following criteria after pre-dilatation:&#xD;
&#xD;
                    -  Target vessel reference diameter ≤3.5 mm by visual assessment.&#xD;
&#xD;
                    -  Lesion length:&#xD;
&#xD;
                         -  20 mm by visual estimate for single scaffold implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Candidates will be excluded from the trial if ANY of the following exclusion criteria are&#xD;
        met:&#xD;
&#xD;
        A. Clinical&#xD;
&#xD;
          -  Cardiogenic shock or pulmonary edema&#xD;
&#xD;
          -  Known hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel,&#xD;
             prasugrel, ticagrelor, heparins, abciximab, everolimus, or polylactide&#xD;
&#xD;
          -  Hypersensitivity to contrast agents&#xD;
&#xD;
          -  Concomitant diseases resulting in significantly worse long-term prognosis&#xD;
&#xD;
          -  Acute and chronic inflammatory conditions&#xD;
&#xD;
          -  Lack of patient consent&#xD;
&#xD;
          -  Acute mechanical complications of myocardial infarction&#xD;
&#xD;
          -  Known pregnancy at time of randomization. Female who is breastfeeding at time of&#xD;
             randomization.&#xD;
&#xD;
          -  Fibrinolysis prior to PCI.&#xD;
&#xD;
          -  Active bleeding or coagulopathy or patient at chronic anticoagulation therapy&#xD;
&#xD;
          -  Life expectancy less then 12 months.&#xD;
&#xD;
          -  Patient has a scheduled surgery or another contraindications that may preclude&#xD;
             12-month dual antiplatelet therapy.&#xD;
&#xD;
          -  Subject participating in an other trial B. Angiographic&#xD;
&#xD;
          -  Significant left main coronary artery stenosis&#xD;
&#xD;
          -  Multivessel disease requiring coronary artery bypass grafting (MVD scheduled for&#xD;
             percutaneous treatment is not considered as an exclusion criteria).&#xD;
&#xD;
          -  Culprit lesion location within a true bifurcation with a large side branch (vessel&#xD;
             lumen diameter &gt;2.0 mm)&#xD;
&#xD;
          -  Presence of massive calcifications seen within the vessel contour or identified using&#xD;
             intracoronary imaging techniques&#xD;
&#xD;
          -  Lesion within a vein bypass graft&#xD;
&#xD;
          -  Lesions located within 3 mm from vessel origin&#xD;
&#xD;
          -  Target lesion located within previously stented region&#xD;
&#xD;
          -  Anatomic location and lesion morphology precluding an optimal effect of percutaneous&#xD;
             coronary intervention (PCI) or imaging by OCT in the opinion of the investigator&#xD;
&#xD;
          -  Excessive proximal tortuosity&#xD;
&#xD;
          -  Vessel diameter &lt;2.5 mm and &gt; 3.5 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lukasz Koltowski, Adjunct. Prof., MD, PhD</last_name>
    <phone>48501418951</phone>
    <email>lukasz@koltowski.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mariusz Tomaniak, MD, PhD</last_name>
    <phone>48501418951</phone>
    <email>mariusz.tomaniak@interia.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>1st Department of Cardiology, Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <zip>02-097</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lukasz Koltowski, MD, PhD</last_name>
      <email>lukasz@koltowski.com</email>
    </contact>
    <contact_backup>
      <last_name>Mariusz Tomaniak, MD</last_name>
      <email>mariusz.tomaniak@interia.pl</email>
    </contact_backup>
    <investigator>
      <last_name>Lukasz Koltowski, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Janusz Kochman, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mariusz Tomaniak, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jakub Maksym, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Łukasz Kołtowski</investigator_full_name>
    <investigator_title>Adjunct Prof., MD, PhD</investigator_title>
  </responsible_party>
  <keyword>STEMI</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>bioresorbable scaffold</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03785431
org study id: KB/169/2016
nct id: NCT03785431
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will assess the safety and performance of the Fantom sirolimus eluting
      bioresorbable vascular scaffold (BVS) in the acute setting of myocardial infarction with
      unstable lesions and thrombogenic milieu.This is a prospective evaluation of clinical and
      patient related measures in STEMI patient who undergo urgent primary percutaneous coronary
      intervention (PCI) with stent implantation. Patients with culprit lesions with 2.5 - 3.5 mm
      diameter and located in one of the main coronary arteries will be included in the trial and
      prospectively observed. The study will comprise 20 patients, who will undergo additional
      evaluation with optical coherence tomography (OCT) and near-infrared
      spectroscopy/intravascular ultrasound (NIRS/IVUS) at baseline, 6 months, 18-24 months and 36
      months. The device will be delivered in sizes 2.5 and 3.0 in diameter / 18 and 24 mm and 3.5
      mm x 18 mm in length.
The aim of the study is to evaluate the acute safety and feasibility of implantation of the
      sirolimus-eluting bioresorbable Fantom scaffold BVS in the setting of ST segment elevation
      myocardial infarction (STEMI), as well as the mid and long-term clinical efficacy and healing
      pattern of the device, the plaque modification and patient related outcomes, including
      quality of life and patient preferences.

      Primary end-point

        -  Procedural success defined as acute angiographic success (residual stenosis <20% and
           Thrombolysis In Myocardial Infarction (TIMI) flow 3) without in-hospital major adverse
           cardiac events (MACE) (19) Secondary end-points

        -  Angiographic success defined as device implantation into target lesion with residual
           stenosis of < 20% and presence of grade 3 TIMI flow assessed by angiography. (19)

        -  Quantitative coronary angiographic measurements including minimum lumen diameter (mm),
           diameter stenosis (%), late lumen loss (mm), evaluated post-procedure, at 6, 18 and 36
           months

        -  OCT measurements at patient level including mean lumen area (mm2), mean scaffold area
           (mm2), mean vessel area (mm2), mean/min./max. neointima thickness (μm), neointima area
           (mm2), scaffold area obstruction (%), symmetry of the neointima thickness, malposed
           strut ratio (%), malposed strut total (n), mean malposition distance (mm), malposition
           area (mm2) evaluated post-procedure, at 6, 18 and 36 months (16)

        -  OCT measurements at scaffold level including mean lumen area (mm2), mean scaffold area
           (mm2), mean vessel area (mm2), mean/min./max. neointima thickness (μm), neointima area
           (mm2), scaffold area obstruction (%), symmetry of the neointima thickness, malposed
           strut ratio (%), malposed strut total (n), mean malposition distance (mm), malposition
           area (mm2) evaluated post-procedure, at 12, 24 and 36 months (16)

        -  NIRS assessment including: number of blocks/region of interest, block hemogram value,
           block hemogram colors [red (p < 0.57), orange (0.57 ≤ p < 0.84), tan (0.84 ≤ p < 0.98)
           and yellow (p ≥ 0.98)]. (20)

        -  IVUS assessment including: mean lumen area (mm2), mean vessel area (mm2), mean scaffold
           area (mm2), mean plaque area (mm2), plaque volume (mm3), calcification volume (mm3),
           hyperechogenicity (mm3 and %).

        -  Coronary response expressed as percent change from baseline of the acetylcholine- and
           nitroglycerine-induced change in mean lumen diameter.

        -  Device-oriented composite end-point as defined by Academic Research Consortium,
           consisting of cardiac death, myocardial infarction (not clearly attributable to a
           non-target vessel), target lesion revascularization at 6, 18 and 36 months. (21)

        -  Patient-oriented composite end-point as defined by Academic Research Consortium,
           consisting of all-cause mortality, any myocardial infarction (including non-target
           vessel territory) and repeat revascularization (includes all target and nontarget
           vessel) at 6, 18 and 36 months. (21)

        -  Quality of life assessed by generic and specific cardiology psychology tools (QLI,
           MacNew, EQ-5D) validated in coronary artery disease patients (especially related to
           angina) at 6, 18 and 36 months.

      Study design

      The study will assess the safety and performance of the Fantom sirolimus eluting BVS in the
      acute setting of myocardial infarction with unstable lesions and thrombogenic milieu.

      This is a prospective evaluation of clinical and patient related measures in STEMI patient
      who undergo urgent primary percutaneous coronary intervention (PCI) with stent implantation.
      Patients with culprit lesions with 2.5 - 3.5 mm diameter and located in one of the main
      coronary arteries will be included in the trial and prospectively observed. The study will
      comprise 20 patients, who will undergo additional evaluation with OCT and NIRS/IVUS at
      baseline, 6 months, 18-24 months and 36 months.

      The device will be delivered in sizes 2.5 and 3.0 in diameter / 18 and 24 mm and 3.5 mm x 18
      mm in length.

      Patient population

      Total of 20 STEMI patients will be enrolled in this study.

      Patient eligibility

      The FANTOM STEMI trial will include individuals with confirmed electrocardiographic and
      angiographic diagnosis of STEMI, who are eligible for BVS implantation during the primary
      PCI. Only patients who sign informed consent and meet all of the inclusion and none of the
      exclusion criteria will be enrolled in the study. The final decision regarding inclusion will
      be taken after lesion preparation and intravascular imaging assessment.

      Inclusion criteria

      Candidates must meet ALL of the following inclusion criteria:

        -  Electrocardiographic confirmation of acute coronary syndrome with ST segment elevation
           (according to the 2012 European Society of Cardiology guidelines for the management of
           acute myocardial infarction in patients presenting with ST-segment elevation) or
           high-risk non-ST segment elevation patients in whom urgent reperfusion strategy is
           applied.

        -  Symptom onset to balloon inflation time <12 hours

        -  Age >18 years

        -  The patient's written informed consent has been obtained prior to the procedure.

        -  Each lesion must meet all the following baseline criteria (prior to pre-dilation):

             -  De novo lesion in a native coronary artery.

             -  Visually estimated stenosis of at least 50%.

             -  Visually estimated RVD ≥2.5 mm and ≤3.5 mm (RVD defined as mean of proximal and
                distal RVD)

             -  Lesion length:

                  -  20 mm by visual estimate for single scaffold implantation

        -  Each lesion must meet all the following criteria after pre-dilatation:

             -  Target vessel reference diameter ≤3.5 mm by visual assessment.

             -  Lesion length:

                  -  20 mm by visual estimate for single scaffold implantation

      Exclusion criteria

      Candidates will be excluded from the trial if ANY of the following exclusion criteria are
      met:

      A. Clinical

        -  Cardiogenic shock or pulmonary edema

        -  Known hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel,
           prasugrel, ticagrelor, heparins, abciximab, everolimus, or polylactide

        -  Hypersensitivity to contrast agents

        -  Concomitant diseases resulting in significantly worse long-term prognosis

        -  Acute and chronic inflammatory conditions

        -  Lack of patient consent

        -  Acute mechanical complications of myocardial infarction

        -  Known pregnancy at time of randomization. Female who is breastfeeding at time of
           randomization.

        -  Fibrinolysis prior to PCI.

        -  Active bleeding or coagulopathy or patient at chronic anticoagulation therapy

        -  Life expectancy less then 12 months.

        -  Patient has a scheduled surgery or another contraindications that may preclude 12-month
           dual antiplatelet therapy.

        -  Subject participating in an other trial B. Angiographic

        -  Significant left main coronary artery stenosis

        -  Multivessel disease requiring coronary artery bypass grafting (MVD scheduled for
           percutaneous treatment is not considered as an exclusion criteria).

        -  Culprit lesion location within a true bifurcation with a large side branch (vessel lumen
           diameter >2.0 mm)

        -  Presence of massive calcifications seen within the vessel contour or identified using
           intracoronary imaging techniques

        -  Lesion within a vein bypass graft

        -  Lesions located within 3 mm from vessel origin

        -  Target lesion located within previously stented region

        -  Anatomic location and lesion morphology precluding an optimal effect of percutaneous
           coronary intervention (PCI) or imaging by OCT in the opinion of the investigator

        -  Excessive proximal tortuosity

        -  Vessel diameter <2.5 mm and > 3.5 mm

      Study procedure

      Screening procedure

      All patient who are admitted to the study site will be evaluated based on this protocol with
      intention for study inclusion (patient screening). All patients with STEMI will be considered
      as potentially eligible candidates. Before being approach with patient informed consent
      (PIC), the member of study team will explain all the risks and benefits associated with the
      procedure and allow enough time to the patient for asking any questions that might represent
      his/her concerns. The patient must sign the consent prior to enrollment; failure to do so is
      a subject for ineligibility. After PIC is acquired, the patient will receive a unique
      screening number consisting of three digits (i.e. 001).

      The initial evaluation comprises of the following elements:

        -  History of symptoms directly leading to the diagnosis

        -  Cardiac physical examination

        -  12-lead ECG

        -  Coronary angiogram.

      Thereafter, all inclusion and exclusion criteria will be rechecked. If not all inclusion
      criteria are met, or there are at least one-exclusion criteria present the patient will be
      considered as screening failure.

      Patient allocation

      All patient who meet all eligibility criteria after pre-dilatation will be allocated in the
      study and have a Fantom BVS implanted.

      Medications

      Pre-treatment

      The pretreatment with aspirin, P2Y12 inhibitor and heparin is allowed as per local practice.
      In case the patient did not receive all of the above-mentioned drugs, those will be
      administered in latest just after coronary angiogram. The desired doses are: aspirin of 300
      mg p.o., P2Y12 inhibitor according to the agent (600 mg of clopidogrel or 60 mg of prasugrel
      or 180 mg of ticagrelor), and unfractionated heparin of 70-100 units per kg (or 50-60 units
      per kg, if IIb/IIIa inhibitor if co-administered).

      Peri-procedural

      If no anticoagulant was administered in the pre-hospital setting an intravenous agent should
      be given in the cathlab (preferably UFH). If UFH is used, the anticoagulation should be
      monitored according to the activated clotting time > 250 second (200-250 seconds if GP
      IIb/IIIa inhibitor is being administered). The GP IIb/IIIa inhibitors may be administered at
      operator discretion. Before final angiographic projections, the nitroglycerin should be
      administered i.c.

      Post-procedural

      After the procedure patients should be treated according to the European Society of
      Cardiology Guidelines for the management of acute myocardial infarction in patients
      presenting with ST-segment elevation. Dual antiplatelet therapy (DAPT) must me maintained for
      consecutive 12-months after revascularization comprising of low dose aspirin (75-100 mg
      daily) and a maintenance dose of P2Y12 inhibitor (clopidogrel 75 mg daily, prasugrel 10 mg
      daily, ticagrelor 90 mg bid). In patients with an indication to long-term anticoagulation the
      length of DAPT should be adjusted according to individual risk factors.

      All patients should receive optimal medical therapy consisting of high dose statins,
      additionally in those with low ejection fraction beta-blockers, angiotensin converting enzyme
      inhibitors, and aldosterone antagonists should be considered if not contraindicated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Procedural success defined as acute angiographic success (residual stenosis <20% and TIMI flow 3) without in-hospital major adverse cardiac events (MACE)
time frame: From time of procedure until the date of discharge from hospital assessed up to 30 days
measure: Angiographic success defined as device implantation into target lesion with residual stenosis of < 20% and presence of grade 3 TIMI flow assessed by angiography
time frame: 3 years
measure: Quantitative coronary angiographic measurements including minimum lumen diameter (mm), late lumen loss (mm) evaluated post-procedure at 6, 18 and 36 months
time frame: 3 years
measure: OCT measurements at patient level evaluated post-procedure, at 6, 18 and 36 months.
time frame: 3 years
measure: Quantitative coronary angiographic measurements including diameter stenosis (%) at 6, 18 and 36 months
time frame: 3 years
arm group label: Intervention
arm group type: Experimental
description: Patient diagnosed with ST elevation myocardial infarction will undergo bioresorbable stent deployment in culprit lesion.
intervention type: Device
intervention name: PCI with Phantom Bioresorbable Scaffold
description: Once baseline angiography is performed and all eligibility criteria are met, the patient is included in the study. The target lesion should be crossed with a standard coronary guidewire. Next, the NIRS/IVUS and OCT probe is inserted and a pullback is being performed to evaluate the lesion and vessel morphology. The predilatation with 1:1 non-compliant or semi-compliant balloon is mandatory. Thereafter the scaffold should be inserted and position across the target lesion. Lesions up to 14 mm should be covered with the 18 mm device, for lesions of 15-20 mm a 24 mm device should be used. The scaffold will be deployed with intent to achieve the inner diameter to the reference vessel ration of 1:1 using a single inflation. Post-dilatation using a non-compliant balloon should be performed to achieve complete scaffold apposition and reduce the residual angiographic stenosis below 20%. The final NIRS/IVUS and OCT of the target vessel should be performed.
arm group label: Intervention
other name: OCT and NIRS-IVUS Evaluation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lukasz Koltowski, Adjunct. Prof., MD, PhD
phone: 48501418951
email: lukasz@koltowski.com
last name: Mariusz Tomaniak, MD, PhD
phone: 48501418951
email: mariusz.tomaniak@interia.pl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Łukasz Kołtowski
investigator title: Adjunct Prof., MD, PhD
mesh term: Cardiovascular Diseases
mesh term: ST Elevation Myocardial Infarction
sharing ipd: Undecided