<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/NCT01724957</url>
  </required_header>
  <id_info>
    <org_study_id>20120109-05</org_study_id>
    <nct_id>NCT01724957</nct_id>
  </id_info>
  <brief_title>FFR vs. icECG in Coronary Bifurcations</brief_title>
  <acronym>FIESTA</acronym>
  <official_title>Fractional Flow Reserve Versus Intracoronary ECG for Detection of Post Stenting Ischemia in Side Branch Territory in coronAry Bifurcation Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University National Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University National Heart Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict&#xD;
      significance of SB ostial stenosis after main vessel stenting in coronary bifurcation&#xD;
      lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The coronary bifurcation lesions pose a therapeutic problem with high rates of periprocedural&#xD;
      complications, higher rates of in-stent restenosis and stent thrombosis. These are lesions&#xD;
      where stenting is not superior in comparison to balloon angioplasty in regard to side branch.&#xD;
      It was demonstrated many times, in literature and in daily practice, that angiographically&#xD;
      high grade ostial side branch stenosis is not flow limiting and do not cause ischemia,&#xD;
      therefore do not require treatment. From the other side, our own data with MRI before and&#xD;
      after bifurcation PCI demonstrated that occurrence of angiographic stenosis more than 70% in&#xD;
      diameter is associated with periprocedural myonecrosis in the region of side branch. This&#xD;
      fact puts a very important question about the mechanisms of this myonecrosis. If the jailed&#xD;
      side branch has no significant flow limiting stenosis, but there is some degree of residual&#xD;
      ischemia, which after some period of persistence could lead to myonecrosis, will mean that&#xD;
      more aggressive treatment of ostial stenosis is needed. It is interesting that the strategy&#xD;
      of treatment is very important, because techniques with second stent implantation (with&#xD;
      primary purpose to limit SB ischemia) are associated with higher grade of troponin increase.&#xD;
      Of course this is association and not causality, despite that in randomized study (NORDIC I)&#xD;
      it was confirmed also.&#xD;
&#xD;
      It is without explanation the fact of rare occurrence of significant (flow limiting, FFR&#xD;
      &lt;.75) stenosis appearance (less than 40% in side branches with ostial stenosis more than 75%)&#xD;
      and almost 50% periprocedural myonecrosis detected in the side branch areas. One working&#xD;
      hypothesis is that stent implantation and related episode of ischemia induces prolonged&#xD;
      vasospasm, resulting in prolonged ischemia. Thus, the ostial stenosis could be&#xD;
      non-significant as estimated and registered by FFR, but on microcirculatory lever ischemia&#xD;
      could persist is small areas for which available flow is not sufficient despite that global&#xD;
      regional flow is deemed sufficient. It is also possible that those patients have not enough&#xD;
      recruitable collaterals. It is also possible that both factors act together.&#xD;
&#xD;
      Although FFR is useful for assessing the degree of ischemia caused by a coronary lesion, it&#xD;
      cannot give information as to whether this ischemia may be clinically significant or not,&#xD;
      i.e. whether the ischemia affects a large territory. Therefore, it can be implicated that FFR&#xD;
      may not be useful in predicting clinically meaningful ischemia in a specific side branch&#xD;
      vessel.&#xD;
&#xD;
      The intracoronary electrocardiography (i.c. ECG) is a very sensitive method for ischemia&#xD;
      detection. The i.c. ECG reacts earlier on ischemia; the changes are much more prominent and&#xD;
      easy to register. The wire tip could be positioned directly in different regions and thus to&#xD;
      &quot;map&quot; regional ischemia. In most of the studies and from our own observations became evident&#xD;
      that when surface ECG do not react the i.c. ECG demonstrates significant changes in&#xD;
      ST-segment and QRS complex. Moreover, the registration of i.c. ECG is very cheap and needs&#xD;
      only an adapter connecting coronary wire end and ECG. An i.c. ECG also can differentiate&#xD;
      residual ischemic changes in distal main vessel and side branch as sources of prolonged&#xD;
      ischemia, respectively - source of periprocedural myonecrosis.&#xD;
&#xD;
      The objective of this study is to evaluate concordance between icECG findings and FFR&#xD;
      findings after stenting main vessel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Side branch region ischemia duration</measure>
    <time_frame>Percutaneous coronary intervention procedure time (up to 4h)</time_frame>
    <description>FFR&lt;0.80 at the SB ostium after stenting main vessel in coronary bifurcation lesion; icECG ST-segment elevation &gt;2.0mm; T-wave inversion &gt;3mm; ST-segment depression &gt;2mm, not observed at the beginning of procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>12 months</time_frame>
    <description>Any revascularization at the territory of previously implanted stent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients not alive</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction after hospital discharge</measure>
    <time_frame>12 months</time_frame>
    <description>MI according to universal definition of MI - CK-MB &gt; 2xULN +/- symptoms +/- surface ECG changes in at least 2 leads</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset angina or heart failure symptoms</measure>
    <time_frame>12 months</time_frame>
    <description>New onset angina symptoms of at least CCS class II; New onset dyspnea at exertion or at rest</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Periprocedural myonecrosis - extent of post PCI enzyme elevation</measure>
    <time_frame>48h</time_frame>
    <description>Troponin I elevation 1-3; 3-5; &gt;5 x ULN Creatin phospho kinase MB fraction elevation 1-3; 3-5; &gt;5 x ULN</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Patients with coronary bifurcation lesions</arm_group_label>
    <description>Only one group will be studied. The patient will be a slef-reference.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intracoronary ECG</intervention_name>
    <description>Recording of icECG from the tip of PCI guidewire. The wire end is connected through alligator clips to V-lead from surface ECG</description>
    <arm_group_label>Patients with coronary bifurcation lesions</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Significant, &gt;50% diameter stenosis artery scheduled for stent insertion at the main&#xD;
             vessel (Medina types: 1xx, x1x, 11x);&#xD;
&#xD;
          -  Side branch vessel at least 2.0mm&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject at least 18 years of age.&#xD;
&#xD;
          -  Subject able to verbally confirm understandings of risks, benefits of receiving PCI&#xD;
             for true bifurcation lesions, and he/she or his/her legally authorized representative&#xD;
             provides written informed consent prior to any study related procedure.&#xD;
&#xD;
          -  Target main branch lesion(s) located in a native coronary artery with diameter of ≥&#xD;
             2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery&#xD;
             with diameter of ≥ 2.0 mm.&#xD;
&#xD;
          -  Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with significant ST-T change (≥ 1mm).&#xD;
&#xD;
          -  Non-cardiac co-morbid conditions are present with life expectancy &lt;1 year or that may&#xD;
             result in protocol non-compliance (per site investigator's medical judgment).&#xD;
&#xD;
          -  Subjects who refuse to give informed consent.&#xD;
&#xD;
          -  Subjects with the following angiographic characteristics: left main coronary artery&#xD;
             stenosis, total occlusion before occurrence of SB, lesion of interest located at&#xD;
             infarct-related artery.&#xD;
&#xD;
          -  Subjects with LVEF &lt; 30%.&#xD;
&#xD;
          -  Subjects with moderate or severe degree valvular heart disease or primary&#xD;
             cardiomyopathy.&#xD;
&#xD;
          -  LBBB, RBBB, atrial fibrillation/flutter with no identifiable isoelectric line.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dobrin Vassilev, MD, PhD</last_name>
    <phone>00359886846550</phone>
    <email>dobrinv@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Indiana-Purdue University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>IN 46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Heart Hospital</name>
      <address>
        <city>Sofia</city>
        <zip>1309</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dobrin Vassilev, MD, PhD</last_name>
      <phone>00359886846550</phone>
      <email>dobrinv@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>August 18, 2019</last_update_submitted>
  <last_update_submitted_qc>August 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University National Heart Hospital</investigator_affiliation>
    <investigator_full_name>Dobrin Vassilev</investigator_full_name>
    <investigator_title>Dobrin Vassilev MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Fractional flow reserve,</keyword>
  <keyword>coronary bifurcation stenosis,</keyword>
  <keyword>intracoronary ECG,</keyword>
  <keyword>coronary stent</keyword>
  <keyword>Coronary bifurcation lesions</keyword>
  <keyword>icECG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01724957
org study id: 20120109-05
nct id: NCT01724957
lead sponsor: 
has dmc: Yes
The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict
      significance of SB ostial stenosis after main vessel stenting in coronary bifurcation
      lesions.
The coronary bifurcation lesions pose a therapeutic problem with high rates of periprocedural
      complications, higher rates of in-stent restenosis and stent thrombosis. These are lesions
      where stenting is not superior in comparison to balloon angioplasty in regard to side branch.
      It was demonstrated many times, in literature and in daily practice, that angiographically
      high grade ostial side branch stenosis is not flow limiting and do not cause ischemia,
      therefore do not require treatment. From the other side, our own data with MRI before and
      after bifurcation PCI demonstrated that occurrence of angiographic stenosis more than 70% in
      diameter is associated with periprocedural myonecrosis in the region of side branch. This
      fact puts a very important question about the mechanisms of this myonecrosis. If the jailed
      side branch has no significant flow limiting stenosis, but there is some degree of residual
      ischemia, which after some period of persistence could lead to myonecrosis, will mean that
      more aggressive treatment of ostial stenosis is needed. It is interesting that the strategy
      of treatment is very important, because techniques with second stent implantation (with
      primary purpose to limit SB ischemia) are associated with higher grade of troponin increase.
      Of course this is association and not causality, despite that in randomized study (NORDIC I)
      it was confirmed also.

      It is without explanation the fact of rare occurrence of significant (flow limiting, FFR
      <.75) stenosis appearance (less than 40% in side branches with ostial stenosis more than 75%)
      and almost 50% periprocedural myonecrosis detected in the side branch areas. One working
      hypothesis is that stent implantation and related episode of ischemia induces prolonged
      vasospasm, resulting in prolonged ischemia. Thus, the ostial stenosis could be
      non-significant as estimated and registered by FFR, but on microcirculatory lever ischemia
      could persist is small areas for which available flow is not sufficient despite that global
      regional flow is deemed sufficient. It is also possible that those patients have not enough
      recruitable collaterals. It is also possible that both factors act together.

      Although FFR is useful for assessing the degree of ischemia caused by a coronary lesion, it
      cannot give information as to whether this ischemia may be clinically significant or not,
      i.e. whether the ischemia affects a large territory. Therefore, it can be implicated that FFR
      may not be useful in predicting clinically meaningful ischemia in a specific side branch
      vessel.

      The intracoronary electrocardiography (i.c. ECG) is a very sensitive method for ischemia
      detection. The i.c. ECG reacts earlier on ischemia; the changes are much more prominent and
      easy to register. The wire tip could be positioned directly in different regions and thus to
      "map" regional ischemia. In most of the studies and from our own observations became evident
      that when surface ECG do not react the i.c. ECG demonstrates significant changes in
      ST-segment and QRS complex. Moreover, the registration of i.c. ECG is very cheap and needs
      only an adapter connecting coronary wire end and ECG. An i.c. ECG also can differentiate
      residual ischemic changes in distal main vessel and side branch as sources of prolonged
      ischemia, respectively - source of periprocedural myonecrosis.

      The objective of this study is to evaluate concordance between icECG findings and FFR
      findings after stenting main vessel.
observational model: Cohort
time perspective: Prospective
measure: Side branch region ischemia duration
time frame: Percutaneous coronary intervention procedure time (up to 4h)
description: FFR<0.80 at the SB ostium after stenting main vessel in coronary bifurcation lesion; icECG ST-segment elevation >2.0mm; T-wave inversion >3mm; ST-segment depression >2mm, not observed at the beginning of procedure
measure: Target lesion revascularization
time frame: 12 months
description: Any revascularization at the territory of previously implanted stent.
measure: Number of patients not alive
time frame: 12 month
measure: Myocardial infarction after hospital discharge
time frame: 12 months
description: MI according to universal definition of MI - CK-MB > 2xULN +/- symptoms +/- surface ECG changes in at least 2 leads
measure: New onset angina or heart failure symptoms
time frame: 12 months
description: New onset angina symptoms of at least CCS class II; New onset dyspnea at exertion or at rest
measure: Periprocedural myonecrosis - extent of post PCI enzyme elevation
time frame: 48h
description: Troponin I elevation 1-3; 3-5; >5 x ULN Creatin phospho kinase MB fraction elevation 1-3; 3-5; >5 x ULN
arm group label: Patients with coronary bifurcation lesions
description: Only one group will be studied. The patient will be a slef-reference.
intervention type: Procedure
intervention name: Intracoronary ECG
description: Recording of icECG from the tip of PCI guidewire. The wire end is connected through alligator clips to V-lead from surface ECG
arm group label: Patients with coronary bifurcation lesions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Dobrin Vassilev, MD, PhD
phone: 00359886846550
email: dobrinv@gmail.com
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
country: Bulgaria
country: United States
responsible party type: Principal Investigator
investigator affiliation: University National Heart Hospital
investigator full name: Dobrin Vassilev
investigator title: Dobrin Vassilev MD, PhD
mesh term: Coronary Artery Disease