<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/NCT02212626</url>
  </required_header>
  <id_info>
    <org_study_id>FMRP-130326</org_study_id>
    <nct_id>NCT02212626</nct_id>
  </id_info>
  <brief_title>Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Rotarex Belgium In-stent Occlusion</brief_title>
  <acronym>ROBINSON</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Flanders Medical Research Program</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Flanders Medical Research Program</source>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and efficacy of recanalization of acute&#xD;
      and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub Medical)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of acute and subacute thromboembolic and local thrombotic ischemic lesions of&#xD;
      the ilaco-popliteal segments in the lower extremities has undergone considerable changes over&#xD;
      recent years. The standard modality of surgical thrombectomy with the Fogarty balloon&#xD;
      catheter technique for acute arterial occlusions has been replaced by percutaneous catheter&#xD;
      techniques, i.e. percutaneous aspiration thrombectomy (PAT) for thrombus aspiration.&#xD;
      Alternatively, catheter-directed pharmacologic thrombolytic therapy with or without&#xD;
      additional catheter aspiration is used, particularly if the occlusion is already a few days&#xD;
      or weeks old. These techniques obtain the best results in acute occlusions of less than 2&#xD;
      weeks' duration.&#xD;
&#xD;
      Both techniques have limitations such as the application of fibrinolytic substances and&#xD;
      technical, impossibility of rapid and complete thrombus extraction. Therefore various&#xD;
      mechanical devices have been introduced which involve maceration or fragmentation and removal&#xD;
      of thrombus. The two categories of devices for mechanical thrombectomy (MT) are: (1)&#xD;
      rotational recirculation devices which work by the vortex principle, such as the Amplatz&#xD;
      thrombectomy catheter (ATD, Microvena, White Bear Lake, MN) or the Arrow-Trerotola PTD (Arrow&#xD;
      International, Reading, PA); and (2) hydrodynamic (rheolytic) recirculation devices which&#xD;
      operate on the principle of the Venturi effect, such as the Hydrolyser (Cordis, Johnson and&#xD;
      Johnson, Miami, FL), Oasis (Boston Scientific, Galway, Ireland), and the Angiojet (RTC;&#xD;
      Possis Medical, Minneapolis, MN) [5-10]. These devices are not suited for subacute occlusions&#xD;
      of more than 7-14 days' duration. Recently, a new rotational mechanical thrombectomy&#xD;
      catheter, the Straub Rotarex / Aspirex (Straub Medical, 7323 Wangs, Switzerland) has been&#xD;
      introduced. This device combines the two essential effects of mechanical clot fragmentation&#xD;
      and removal of the fragmented clot material from the vessel by negative pressure. Two studies&#xD;
      using the Rotarex system with 38, resp. 98 patients showed a primary patency rate of 62%,&#xD;
      resp. 54% at 6 months and described the Rotarex / Aspirex systems as an efficient and quick&#xD;
      technique for revascularization of acute femoropopliteal de novo occlusions. A more recent&#xD;
      publication dating from 2011 reports results from using Rotarex® catheters for treatment of&#xD;
      in-stent reocclusions of femoropopliteal arteries. In 78 patients, the restenosis rate was&#xD;
      calculated as 18.4% after 12 months.&#xD;
&#xD;
      The purpose of this Belgian multi-center study is to follow-up patients after recanalization&#xD;
      with the Rotarex®S catheter system (Straub Medical) for acute and subacute femoropopliteal&#xD;
      stent occlusions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 4</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>Technical success of the Rotarex device</measure>
    <time_frame>1 day post-op</time_frame>
    <description>Defined as removal of all thrombotic material, documented by angiography pre- and post-procedure: residual stenosis of the lesion &lt;30%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of procedure related complications</measure>
    <time_frame>1 day post-op</time_frame>
    <description>Embolization, amputation, perforation or hemorrhage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary patency at 6 month follow-up</measure>
    <time_frame>6 months</time_frame>
    <description>Defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the 6-month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularization (TLR)</measure>
    <time_frame>1 and 6 months</time_frame>
    <description>Defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>1 and 6 months</time_frame>
    <description>Defined as an improvement of Rutherford classification at 6 month follow-up of one class or more as compared to the pre-procedure Rutherford classification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Peripheral Vascular Disease</condition>
  <arm_group>
    <arm_group_label>Rotarex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After assessment of the lesion by angiography the occlusion is intraluminally crossed with the wire according to physician's discretion. The device is introduced and the catheter is activated while its tip is still proximal to the occlusion to allow lubrication of the spiral inside the catheter with the aspirated blood. The catheter is advanced into the occlusion with occasional retraction into the already recanalized lumen. Care must be taken to achieve sufficient cooling of the catheter tip and evacuation of the debris to get an appropriate blood flow along the catheter. In order to minimize peripheral embolization of clot the distal end of the occlusion should not be passed too fast before all loose material has been sucked back into the catheter. Several passages of the occlusion may be needed to clean out all wall-adherent thrombotic material. If residual underlying stenosis of &gt;30% persist further endovascular treatment can be performed according to the physician's discretion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rotarex S</intervention_name>
    <arm_group_label>Rotarex</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is willing to comply with specified follow-up evaluations at the specified&#xD;
             times&#xD;
&#xD;
          -  Patient is &gt;18 years old&#xD;
&#xD;
          -  Patient understands the nature of the procedure and provides written informed consent,&#xD;
             prior to enrolment in the study&#xD;
&#xD;
          -  Patient has a projected life-expectancy of at least 6 months&#xD;
&#xD;
          -  Symptomatic acute or subacute stent occlusion in the femoropopliteal artery&#xD;
&#xD;
          -  Target vessel diameter ≥ 3 mm and ≤ 8 mm&#xD;
&#xD;
          -  Patient is candidate for thrombolytic or anticoagulation medication&#xD;
&#xD;
          -  Patient is able and willing to comply with study follow-up requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No patent artery until the foot&#xD;
&#xD;
          -  Inability of crossing lesion with guidewire&#xD;
&#xD;
          -  Known active infection at the time of intervention&#xD;
&#xD;
          -  Untreated flow-limiting inflow lesions&#xD;
&#xD;
          -  Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow&#xD;
             disease just prior to enrolment&#xD;
&#xD;
          -  Aneurysm in the target vessel&#xD;
&#xD;
          -  Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy,&#xD;
             dementia, etc) or other medical condition that would preclude compliance with the&#xD;
             study protocol&#xD;
&#xD;
          -  Major distal amputation (above the transmetatarsal) in the study limb or non-study&#xD;
             limb&#xD;
&#xD;
          -  Septicemia or bacteremia&#xD;
&#xD;
          -  Any previously known coagulation disorder, including hypercoagulability&#xD;
&#xD;
          -  Contraindication to anticoagulation or antiplatelet therapy&#xD;
&#xD;
          -  Patient with known hypersensitivity to heparin, including those patients who have had&#xD;
             a previous incidence of heparin-induced thrombocytopenia (HIT) type II&#xD;
&#xD;
          -  Currently participating in another clinical research trial&#xD;
&#xD;
          -  The patient must be excluded in case any of the following contraindications as listed&#xD;
             in the IFU is present:&#xD;
&#xD;
        Rotarex®S catheters must not be used in case of:&#xD;
&#xD;
          -  Patient not suitable for thrombectomy&#xD;
&#xD;
          -  Target vessel belonging to the vessels of the cardiopulmonary, coronary or cerebral&#xD;
             circulations&#xD;
&#xD;
          -  Use inside or via undersized or oversized vessel diameters&#xD;
&#xD;
          -  Impossibility to pass the lesion completely with the guidewire&#xD;
&#xD;
          -  Subintimal position of the guidewire - even if only in short segments&#xD;
&#xD;
          -  Use in stents or stent grafts if the guidewire has become threaded at any point in the&#xD;
             wire mesh of stent or stent graft or the lining of the stent graft&#xD;
&#xD;
          -  The introducer sheath, the guide catheter, the guidewire or the Rotarex®S catheter&#xD;
             sustaining any damage, especially kinking&#xD;
&#xD;
          -  Target lesions situated in the fracture areas of broken stents&#xD;
&#xD;
          -  Known or suspected allergy to any of the components of the system or to a medicinal&#xD;
             product to be administered in connection with the planned procedure&#xD;
&#xD;
          -  Persistent vasospasm&#xD;
&#xD;
          -  Imaging by Magnetic Resonance Imaging (MRI)&#xD;
&#xD;
          -  Use of a defibrillator on the patient&#xD;
&#xD;
          -  Use of electrosurgery on the patient&#xD;
&#xD;
          -  Veterinary purposes&#xD;
&#xD;
          -  Patients with hemodynamic instability or shock&#xD;
&#xD;
          -  Patients with severe coagulatory disorders&#xD;
&#xD;
          -  Situations where an embolism potentially triggered by the use of the catheter may have&#xD;
             a very harmful effect on the patient&#xD;
&#xD;
          -  Use inside or via narrow vessel radii or in tortuous vessel courses (radius of&#xD;
             curvature &lt; 2cm)&#xD;
&#xD;
          -  Target lesion in severely calcified vessel segments&#xD;
&#xD;
          -  Target lesion in aneurysmatically altered vessel segments&#xD;
&#xD;
          -  Known or suspected infection, especially of the puncture site or the vessel segment&#xD;
             being treated&#xD;
&#xD;
          -  Known, unhealed pre-existing mechanical damage to the vessel wall, especially caused&#xD;
             by surgical procedures or interventional complications&#xD;
&#xD;
          -  Impossibility to achieve sufficient anticoagulation and platelet aggregation&#xD;
             inhibition&#xD;
&#xD;
               -  Patient is pregnant or nursing a child&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>OLV Hospital</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imelda Hospital</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Blasius</name>
      <address>
        <city>Dendermonde</city>
        <zip>9200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZA</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RZ Heilig Hart Hospital</name>
      <address>
        <city>Tienen</city>
        <zip>3300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Arterial 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/NCT02212626
org study id: FMRP-130326
nct id: NCT02212626
lead sponsor: 
The objective of this study is to evaluate the safety and efficacy of recanalization of acute
      and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub Medical)
The treatment of acute and subacute thromboembolic and local thrombotic ischemic lesions of
      the ilaco-popliteal segments in the lower extremities has undergone considerable changes over
      recent years. The standard modality of surgical thrombectomy with the Fogarty balloon
      catheter technique for acute arterial occlusions has been replaced by percutaneous catheter
      techniques, i.e. percutaneous aspiration thrombectomy (PAT) for thrombus aspiration.
      Alternatively, catheter-directed pharmacologic thrombolytic therapy with or without
      additional catheter aspiration is used, particularly if the occlusion is already a few days
      or weeks old. These techniques obtain the best results in acute occlusions of less than 2
      weeks' duration.

      Both techniques have limitations such as the application of fibrinolytic substances and
      technical, impossibility of rapid and complete thrombus extraction. Therefore various
      mechanical devices have been introduced which involve maceration or fragmentation and removal
      of thrombus. The two categories of devices for mechanical thrombectomy (MT) are: (1)
      rotational recirculation devices which work by the vortex principle, such as the Amplatz
      thrombectomy catheter (ATD, Microvena, White Bear Lake, MN) or the Arrow-Trerotola PTD (Arrow
      International, Reading, PA); and (2) hydrodynamic (rheolytic) recirculation devices which
      operate on the principle of the Venturi effect, such as the Hydrolyser (Cordis, Johnson and
      Johnson, Miami, FL), Oasis (Boston Scientific, Galway, Ireland), and the Angiojet (RTC;
      Possis Medical, Minneapolis, MN) [5-10]. These devices are not suited for subacute occlusions
      of more than 7-14 days' duration. Recently, a new rotational mechanical thrombectomy
      catheter, the Straub Rotarex / Aspirex (Straub Medical, 7323 Wangs, Switzerland) has been
      introduced. This device combines the two essential effects of mechanical clot fragmentation
      and removal of the fragmented clot material from the vessel by negative pressure. Two studies
      using the Rotarex system with 38, resp. 98 patients showed a primary patency rate of 62%,
      resp. 54% at 6 months and described the Rotarex / Aspirex systems as an efficient and quick
      technique for revascularization of acute femoropopliteal de novo occlusions. A more recent
      publication dating from 2011 reports results from using Rotarex® catheters for treatment of
      in-stent reocclusions of femoropopliteal arteries. In 78 patients, the restenosis rate was
      calculated as 18.4% after 12 months.

      The purpose of this Belgian multi-center study is to follow-up patients after recanalization
      with the Rotarex®S catheter system (Straub Medical) for acute and subacute femoropopliteal
      stent occlusions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical success of the Rotarex device
time frame: 1 day post-op
description: Defined as removal of all thrombotic material, documented by angiography pre- and post-procedure: residual stenosis of the lesion <30%.
measure: Absence of procedure related complications
time frame: 1 day post-op
description: Embolization, amputation, perforation or hemorrhage.
measure: Primary patency at 6 month follow-up
time frame: 6 months
description: Defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the 6-month follow-up.
measure: Target Lesion Revascularization (TLR)
time frame: 1 and 6 months
description: Defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.
measure: Clinical success
time frame: 1 and 6 months
description: Defined as an improvement of Rutherford classification at 6 month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
measure: Serious Adverse Events
time frame: up to 6 months
description: Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
arm group label: Rotarex
arm group type: Experimental
description: After assessment of the lesion by angiography the occlusion is intraluminally crossed with the wire according to physician's discretion. The device is introduced and the catheter is activated while its tip is still proximal to the occlusion to allow lubrication of the spiral inside the catheter with the aspirated blood. The catheter is advanced into the occlusion with occasional retraction into the already recanalized lumen. Care must be taken to achieve sufficient cooling of the catheter tip and evacuation of the debris to get an appropriate blood flow along the catheter. In order to minimize peripheral embolization of clot the distal end of the occlusion should not be passed too fast before all loose material has been sucked back into the catheter. Several passages of the occlusion may be needed to clean out all wall-adherent thrombotic material. If residual underlying stenosis of >30% persist further endovascular treatment can be performed according to the physician's discretion.
intervention type: Device
intervention name: Rotarex S
arm group label: Rotarex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Peripheral Vascular Diseases
mesh term: Peripheral Arterial Disease