<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/NCT04442802</url>
  </required_header>
  <id_info>
    <org_study_id>LOVES_RCT_2020</org_study_id>
    <nct_id>NCT04442802</nct_id>
  </id_info>
  <brief_title>Arterial Dissections After Angioplasty by Long vs Short Time of Balloon Inflation: the Randomized Controlled Trial.</brief_title>
  <acronym>LOVES</acronym>
  <official_title>Rate of Severe Arterial Dissections After Femoropopliteal Angioplasty by Long Versus Short Time of Balloon Inflation: the LOVES Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dumitru Casian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background. Arterial dissections represent the typical complication of the percutaneous&#xD;
      transluminal angioplasty for femoropopliteal disease and have negative impact upon the&#xD;
      outcomes of the treatment.&#xD;
&#xD;
      Objective. The study is aimed to test the hypothesis that a prolonged (6 minutes) time of&#xD;
      inflation of angioplasty balloon would reduce the rate of severe arterial dissections and&#xD;
      necessity in bailout stenting during the treatment of occlusive-stenotic femoropopliteal&#xD;
      lesions in patients with chronic limb threatening ischemia.&#xD;
&#xD;
      Methods. The LOVES trial is a single centre, two parallel groups, controlled trial with 1:1&#xD;
      randomization. Participants will be recruited among the patients hospitalized in Vascular&#xD;
      Surgery Department of Institute of Emergency Medicine, Chisinau, Republic of Moldova.&#xD;
&#xD;
      Procedure. Diagnostic angiography of the treated limb will be performed first to confirm the&#xD;
      presence of stenosis ≥50% or occlusion in the superficial femoral and/or popliteal artery.&#xD;
      After crossing of the lesion patient will be supposed to randomization. In the intervention&#xD;
      group the angioplasty balloon will be inflated for 6 minutes. In the control group - for 3&#xD;
      minutes.&#xD;
&#xD;
      Presence and severity (grades A-B or C-F according to NHLBI classification) of dissection&#xD;
      will be assessed independently by 3 study investigators basing on completion angiography.&#xD;
      Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting&#xD;
      will be done by the agreement between at least 2 investigators.&#xD;
&#xD;
      Sample size. Basing on the results of previous retrospective study investigators expect the&#xD;
      23% rate of severe dissection in study group (6 minutes inflation) and 51% - in control group&#xD;
      (3 minutes inflation). Using the probability of type I error of 0.05 and power set at 80%&#xD;
      investigators have calculated that 45 patients are required for each group. Anticipating 10%&#xD;
      rate of loss to follow-up, 50 patients will be randomized per treatment arm.&#xD;
&#xD;
      Randomization. One hundred patients will be allocated to study or control group by two blocks&#xD;
      1:1 randomization using the free online application Research Randomizer, version 4 (Urbaniak&#xD;
      GC, Plous S., 2013, http://www.randomizer.org/).&#xD;
&#xD;
      Follow-up. Three follow up visits at 1, 6 and 12 months are scheduled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background. Arterial dissections represent the typical complication of the percutaneous&#xD;
      transluminal angioplasty for femoropopliteal disease, with an incidence of 20-60% depending&#xD;
      of the severity of treated lesion and reporting standards. Post-angioplasty dissections have&#xD;
      negative impact upon the outcomes of the endovascular treatment of lower limb arterial&#xD;
      disease. Severe flow limiting dissections require immediate treatment by bailout stenting.&#xD;
      Although this strategy is effective in the short term there is a substantial risk of in-stent&#xD;
      restenosis, stent thrombosis, and stent fracture with the long-term follow-up. Moreover, it&#xD;
      was demonstrated that even minor dissections that required no treatment during the initial&#xD;
      procedure with time can progress to significant arterial stensosis. Finally, stenting&#xD;
      significantly increases the cost of intervention.&#xD;
&#xD;
      Improved results of peripheral arterial balloon angioplasty with balloon inflation time of 3&#xD;
      minutes comparing to 1 minute were reported previously. A randomized study performed in&#xD;
      patients with stenosis of the vascular access for haemodialysis demonstrated 14% difference&#xD;
      in technical success of angioplasty, favouring the 3 minutes balloon inflation time vs one&#xD;
      minute. Recently published retrospective single centre study demonstrated that balloon&#xD;
      angioplasty with a prolonged inflation time &gt;3 minutes may be effective as an initial&#xD;
      angioplasty strategy to prevent severe dissection in femoropopliteal lesions. Type C or&#xD;
      higher dissections according to NHLBI (National Heart, Lung and Blood Institute)&#xD;
      classification were observed less frequently after &gt;3 minutes balloon inflation - 22.7% vs&#xD;
      50.9% in &lt;3-minute group. However, the rate of provisional stenting was not significantly&#xD;
      different between groups.&#xD;
&#xD;
      Objective. The study is aimed to test the hypothesis that a prolonged (6 minutes) time of&#xD;
      inflation of angioplasty balloon would reduce the rate of severe (grade C-F) arterial&#xD;
      dissections and necessity in bailout stenting during the treatment of occlusive-stenotic&#xD;
      femoropopliteal lesions in patients with chronic limb threatening ischemia.&#xD;
&#xD;
      Methods. The LOVES (LOng VErsus Short) trial is a single centre, two parallel groups, open&#xD;
      label, controlled trial with 1:1 randomization. The eligible participants in the study will&#xD;
      be adults aged 18 years or over who met the inclusion criteria.&#xD;
&#xD;
      Recruitment. Participants in the LOVES trial will be recruited starting with September 2020&#xD;
      among the patients hospitalized in Vascular Surgery Department of Institute of Emergency&#xD;
      Medicine, Chisinau, Republic of Moldova. All patients eligible for enrollment in to the study&#xD;
      will be asked to sign informed consent. Only one extremity per patient may be included in the&#xD;
      trial. If both legs meet the inclusion criteria, the leg with the most severe complaints will&#xD;
      be treated first and will be included in the trial.&#xD;
&#xD;
      Procedure. The endovascular intervention will be performed in the dedicated suite under local&#xD;
      anesthesia. All types of the arterial access (brachial, femoral crossover, femoral&#xD;
      anterograd) will be allowed. After arterial access patients from both arms will receive 5000&#xD;
      IU of heparin intravenously. Diagnostic angiography of the treated limb will be performed&#xD;
      first to confirm the presence of stenosis ≥50% or occlusion in the superficial femoral and/or&#xD;
      popliteal artery. After successful intraluminal crossing of the femoropopliteal lesion&#xD;
      patient will be supposed to randomization.&#xD;
&#xD;
      In the intervention group (long time inflation) the plain old (non drug eluting) angioplasty&#xD;
      balloon will be positioned in the affected arterial segment and inflated up to nominal&#xD;
      pressure for 6 minutes. In the control group (short time inflation) the plain old (non drug&#xD;
      eluting) angioplasty balloon will be positioned in the affected arterial segment and inflated&#xD;
      up to nominal pressure for 3 minutes. The length and diameter of the balloon will be selected&#xD;
      by operator basing on reference images.&#xD;
&#xD;
      After balloon deflation and extraction the completion angiography will be performed. Presence&#xD;
      (yes/no) and severity (grades A-B or C-F according to NHLBI classification) of dissection&#xD;
      will be assessed independently by 3 study investigators basing on DSA images in 2 directions.&#xD;
      Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting&#xD;
      will be done by the agreement between at least 2 from 3 investigators. Self expandable and&#xD;
      balloon expandable non drug eluting stents either will be allowed for implantation.&#xD;
&#xD;
      Additional endovascular interventions in the inflow (aorto-iliac segment) or outflow&#xD;
      (infrapopliteal segment) arteries may be performed. These treatments will be registered,&#xD;
      reported but not analyzed as study endpoints.&#xD;
&#xD;
      Postoperative antithrombotic treatment will be identical in both groups. After loading dose&#xD;
      of clopidogrel (300 mg) patients will receive the 75 mg of clopidogrel and 75 mg of aspirin&#xD;
      for 3 months.&#xD;
&#xD;
      Sample size. Basing on the results of previous studies investigators expect the 23% rate of&#xD;
      severe dissection in study group (6 minutes inflation) and 51% - in control group (3 minutes&#xD;
      inflation). Using the probability of type I error of 0.05 and power set at 80% investigators&#xD;
      have calculated that 45 patients are required for each group. Anticipating 10% rate of loss&#xD;
      to follow-up, 50 patients will be randomized per treatment arm.&#xD;
&#xD;
      Randomization. Randomization of the patients will be performed by designated study&#xD;
      investigator after successful intraluminal crossing of the target lesion. One hundred&#xD;
      patients will be allocated to study or control group by two blocks 1:1 randomization using&#xD;
      the free online application Research Randomizer, version 4 (http://www.randomizer.org/).&#xD;
&#xD;
      Blinding. Surgeons participating in endovascular procedure and assessing the severity of the&#xD;
      dissection can not respect the blinding because their implication in the inflation/deflation&#xD;
      of the angioplasty balloon. Patients will be blinded to the treatment they receive. The time&#xD;
      of balloon inflation will be not documented in the patient's medical record. Vascular&#xD;
      technician who will perform the ABI measurement and duplex ultrasound will be not aware of&#xD;
      time of balloon inflation during angioplasty.&#xD;
&#xD;
      Follow-up. Three follow up visits at 1, 6 and 12 months are scheduled according to the&#xD;
      standards of management after endovascular peripheral arterial interventions. Physical&#xD;
      examination, ABI measurement and duplex ultrasound will be performed during the follow-up&#xD;
      visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Actual">June 22, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severe post-angioplasty dissection in femoropopliteal arterial segment</measure>
    <time_frame>5 minutes after deflation of angioplasty balloon</time_frame>
    <description>Post-angioplasty dissection of grades C-F according to NHLBI (National Heart, Lung and Blood Institute) classification, determined by the agreement between at least 2 from 3 study investigators basing on completion DSA results</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success of the procedure</measure>
    <time_frame>10 minutes after completion of balloon angioplasty +/- stenting</time_frame>
    <description>Residual stenosis in femoropopliteal segment &lt;30%, according to the DSA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ankle-Brahial Index</measure>
    <time_frame>24 hours after intervention</time_frame>
    <description>Increase or decrease of the ABI by at least 0.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary patency</measure>
    <time_frame>During the follow-up visits (1, 6, 12 months)</time_frame>
    <description>Absence of occlusion or stenosis ≥50% in femoropopliteal segment assessed by duplex ultrasound (peak systolic velocity ratio &gt;2.5) and freedom from target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Limb loss</measure>
    <time_frame>During the follow-up visits (1, 6, 12 months)</time_frame>
    <description>Above the ankle amputation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Dissection Arterial</condition>
  <arm_group>
    <arm_group_label>Long time balloon inflation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the endovascular intervention the angioplasty balloon will be inflated for 6 minutes to treat the occlusive-stenotic femoropopliteal arterial lesion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short time balloon inflation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the endovascular intervention the angioplasty balloon will be inflated for 3 minutes to treat the occlusive-stenotic femoropopliteal arterial lesion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous transluminal angioplasty</intervention_name>
    <description>Under local anesthesia the percutaneous arterial access will be created. Digital subtraction angiography of the whole limb will be performed. Occlusive-stenotic lesion of the superficial femoral and / or popliteal artery will be crossed with a guidewire. The plain old (non drug-eluting) will be positioned in the affected arterial segment and inflated up to nominal pressure. After balloon deflation and extraction the completion angiography will be performed. Presence (yes/no) and severity (grades A-B or C-F according to NHLBI classification) of dissection will be assessed independently by 3 study investigators basing on DSA images in 2 directions. Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting will be done by the agreement between at least 2 from 3 investigators.</description>
    <arm_group_label>Long time balloon inflation</arm_group_label>
    <arm_group_label>Short time balloon inflation</arm_group_label>
    <other_name>Plain old balloon angioplasty</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chronic limb threatening ischemia category 4-6 according to Rutherford classification;&#xD;
&#xD;
          2. Ankle-brachial index &lt;0.8 or &gt;1.4&#xD;
&#xD;
          3. Clinical stage ≥2 of WIfI (Wound, Ischemia, foot Infection) classification;&#xD;
&#xD;
          4. Stenosis of ≥50% or occlusion in superficial femoral or popliteal artery, confirmed by&#xD;
             duplex ultrasound, computer tomography angiography or digital subtraction angiography;&#xD;
&#xD;
          5. Use of endovascular approach for treatment of the lesion;&#xD;
&#xD;
          6. Patient willing to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute arterial occlusion (symptoms duration less than 14 days);&#xD;
&#xD;
          2. Recurrent stenosis or occlusion of femoropopliteal segment;&#xD;
&#xD;
          3. Impossibility to cross the lesion intraluminally during the endovascular intervention;&#xD;
&#xD;
          4. Life expectancy of less than 1 year -&#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_official>
    <last_name>Dumitru Casian, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nicolae Testemitanu State University of Medicine and Pharmacy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nicolae Testemitanu State University of Medicine and Pharmacy, Department of surgery nr.3, Vascular Surgery Clinic</name>
      <address>
        <city>Chisinau</city>
        <zip>2001</zip>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Moldova, Republic of</country>
  </location_countries>
  <reference>
    <citation>Zorger N, Manke C, Lenhart M, Finkenzeller T, Djavidani B, Feuerbach S, Link J. Peripheral arterial balloon angioplasty: effect of short versus long balloon inflation times on the morphologic results. J Vasc Interv Radiol. 2002 Apr;13(4):355-9. doi: 10.1016/s1051-0443(07)61736-9.</citation>
    <PMID>11932365</PMID>
  </reference>
  <reference>
    <citation>Forauer AR, Hoffer EK, Homa K. Dialysis access venous stenoses: treatment with balloon angioplasty--1- versus 3-minute inflation times. Radiology. 2008 Oct;249(1):375-81. doi: 10.1148/radiol.2491071845.</citation>
    <PMID>18796688</PMID>
  </reference>
  <reference>
    <citation>Horie K, Tanaka A, Taguri M, Kato S, Inoue N. Impact of Prolonged Inflation Times During Plain Balloon Angioplasty on Angiographic Dissection in Femoropopliteal Lesions. J Endovasc Ther. 2018 Dec;25(6):683-691. doi: 10.1177/1526602818799733. Epub 2018 Sep 11.</citation>
    <PMID>30203701</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2022</last_update_submitted>
  <last_update_submitted_qc>June 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu</investigator_affiliation>
    <investigator_full_name>Dumitru Casian</investigator_full_name>
    <investigator_title>Associate Professor Department of General surgery nr.3, Head of Vascular Surgery Clinic</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Dissection, Blood Vessel</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04442802
org study id: LOVES_RCT_2020
nct id: NCT04442802
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background. Arterial dissections represent the typical complication of the percutaneous
      transluminal angioplasty for femoropopliteal disease and have negative impact upon the
      outcomes of the treatment.

      Objective. The study is aimed to test the hypothesis that a prolonged (6 minutes) time of
      inflation of angioplasty balloon would reduce the rate of severe arterial dissections and
      necessity in bailout stenting during the treatment of occlusive-stenotic femoropopliteal
      lesions in patients with chronic limb threatening ischemia.

      Methods. The LOVES trial is a single centre, two parallel groups, controlled trial with 1:1
      randomization. Participants will be recruited among the patients hospitalized in Vascular
      Surgery Department of Institute of Emergency Medicine, Chisinau, Republic of Moldova.

      Procedure. Diagnostic angiography of the treated limb will be performed first to confirm the
      presence of stenosis ≥50% or occlusion in the superficial femoral and/or popliteal artery.
      After crossing of the lesion patient will be supposed to randomization. In the intervention
      group the angioplasty balloon will be inflated for 6 minutes. In the control group - for 3
      minutes.

      Presence and severity (grades A-B or C-F according to NHLBI classification) of dissection
      will be assessed independently by 3 study investigators basing on completion angiography.
      Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting
      will be done by the agreement between at least 2 investigators.

      Sample size. Basing on the results of previous retrospective study investigators expect the
      23% rate of severe dissection in study group (6 minutes inflation) and 51% - in control group
      (3 minutes inflation). Using the probability of type I error of 0.05 and power set at 80%
      investigators have calculated that 45 patients are required for each group. Anticipating 10%
      rate of loss to follow-up, 50 patients will be randomized per treatment arm.

      Randomization. One hundred patients will be allocated to study or control group by two blocks
      1:1 randomization using the free online application Research Randomizer, version 4 (Urbaniak
      GC, Plous S., 2013, http://www.randomizer.org/).

      Follow-up. Three follow up visits at 1, 6 and 12 months are scheduled.
Background. Arterial dissections represent the typical complication of the percutaneous
      transluminal angioplasty for femoropopliteal disease, with an incidence of 20-60% depending
      of the severity of treated lesion and reporting standards. Post-angioplasty dissections have
      negative impact upon the outcomes of the endovascular treatment of lower limb arterial
      disease. Severe flow limiting dissections require immediate treatment by bailout stenting.
      Although this strategy is effective in the short term there is a substantial risk of in-stent
      restenosis, stent thrombosis, and stent fracture with the long-term follow-up. Moreover, it
      was demonstrated that even minor dissections that required no treatment during the initial
      procedure with time can progress to significant arterial stensosis. Finally, stenting
      significantly increases the cost of intervention.

      Improved results of peripheral arterial balloon angioplasty with balloon inflation time of 3
      minutes comparing to 1 minute were reported previously. A randomized study performed in
      patients with stenosis of the vascular access for haemodialysis demonstrated 14% difference
      in technical success of angioplasty, favouring the 3 minutes balloon inflation time vs one
      minute. Recently published retrospective single centre study demonstrated that balloon
      angioplasty with a prolonged inflation time >3 minutes may be effective as an initial
      angioplasty strategy to prevent severe dissection in femoropopliteal lesions. Type C or
      higher dissections according to NHLBI (National Heart, Lung and Blood Institute)
      classification were observed less frequently after >3 minutes balloon inflation - 22.7% vs
      50.9% in <3-minute group. However, the rate of provisional stenting was not significantly
      different between groups.

      Objective. The study is aimed to test the hypothesis that a prolonged (6 minutes) time of
      inflation of angioplasty balloon would reduce the rate of severe (grade C-F) arterial
      dissections and necessity in bailout stenting during the treatment of occlusive-stenotic
      femoropopliteal lesions in patients with chronic limb threatening ischemia.

      Methods. The LOVES (LOng VErsus Short) trial is a single centre, two parallel groups, open
      label, controlled trial with 1:1 randomization. The eligible participants in the study will
      be adults aged 18 years or over who met the inclusion criteria.

      Recruitment. Participants in the LOVES trial will be recruited starting with September 2020
      among the patients hospitalized in Vascular Surgery Department of Institute of Emergency
      Medicine, Chisinau, Republic of Moldova. All patients eligible for enrollment in to the study
      will be asked to sign informed consent. Only one extremity per patient may be included in the
      trial. If both legs meet the inclusion criteria, the leg with the most severe complaints will
      be treated first and will be included in the trial.

      Procedure. The endovascular intervention will be performed in the dedicated suite under local
      anesthesia. All types of the arterial access (brachial, femoral crossover, femoral
      anterograd) will be allowed. After arterial access patients from both arms will receive 5000
      IU of heparin intravenously. Diagnostic angiography of the treated limb will be performed
      first to confirm the presence of stenosis ≥50% or occlusion in the superficial femoral and/or
      popliteal artery. After successful intraluminal crossing of the femoropopliteal lesion
      patient will be supposed to randomization.

      In the intervention group (long time inflation) the plain old (non drug eluting) angioplasty
      balloon will be positioned in the affected arterial segment and inflated up to nominal
      pressure for 6 minutes. In the control group (short time inflation) the plain old (non drug
      eluting) angioplasty balloon will be positioned in the affected arterial segment and inflated
      up to nominal pressure for 3 minutes. The length and diameter of the balloon will be selected
      by operator basing on reference images.

      After balloon deflation and extraction the completion angiography will be performed. Presence
      (yes/no) and severity (grades A-B or C-F according to NHLBI classification) of dissection
      will be assessed independently by 3 study investigators basing on DSA images in 2 directions.
      Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting
      will be done by the agreement between at least 2 from 3 investigators. Self expandable and
      balloon expandable non drug eluting stents either will be allowed for implantation.

      Additional endovascular interventions in the inflow (aorto-iliac segment) or outflow
      (infrapopliteal segment) arteries may be performed. These treatments will be registered,
      reported but not analyzed as study endpoints.

      Postoperative antithrombotic treatment will be identical in both groups. After loading dose
      of clopidogrel (300 mg) patients will receive the 75 mg of clopidogrel and 75 mg of aspirin
      for 3 months.

      Sample size. Basing on the results of previous studies investigators expect the 23% rate of
      severe dissection in study group (6 minutes inflation) and 51% - in control group (3 minutes
      inflation). Using the probability of type I error of 0.05 and power set at 80% investigators
      have calculated that 45 patients are required for each group. Anticipating 10% rate of loss
      to follow-up, 50 patients will be randomized per treatment arm.

      Randomization. Randomization of the patients will be performed by designated study
      investigator after successful intraluminal crossing of the target lesion. One hundred
      patients will be allocated to study or control group by two blocks 1:1 randomization using
      the free online application Research Randomizer, version 4 (http://www.randomizer.org/).

      Blinding. Surgeons participating in endovascular procedure and assessing the severity of the
      dissection can not respect the blinding because their implication in the inflation/deflation
      of the angioplasty balloon. Patients will be blinded to the treatment they receive. The time
      of balloon inflation will be not documented in the patient's medical record. Vascular
      technician who will perform the ABI measurement and duplex ultrasound will be not aware of
      time of balloon inflation during angioplasty.

      Follow-up. Three follow up visits at 1, 6 and 12 months are scheduled according to the
      standards of management after endovascular peripheral arterial interventions. Physical
      examination, ABI measurement and duplex ultrasound will be performed during the follow-up
      visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Severe post-angioplasty dissection in femoropopliteal arterial segment
time frame: 5 minutes after deflation of angioplasty balloon
description: Post-angioplasty dissection of grades C-F according to NHLBI (National Heart, Lung and Blood Institute) classification, determined by the agreement between at least 2 from 3 study investigators basing on completion DSA results
measure: Technical success of the procedure
time frame: 10 minutes after completion of balloon angioplasty +/- stenting
description: Residual stenosis in femoropopliteal segment <30%, according to the DSA
measure: Change in Ankle-Brahial Index
time frame: 24 hours after intervention
description: Increase or decrease of the ABI by at least 0.1
measure: Primary patency
time frame: During the follow-up visits (1, 6, 12 months)
description: Absence of occlusion or stenosis ≥50% in femoropopliteal segment assessed by duplex ultrasound (peak systolic velocity ratio >2.5) and freedom from target lesion revascularization
measure: Limb loss
time frame: During the follow-up visits (1, 6, 12 months)
description: Above the ankle amputation
arm group label: Long time balloon inflation
arm group type: Experimental
description: During the endovascular intervention the angioplasty balloon will be inflated for 6 minutes to treat the occlusive-stenotic femoropopliteal arterial lesion
arm group label: Short time balloon inflation
arm group type: Active Comparator
description: During the endovascular intervention the angioplasty balloon will be inflated for 3 minutes to treat the occlusive-stenotic femoropopliteal arterial lesion
intervention type: Procedure
intervention name: Percutaneous transluminal angioplasty
description: Under local anesthesia the percutaneous arterial access will be created. Digital subtraction angiography of the whole limb will be performed. Occlusive-stenotic lesion of the superficial femoral and / or popliteal artery will be crossed with a guidewire. The plain old (non drug-eluting) will be positioned in the affected arterial segment and inflated up to nominal pressure. After balloon deflation and extraction the completion angiography will be performed. Presence (yes/no) and severity (grades A-B or C-F according to NHLBI classification) of dissection will be assessed independently by 3 study investigators basing on DSA images in 2 directions. Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting will be done by the agreement between at least 2 from 3 investigators.
arm group label: Long time balloon inflation
arm group label: Short time balloon inflation
other name: Plain old balloon angioplasty
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dumitru Casian, MD, PhD
role: Principal Investigator
affiliation: Nicolae Testemitanu State University of Medicine and Pharmacy
facility: 
country: Moldova, Republic of
citation: Zorger N, Manke C, Lenhart M, Finkenzeller T, Djavidani B, Feuerbach S, Link J. Peripheral arterial balloon angioplasty: effect of short versus long balloon inflation times on the morphologic results. J Vasc Interv Radiol. 2002 Apr;13(4):355-9. doi: 10.1016/s1051-0443(07)61736-9.
PMID: 11932365
citation: Forauer AR, Hoffer EK, Homa K. Dialysis access venous stenoses: treatment with balloon angioplasty--1- versus 3-minute inflation times. Radiology. 2008 Oct;249(1):375-81. doi: 10.1148/radiol.2491071845.
PMID: 18796688
citation: Horie K, Tanaka A, Taguri M, Kato S, Inoue N. Impact of Prolonged Inflation Times During Plain Balloon Angioplasty on Angiographic Dissection in Femoropopliteal Lesions. J Endovasc Ther. 2018 Dec;25(6):683-691. doi: 10.1177/1526602818799733. Epub 2018 Sep 11.
PMID: 30203701
responsible party type: Sponsor-Investigator
investigator affiliation: Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
investigator full name: Dumitru Casian
investigator title: Associate Professor Department of General surgery nr.3, Head of Vascular Surgery Clinic
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Dissection, Blood Vessel
sharing ipd: No