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PAVENST: Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

Sponsor
Instituto Dante Pazzanese de Cardiologia (Other)
Overall Status
Completed
CT.gov ID
NCT02212470
Collaborator
Medtronic (Industry)
85
Enrollment
1
Location
2
Arms
63
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.

Condition or Disease Intervention/Treatment Phase
  • Device: Drug Eluting Balloon Angioplasty
  • Device: Nitinol stenting
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, randomized, single-center, single-blind, non-inferiority, clinical trialProspective, randomized, single-center, single-blind, non-inferiority, clinical trial
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
Actual Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Drug Eluting Balloon

Admiral In.Pact Drug Eluting Balloon

Device: Drug Eluting Balloon Angioplasty
Angioplasty with Drug eluting balloon after pre dilatation
Other Names:
  • Medtronic
  • Admiral In.Pact

    		•
    Active Comparator: Nitinol Stent

    Complete SE Self-expandible Nitinol stent

    Device: Nitinol stenting
    Nitinol stent deployment
    Other Names:
  • Medtronic
  • Complete SE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary patency [12 months]

      Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50%

    Secondary Outcome Measures

    1. Rutherford classification [12 months]

      Change in classification from Rutherford evaluated in 3, 6 and 12 months.

    2. Ankle braquial Index [12 months]

      Change in the Ankle braquial Index evaluated in 3, 6 and 12 months

    3. Target Lesion Revascularization [12 months]

      Target Lesion Revascularization rate evaluated in 3, 6 and 12 months

    4. Stent fracture [12 months]

      Stent fracture rate evaluated in 3, 6 and 12 months

    5. Amputation [12 months]

      Major amputation defined as amputation that requires prosthesis

    6. Acute myocardial infarct [12 months]

      Acute myocardial infarct rate evaluated in 3, 6 and 12 months

    7. Death [12 months]

      Death rate evaluated in 3, 6 and 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients over 18 years with critical lower limb ischemia,

    • Ruhtherford 3 or higher,

    • with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery,

    • with a maximum extension of 10 cm stenosis.

    • The popliteal artery and at least one leg artery must be patent.

    Exclusion Criteria:

    • Pregnancy,

    • thrombophilia,

    • coagulation disorders,

    • presence of active or recent bleeding,

    • severe allergy to iodinated contrast,

    • renal or hepatic disease,

    • acute limb ischemia,

    • prior surgical bypass or angioplasty (with or without stent) on the target artery,

    • obstructive disease (stenosis> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Dante Pazzanese de Cardiologia Sao Paulo Brazil 04012909

    Sponsors and Collaborators

    • Instituto Dante Pazzanese de Cardiologia
    • Medtronic

    Investigators

    • Principal Investigator: BRUNO L ALMEIDA, MD, Instituto Dante Pazzanese de Cardiologia
    • Study Director: FABIO H ROSSI, MD, PHD, Instituto Dante Pazzanese de Cardiologia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fabio H Rossi, MD, PHD, Instituto Dante Pazzanese de Cardiologia
    ClinicalTrials.gov Identifier:
    NCT02212470
    Other Study ID Numbers:
    • IDPC_3 2014
    First Posted:
    Aug 8, 2014
    Last Update Posted:
    Jun 10, 2021
    Last Verified:
    Jun 1, 2021
    Keywords provided by Fabio H Rossi, MD, PHD, Instituto Dante Pazzanese de Cardiologia
    Artery
    Atherosclerosis
    Peripheral
    Arterial
    Plaque
    PTA
    Angioplasty
    Femoropopliteal
    Self Expandable Nitinol Stents
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Atherosclerosis
    Peripheral Arterial Disease
    Peripheral Vascular Diseases
    Vascular Diseases
    Arteriosclerosis
    Arterial Occlusive Diseases
    Ischemia
    Plaque, Atherosclerotic

    Study Results

    No Results Posted as of Jun 10, 2021