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

Primary Purpose

Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Drug Eluting Balloon Angioplasty
Nitinol stenting
Sponsored by
Instituto Dante Pazzanese de Cardiologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Artery, Atherosclerosis, Peripheral, Arterial, Plaque, PTA, Angioplasty, Femoropopliteal, Self Expandable Nitinol Stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Instituto Dante Pazzanese de Cardiologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Drug Eluting Balloon

Nitinol Stent

Arm Description

Admiral In.Pact Drug Eluting Balloon

Complete SE Self-expandible Nitinol stent

Outcomes

Primary Outcome Measures

Primary patency
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

Rutherford classification
Change in classification from Rutherford evaluated in 3, 6 and 12 months.
Ankle braquial Index
Change in the Ankle braquial Index evaluated in 3, 6 and 12 months
Target Lesion Revascularization
Target Lesion Revascularization rate evaluated in 3, 6 and 12 months
Stent fracture
Stent fracture rate evaluated in 3, 6 and 12 months
Amputation
Major amputation defined as amputation that requires prosthesis
Acute myocardial infarct
Acute myocardial infarct rate evaluated in 3, 6 and 12 months
Death
Death rate evaluated in 3, 6 and 12 months

Full Information

First Posted
August 6, 2014
Last Updated
June 8, 2021
Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02212470
Brief Title
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
Acronym
PAVENST
Official Title
Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis, Cardiovascular Diseases, Peripheral Vascular Diseases, Paclitaxel, Plaque, Atherosclerotic, Critical Limb Ischemia
Keywords
Artery, Atherosclerosis, Peripheral, Arterial, Plaque, PTA, Angioplasty, Femoropopliteal, Self Expandable Nitinol Stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, single-center, single-blind, non-inferiority, clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Eluting Balloon
Arm Type
Active Comparator
Arm Description
Admiral In.Pact Drug Eluting Balloon
Arm Title
Nitinol Stent
Arm Type
Active Comparator
Arm Description
Complete SE Self-expandible Nitinol stent
Intervention Type
Device
Intervention Name(s)
Drug Eluting Balloon Angioplasty
Other Intervention Name(s)
Medtronic, Admiral In.Pact
Intervention Description
Angioplasty with Drug eluting balloon after pre dilatation
Intervention Type
Device
Intervention Name(s)
Nitinol stenting
Other Intervention Name(s)
Medtronic, Complete SE
Intervention Description
Nitinol stent deployment
Primary Outcome Measure Information:
Title
Primary patency
Description
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%
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rutherford classification
Description
Change in classification from Rutherford evaluated in 3, 6 and 12 months.
Time Frame
12 months
Title
Ankle braquial Index
Description
Change in the Ankle braquial Index evaluated in 3, 6 and 12 months
Time Frame
12 months
Title
Target Lesion Revascularization
Description
Target Lesion Revascularization rate evaluated in 3, 6 and 12 months
Time Frame
12 months
Title
Stent fracture
Description
Stent fracture rate evaluated in 3, 6 and 12 months
Time Frame
12 months
Title
Amputation
Description
Major amputation defined as amputation that requires prosthesis
Time Frame
12 months
Title
Acute myocardial infarct
Description
Acute myocardial infarct rate evaluated in 3, 6 and 12 months
Time Frame
12 months
Title
Death
Description
Death rate evaluated in 3, 6 and 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BRUNO L ALMEIDA, MD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
FABIO H ROSSI, MD, PHD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
ZIP/Postal Code
04012909
Country
Brazil

12. IPD Sharing Statement

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

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