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

June 8, 2021 updated by: Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia

Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04012909
        • Instituto Dante Pazzanese de Cardiologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary patency
Time Frame: 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%
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Dante Pazzanese de Cardiologia

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 8, 2014

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDPC_3 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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