The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions. (DURAVEST)

February 20, 2009 updated by: Cordis Corporation

A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions

The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.

The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.

Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only.

Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.

This study will be conducted at 8 investigational sites in The Netherlands.

Study Type

Interventional

Enrollment (Actual)

10

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

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months
  2. The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.

Exclusion Criteria:

  1. Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
  2. Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded.
  3. Gangrene in index limb (Rutherford category 6).

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cordis SMART™ Nitinol Stent
Device: stent
Cordis SMART™ Nitinol Stent
Active Comparator: 2
balloon angioplasty
Device: angioplasty
balloon angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary patency.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography.
Time Frame: at deployment
at deployment
Procedural success defined as successful recanalization, without the occurrence of a SAE.
Time Frame: up to the moment haemostasis has been achieved
up to the moment haemostasis has been achieved
Procedural complications, defined as any adverse event
Time Frame: from start of the procedure up to the moment haemostasis has been achieved
from start of the procedure up to the moment haemostasis has been achieved
Ankle Brachial Index.
Time Frame: discharge and 12 months
discharge and 12 months
Treadmill test.
Time Frame: 12 months
12 months
Restenosis measured by Duplex Ultrasound.
Time Frame: 12 months
12 months
Quality of Life assessment.
Time Frame: baseline, 6, and 12 months post procedure
baseline, 6, and 12 months post procedure

Collaborators and Investigators

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

Sponsor

Cordis Corporation

Investigators

  • Principal Investigator: Jim Reekers, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

November 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 8, 2006

First Posted (Estimate)

February 9, 2006

Study Record Updates

Last Update Posted (Estimate)

February 24, 2009

Last Update Submitted That Met QC Criteria

February 20, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EE04-01NL

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.

Clinical Trials on Arterial Occlusive Diseases

Clinical Trials on stent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe