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

This study has been terminated.
(lack of enrollment)
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00289055
First received: February 7, 2006
Last updated: February 20, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Arterial Occlusive Diseases
 Device: stent
Device: angioplasty
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • Primary patency. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography. [ Time Frame: at deployment ] [ Designated as safety issue: No ]
  • Procedural success defined as successful recanalization, without the occurrence of a SAE. [ Time Frame: up to the moment haemostasis has been achieved ] [ Designated as safety issue: No ]
  • Procedural complications, defined as any adverse event [ Time Frame: from start of the procedure up to the moment haemostasis has been achieved ] [ Designated as safety issue: Yes ]
  • Ankle Brachial Index. [ Time Frame: discharge and 12 months ] [ Designated as safety issue: Yes ]
  • Treadmill test. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Restenosis measured by Duplex Ultrasound. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of Life assessment. [ Time Frame: baseline, 6, and 12 months post procedure ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cordis SMART™ Nitinol Stent
 Device: stent
Cordis SMART™ Nitinol Stent
Active Comparator: 2
balloon angioplasty
 Device: angioplasty
balloon angioplasty

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289055

Locations
Netherlands
AMC
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Jim Reekers, MD AMC Amsterdam
  More Information

No publications provided

Responsible Party: Dr. Hans-Peter Stoll - Medical Affairs Director, Cordis
ClinicalTrials.gov Identifier: NCT00289055     History of Changes
Other Study ID Numbers: EE04-01NL
Study First Received: February 7, 2006
Last Updated: February 20, 2009
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Cordis Corporation:
Peripheral Artery Occlusive Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013