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

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ClinicalTrials.gov Identifier: NCT00289055
Recruitment Status : Terminated (lack of enrollment)
First Posted : February 9, 2006
Last Update Posted : February 24, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Arterial Occlusive Diseases Device: stent Device: angioplasty Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2005
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Primary patency. [ Time Frame: 12 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289055


Locations
Netherlands
AMC
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Jim Reekers, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information

Responsible Party: Dr. Hans-Peter Stoll - Medical Affairs Director, Cordis
ClinicalTrials.gov Identifier: NCT00289055     History of Changes
Other Study ID Numbers: EE04-01NL
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009

Keywords provided by Cordis Corporation:
Peripheral Artery Occlusive Disease

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