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

C

Cordis

Status and phase

Terminated
Phase 4

Conditions

Arterial Occlusive Diseases

Treatments

Device: stent
Device: angioplasty

Study type

Interventional

Funder types

Industry

Identifiers

NCT00289055
EE04-01NL

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

1
Experimental group
Description:
Cordis SMART™ Nitinol Stent
Treatment:
Device: stent
2
Active Comparator group
Description:
balloon angioplasty
Treatment:
Device: angioplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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