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

Arterial Occlusive Diseases Clinical Trial

— DURAVEST  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00289055
• Other study ID #: EE04-01NL
• Status: Terminated
• Phase: Phase 4
• First received: February 7, 2006
• Last updated: February 20, 2009
• Start date: November 2005
• Est. completion date: June 2008

Study information

• Verified date: February 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

Device:
• stent
Cordis SMART™ Nitinol Stent
• angioplasty
balloon angioplasty

Locations

Country	Name	City	State
Netherlands	AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency.		12 months	Yes
Secondary	Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography.		at deployment	No
Secondary	Procedural success defined as successful recanalization, without the occurrence of a SAE.		up to the moment haemostasis has been achieved	No
Secondary	Procedural complications, defined as any adverse event		from start of the procedure up to the moment haemostasis has been achieved	Yes
Secondary	Ankle Brachial Index.		discharge and 12 months	Yes
Secondary	Treadmill test.		12 months	Yes
Secondary	Restenosis measured by Duplex Ultrasound.		12 months	Yes
Secondary	Quality of Life assessment.		baseline, 6, and 12 months post procedure	Yes