The Study to Treat Superficial Femoral Artery Occlusions.

Phase 4

Completed

• Conditions: Arterial Occlusive Diseases
• Interventions: Device: stent; Device: angioplasty

• Registration Number: NCT00232843
• Lead Sponsor: Cordis Corporation

Brief Summary

The main objective of this study is to assess the performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as determined by binary restenosis at one year.

Detailed Description

This is a multi-center, prospective, randomized, two-arm study evaluating the performance of the Cordis SMART™ nitinol self-expanding stent as compared to angioplasty only.

It is anticipated that a total of 150 patients will be entered into the study. Patients will be randomized on a 1:1 basis of stent versus angioplasty only.

150 patients with de novo or restenotic native SFA occlusions (5-22 cm) with reference vessel of \>= 4.0 to \<= 6.0 mm in diameter will be randomized to the SMART™ nitinol self-expanding stent or to angioplasty only.

All patients will be followed for 12 months post-procedure, by telephone contact at 3 and 6 months, and a 12 month clinical and duplex ultrasound assessment. This study will be conducted at up to 12 investigational sites.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-05
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-02
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• One superficial femoral artery de novo or restenotic lesion (> 70% stenosis or occlusions), with a lesion length > 5 to < 22 cm.
• Patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure. Additional intervention to further improve blood flow to the lower limb is acceptable during the index procedure, but after successful treatment of the study lesions

Exclusion Criteria

• Revascularisation involving the same limb within 7 days prior to the index procedure or a planned revascularisation within 7 days after the index procedure Patient having total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow is allowed during the same procedure and prior to the treatment of the study lesion.
• Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of the Cordis medical monitor and the principal investigator of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	stent	Cordis SMART™ nitinol self-expanding stent.
2	angioplasty	balloon angioplasty

Primary Outcome Measures

Name	Time	Method
Binary restenosis as demonstrated by Duplex Ultrasound.	1 year

Secondary Outcome Measures

Name	Time	Method
Device success.	at time of deployment
Ankle Brachial Index	at discharge and 12 months
Procedural success: defined as successful recanalization, without the occurrence of a SAE event.	up to the moment the catheter sheath introducer has been removed
Restenosis measured by Duplex Ultrasound	at discharge and 12 months

Trial Locations

Locations (2)

University Hospital of North Staffordshire; 🇬🇧 Newcastle under Lyme, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom