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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00235131
Other study ID # EE04-02
Secondary ID
Status Completed
Phase Phase 4
First received October 4, 2005
Last updated February 3, 2010
Start date May 2005
Est. completion date May 2009

Study information

Verified date February 2010
Source Cordis Corporation
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C & D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure.


Description:

This is a German multi-center prospective, randomized, two-arm study evaluating performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard® Luminexx™ 6F Vascular Stent. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 200 patients will be entered into the study.

The study population will consist of approximately 200 symptomatic peripheral vascular disease patients with TASC C & D SFA lesions. The disease will consist of symptomatic, long de novo or restenotic lesions (> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic imaging. The lesion must not extend into the distal SFA and the popliteal artery. At least one distal popliteal artery must be patent as well as one calf vessel. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.

Trial participants will be randomized to the Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System or to the Bard® Luminexx™ 6F Vascular Stent.

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 over up to 15 investigational sites in Germany.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 2009
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Symptomatic leg ischemia by Rutherford classification (category 2, 3, 4 or 5); duration of intermittent claudication (category 2-3) should be at least 3 months.

- One superficial femoral artery de novo or restenotic lesion (more than 70% stenosis or occlusions), with a lesion length of more than 5 to less than 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.

Exclusion Criteria:

- Revascularisation involving the same limb within 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure.

- Patients having total occlusions of the iliac artery on the same side must be excluded.

- Previously implanted stent(s) in the to be treated artery at the same site.

- Requiring stent placement in the distal superficial femoral artery and the popliteal artery.

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
Smart Stent
Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
Luminexx Stent
Bard® Luminexx™ 6F Vascular Stent

Locations

Country Name City State
Germany Gemeinschaftspraxis füsar Radiologische Diagnostik& Zentrum für Minimal Invasite Therapie am Jüdischen Krankenhaus Berlin Berlin
Germany Universitat Leipzig Herzzentrum Abt. Für Klinische u. Intervent. Angiologie Leipzig

Sponsors (1)

Lead Sponsor Collaborator
Cordis Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary primary patency detectable by duplex ultrasound through the index lesion 12 months Yes
Secondary technical success time of deployment No
Secondary procedural success up to removal of catheter sheath No
Secondary procedural complications up to removal of catheter sheath Yes
Secondary Ankle Brachial Index discharge and 12 months Yes
Secondary primary patency 6 months Yes
Secondary binary restenosis 6 and 12 months Yes
Secondary stent fractures 6 and 12 months Yes
Secondary target lesion revascularisation 6 and 12 months Yes
Secondary target vessel revascularisation 6 and 12 months Yes
Secondary adverse events baseline, discharge, 6 and 12 months post procedure Yes
Secondary clinical categorization of chronic limb ischemia by means of the Rutherford classification discharge, 6 and 12 months post procedure Yes
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