Clinical trial NCT00235131: The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent
Official title: A Clinical Investigation of the Cordis S.M.A.R.T. ™ CONTROL ™ Nitinol Stent System Versus the Bard® Luminexx™ 6F Vascular Stent for the Treatment of TASC C & D Superficial Femoral Artery Long Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arterial Occlusive Diseases
Keywords: Peripheral Artery Occlusive Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: primary patency detectable by duplex ultrasound through the index lesion
timeFrame: 12 months
Secondary outcomes:
measure: technical success
timeFrame: time of deployment
measure: procedural success
timeFrame: up to removal of catheter sheath
measure: procedural complications
timeFrame: up to removal of catheter sheath
measure: Ankle Brachial Index
timeFrame: discharge and 12 months
measure: primary patency
timeFrame: 6 months
measure: binary restenosis
timeFrame: 6 and 12 months
measure: stent fractures
timeFrame: 6 and 12 months
measure: target lesion revascularisation
timeFrame: 6 and 12 months
measure: target vessel revascularisation
timeFrame: 6 and 12 months
measure: adverse events
timeFrame: baseline, discharge, 6 and 12 months post procedure
measure: clinical categorization of chronic limb ischemia by means of the Rutherford classification
timeFrame: discharge, 6 and 12 months post procedure
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Gemeinschaftspraxis füsar Radiologische Diagnostik& Zentrum für Minimal Invasite Therapie am Jüdischen Krankenhaus Berlin
city: Leipzig
country: Germany
facility: Universitat Leipzig Herzzentrum Abt. Für Klinische u. Intervent. Angiologie
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Dierk Schneinert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gemeinschaftspraxis füsar Radiologische
name: Stephan Duda, MD
role: PRINCIPAL_INVESTIGATOR
References: