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The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent (SUPER SL)

C

Cordis

Status and phase

Completed
Phase 4

Conditions

Arterial Occlusive Diseases

Treatments

Device: Luminexx Stent
Device: Smart Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00235131
EE04-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

1
Experimental group
Description:
Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
Treatment:
Device: Smart Stent
2
Active Comparator group
Description:
Bard® Luminexx™ 6F Vascular Stent
Treatment:
Device: Luminexx Stent

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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