A Study of the SMART Stent in the Treatment SFA Disease. (SIROCCO)

The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery (SFA) disease in reducing percent in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to the uncoated SMART™ stent.

This is a multi-center, prospective, randomized, double blind, two-arm feasibility study evaluating the safety and performance of the sirolimus coated Cordis SMART™ nitinol self-expanding stent and delivery system as compared to the uncoated SMART™ stent and delivery system. It is anticipated that a total of 90 patients will be entered into the study. Patients will be randomized on a 1:1 basis of coated to uncoated stents.

Ninety (90) patients with de novo or restenotic native SFA lesions will be randomized to the Sirolimus Coated SMART™ nitinol self-expanding stent or to the uncoated (bare) SMART™ stent.

Patients will be followed for 24 months post-procedure, with all patients having duplex ultrasound and clinical assessments at discharge, 1, 6, 9, 18 and 24 months, angiography at 6 six months and plain X-ray at 18 months. This study will be conducted at nine investigational sites. (Protocol was amended where 56 additional patients were recruited and followed for up to 5 years.)

• Device: drug-eluting stent
  Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
• Device: bare-metal stent
  SMART™ bare-metal stent

• Experimental: 1
  Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
  Intervention: Device: drug-eluting stent
• Active Comparator: 2
  SMART™ bare-metal stent
  Intervention: Device: bare-metal stent

Inclusion Criteria:

1. One superficial femoral artery presenting > 70% stenosis(es) or total occlusion
2. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4)

Exclusion Criteria:

1. Tissue loss due to ischemic disease (Rutherford category 5 or 6).
2. Tandem lesion requiring non overlapping stents;