NCT00739102

S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease

S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, non-randomized, single-arm, prospective trial evaluating the safety and effectiveness of the S.M.A.R.T.™ Nitinol Stent System implantation in approximately 250 patients with obstructive superficial femoral artery disease.

Conditions

• Superficial Femoral Artery Disease

Interventions

Type	Name	Description
DEVICE	S.M.A.R.T. ® Stent	The Cordis S.M.A.R.T.® Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-05-01
• Completion: 2013-04-01
• First posted: 2008-08-21
• Last updated: 2014-04-17
• Results posted: 2013-09-18

Locations

1 site across 1 country: United States