CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
S.M.A.R.T. ® Stentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00739102
NCT00739102N/ACompleted
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S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL)

Cordis US Corp.·interventional·Posted Aug 21, 2008·Updated Apr 17, 2014

In Brief

A clinical study evaluating S.M.A.R.T. ® Stent for Superficial Femoral Artery Disease. Completed, enrolled 250 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuperficial Femoral Artery Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 21, 2008
Enrollment StartAug 1, 2008
Primary CompletionMay 1, 2011
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.9 years ago

Interventions

S.M.A.R.T. ® Stentdevice

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.