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Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease

Sponsored by Cordis US Corp.

About this trial

Last updated 3 months ago

Study ID

P24-6202

Status

Not yet recruiting

Type

Observational

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Started 3 months ago

What is this trial about?

The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™ Flex Vascular Stent System (SMART Flex) in the treatment of iliac and femoropopliteal artery disease.

What are the Participation Requirements?

Inclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to include in the study: * Subjects treated with SMART 120/150, SMART CONTROL or SMART Flex according to the respective Instructions for Use for treatment in the iliac, superficial femoral and/or proximal popliteal arteries. * If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment/procedure or until time of death, whichever came first. It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment/procedure or until time of death, whichever came first. Subjects not included because follow-up information is unavailable will be documented, wherever possible, with respect to demographics and presenting disease state to determine whether they are similar to subjects with follow-up that are enrolled. Exclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to exclude in the study: * Women who were pregnant or lactating at the time of the procedure. * Pediatric subjects (<18 years of age) at the time of the procedure.