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

NCT07338890 · tracked via the Priya Life Science Spain tracker

Sponsor

Cordis US Corp

Phase

Observational

Started

2026-01-31

Last updated

2026-01-14

Condition(s) studied

Superficial Femoral Artery StenosisIliac Artery StenosisPopliteal Artery Stenosis

Investigational drug(s) / intervention(s)

S.M.A.R.T.™ Nitinol Stent System (SMART 120/150)S.M.A.R.T.™ CONTROL ™ Nitinol Stent SystemS.M.A.R.T.™ Flex Vascular Stent System

S.M.A.R.T.™ Nitinol Stent System (SMART 120/150): The Cordis S.M.A.R.T.™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the peripheral vasculature via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery and proximal popliteal artery.

S.M.A.R.T.™ CONTROL ™ Nitinol Stent System: The Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the iliac and/or superficial femoral arteries via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ CONTROL™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of iliac and/or superficial femoral arteries.

S.M.A.R.T.™ Flex Vascular Stent System: The Cordis S.M.A.R.T.™ Flex Stent is a single-use device consisting of an endovascular stent and sheath delivery system, intended to deliver a self-expanding endovascular stent to the superficial femoral artery (SFA). The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T.™ Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and/or occlusive diseases in the superficial femoral artery and proximal popliteal artery.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Technical success of SMART 120/150 in patients with obstructive SFA disease — At the conclusion of the index procedure
Technical success, defined as achievement of a final diameter stenosis of less than or equal to (≤) 30% residual stenosis at the conclusion of the index procedure
Major amputation in patients treated with SMART 120/150 for obstructive SFA disease — At 12 months post-index procedure
Major amputation at 12 months post-index procedure
Technical success of SMART 120/150 in patients with obstructive PPA disease — At the conclusion of the index procedure
Technical success, defined as achievement of a final diameter stenosis of less than or equal to (≤) 30% residual stenosis at the conclusion of the index procedure
Major amputation in patients treated with SMART 120/150 for obstructive PPA disease — At 12 months post-index procedure
Major amputation at 12 months post-index procedure
Technical success of SMART CONTROL in patients with obstructive iliac artery disease — At the conclusion of the index procedure
Technical success, defined as achievement of a final diameter stenosis of less than or equal to (≤) 30% residual stenosis at the conclusion of the index procedure
Major amputation in patients with SMART CONTROL for obstructive iliac artery disease — At 12 months post-index procedure
Major amputation at 12 months post-index procedure
Technical success of SMART CONTROL in patients with obstructive SFA disease — At the conclusion of the index procedure
Technical success, defined as achievement of a final diameter stenosis of less than or equal to (≤) 30% residual stenosis at the conclusion of the index procedure
Major amputation in patients treated with SMART CONTROL for obstructive SFA disease — At 12 months post-index procedure
Major amputation at 12 months post-index procedure
Technical success of SMART Flex in patients with obstructive SFA disease — At the conclusion of the index procedure
Technical success, defined as achievement of a final diameter stenosis of less than or equal to (≤) 30% residual stenosis at the conclusion of the index procedure
Major amputation in patients treated with SMART Flex for obstructive SFA disease — At 12 months post-index procedure
Major amputation at 12 months post-index procedure
Technical success of SMART Flex in patients with obstructive PPA disease — At the conclusion of the index procedure
Technical success, defined as achievement of a final diameter stenosis of less than or equal to (≤) 30% residual stenosis at the conclusion of the index procedure
Major amputation in patients treated with SMART Flex for obstructive PPA disease — At 12 months post-index procedure
Major amputation at 12 months post-index procedure

Trial sites (1)

Facility	City	Region	Status
Hospital Clinico San Carlos	Madrid	Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07338890 on ClinicalTrials.gov ↗ ← All trials in Spain