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

NCT07338890 | Not Yet Recruiting FDA Device

• 1 other identifier: P24-6202
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Superficial Femoral Artery Stenosis; Iliac Artery Stenosis; Popliteal Artery Stenosis

Keywords

Superficial Femoral Artery Stenosis; Iliac Artery Stenosis; Popliteal Artery Stenosis; SMART CONTROL Nitinol Stent System; SMART FLEX Vascular Stent System; SMART Nitinol Stent System; SFA Stenosis; PPA Stenosis

Outcome Measures

Primary Outcomes (12)

• Technical success of SMART 120/150 in patients with obstructive SFA disease

  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

  At the conclusion of the index procedure

• Major amputation in patients treated with SMART 120/150 for obstructive SFA disease

  Major amputation at 12 months post-index procedure

  At 12 months post-index procedure

• Technical success of SMART 120/150 in patients with obstructive PPA disease

  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

  At the conclusion of the index procedure

• Major amputation in patients treated with SMART 120/150 for obstructive PPA disease

  Major amputation at 12 months post-index procedure

  At 12 months post-index procedure

• Technical success of SMART CONTROL in patients with obstructive iliac artery disease

  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

  At the conclusion of the index procedure

• Major amputation in patients with SMART CONTROL for obstructive iliac artery disease

  Major amputation at 12 months post-index procedure

  At 12 months post-index procedure

• Technical success of SMART CONTROL in patients with obstructive SFA disease

  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

  At the conclusion of the index procedure

• Major amputation in patients treated with SMART CONTROL for obstructive SFA disease

  Major amputation at 12 months post-index procedure

  At 12 months post-index procedure

• Technical success of SMART Flex in patients with obstructive SFA disease

  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

  At the conclusion of the index procedure

• Major amputation in patients treated with SMART Flex for obstructive SFA disease

  Major amputation at 12 months post-index procedure

  At 12 months post-index procedure

• Technical success of SMART Flex in patients with obstructive PPA disease

  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

  At the conclusion of the index procedure

• Major amputation in patients treated with SMART Flex for obstructive PPA disease

  Major amputation at 12 months post-index procedure

  At 12 months post-index procedure

Secondary Outcomes (66)

• Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease

  At 12 months post-index procedure

• Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease

  At 12 months post-index procedure

• Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease

  At 12 months post-index procedure

• Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease

  At 12 months post-index procedure

• Patency at 12 months post-index procedure in patients treated with SMART Flex for obstructive SFA disease

  At 12 months post-index procedure

Study Arms (6)

Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART 120/150.

The Cordis S.M.A.R.T.TM Nitinol Stent System (SMART 120/150) is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery (SFA).

Device: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150)

Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART 120/150.

The Cordis S.M.A.R.T.TM Nitinol Stent System (SMART 120/150) is indicated in enabling treatment in patients with atherosclerotic disease of the proximal popliteal artery (PPA).

Device: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150)

Subjects with stenotic lesions of the iliac artery treated with SMART CONTROL.

The Cordis S.M.A.R.T.TM CONTROLTM Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the iliac artery.

Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System

Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART CONTROL.

The Cordis S.M.A.R.T.TM CONTROLTM Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery (SFA).

Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System

Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART Flex.

The Cordis S.M.A.R.T.TM Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and/or occlusive diseases in the superficial femoral artery (SFA).

Device: S.M.A.R.T.™ Flex Vascular Stent System

Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART Flex.

The Cordis S.M.A.R.T.TM Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and/or occlusive diseases in the proximal popliteal artery (PPA).

Device: S.M.A.R.T.™ Flex Vascular Stent System

Interventions

S.M.A.R.T.™ Nitinol Stent System (SMART 120/150) DEVICE

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.

Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART 120/150.; Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART 120/150.

S.M.A.R.T.™ CONTROL ™ Nitinol Stent System DEVICE

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.

Subjects with stenotic lesions of the iliac artery treated with SMART CONTROL.; Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART CONTROL.

S.M.A.R.T.™ Flex Vascular Stent System DEVICE

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.

Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART Flex.; Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART Flex.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects to be included in this study are those treated with SMART 120/150, SMART CONTROL or SMART Flex, according to the respective Instructions for Use, for stenosis in the iliac, superficial femoral and/or proximal popliteal arteries. Approximately 20 sites located in approximately three (3) European countries with high volume use of one or more of the study products will participate.

You may qualify if:

• 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.

You may not qualify if:

• Women who were pregnant or lactating at the time of the procedure.
• Pediatric subjects (\<18 years of age) at the time of the procedure.

Sponsors & Collaborators

• Cordis US Corp.: lead
• Rede Optimus Hospitalar SA: collaborator

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Study Officials

• Nusrath Sultana

  Cordis US Corp.

  STUDY DIRECTOR

Central Study Contacts

Kwame Ofori

CONTACT

832-407-3326; kwame.ofori@cordis.com

Rajesh Nathan

CONTACT

rajesh.nathan@cordis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

ES (1)