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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

NCT07338890 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2026-01-14

No results posted yet for this 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.

Conditions

  • Superficial Femoral Artery Stenosis
  • Iliac Artery Stenosis
  • Popliteal Artery Stenosis

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Rede Optimus Hospitalar SA

    collaborator NETWORK

  • Cordis US Corp.

    lead INDUSTRY

Principal Investigators

  • Nusrath Sultana · Cordis US Corp.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-05-30
Completion
2026-05-30
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07338890 on ClinicalTrials.gov