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Not yet recruiting NCT07338890

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

— Observational Superficial Femoral Artery Stenosis Iliac Artery Stenosis Popliteal Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL ™ Nitinol Stent System, S.M.A.R.T.™ Flex Vascular Stent System.
Who it may be relevant to
Registry conditions: Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Popliteal Artery Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Post-Market Clinical Follow-Up Study of the S.M.A.R.T.™ Nitinol Stent System, S.M.A.R.T.™ CONTROL™ Nitinol Stent System and S.M.A.R.T. ™ Flex Vascular Stent System in the Treatment of Iliac and Femoropopliteal Artery Disease (REAL-SMART)

Overview

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.

Detailed description

The REAL-SMART study is a multi-center, non-randomized, observational analysis of retrospective data collected on all subjects treated with SMART 120/150, SMART CONTROL or SMART Flex. The purpose of this study is to evaluate long-term safety and performance per the intended use of the three (3) study devices. Each device constitutes a separate study arm and each arm is further stratified by indication, of which there are two per device. The study is conducted in approximately 20 sites located in approximately three (3) European countries with high volume use of one or more of the study devices. The enrollment and data collection take approximately 6-8 months.

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 femora

Primary outcome measures

  • Technical success of SMART 120/150 in patients with obstructive SFA disease [Time frame: At the conclusion of the index procedure]
  • Major amputation in patients treated with SMART 120/150 for obstructive SFA disease [Time frame: At 12 months post-index procedure]
  • Technical success of SMART 120/150 in patients with obstructive PPA disease [Time frame: At the conclusion of the index procedure]
  • Major amputation in patients treated with SMART 120/150 for obstructive PPA disease [Time frame: At 12 months post-index procedure]
  • Technical success of SMART CONTROL in patients with obstructive iliac artery disease [Time frame: At the conclusion of the index procedure]
  • Major amputation in patients with SMART CONTROL for obstructive iliac artery disease [Time frame: At 12 months post-index procedure]
  • Technical success of SMART CONTROL in patients with obstructive SFA disease [Time frame: At the conclusion of the index procedure]
  • Major amputation in patients treated with SMART CONTROL for obstructive SFA disease [Time frame: At 12 months post-index procedure]
  • Technical success of SMART Flex in patients with obstructive SFA disease [Time frame: At the conclusion of the index procedure]
  • Major amputation in patients treated with SMART Flex for obstructive SFA disease [Time frame: At 12 months post-index procedure]
Secondary outcome measures (12)
  • Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease [Time frame: At 12 months post-index procedure]
  • Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease [Time frame: At 12 months post-index procedure]
  • Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease [Time frame: At 12 months post-index procedure]
  • Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease [Time frame: At 12 months post-index procedure]
  • Patency at 12 months post-index procedure in patients treated with SMART Flex for obstructive SFA disease [Time frame: At 12 months post-index procedure]
  • Patency at 12 months post-index procedure in patients treated with SMART Flex for obstructive PPA disease [Time frame: At 12 months post-index procedure]
  • Target lesion restenosis in patients treated with SMART 120/150 for obstructive SFA disease [Time frame: At 12 months post-index procedure]
  • Target lesion restenosis in patients treated with SMART 120/150 for obstructive PPA disease [Time frame: At 12 months post-index procedure]
  • Target lesion restenosis in patients treated with SMART CONTROL for obstructive iliac artery disease [Time frame: At 12 months post-index procedure]
  • Target lesion restenosis in patients treated with SMART CONTROL for obstructive SFA disease [Time frame: At 12 months post-index procedure]
  • Target lesion restenosis in patients treated with SMART Flex for obstructive SFA disease [Time frame: At 12 months post-index procedure]
  • Target lesion restenosis in patients treated with SMART Flex for obstructive PPA disease [Time frame: At 12 months post-index procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital Clinico San Carlos — Madrid

Identifiers

NCT: NCT07338890 · P24-6202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗