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

N/ANot Yet RecruitingNCT07338890

Cordis US Corp.240 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Superficial Femoral Artery Stenosis Iliac Artery Stenosis Popliteal Artery Stenosis

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.

S.M.A.R.T.™ CONTROL ™ Nitinol Stent SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clinico San Carlos

Madrid, Spain

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

Kwame Ofori

CONTACT

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

Rajesh Nathan

CONTACT

rajesh.nathan@cordis.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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

Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis

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

Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis

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

Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis

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

Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis

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

Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis

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

Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis

Time frame: At 12 months post-index procedure

Target lesion restenosis in patients treated with SMART 120/150 for obstructive SFA disease

Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Target lesion restenosis in patients treated with SMART 120/150 for obstructive PPA disease

Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Target lesion restenosis in patients treated with SMART CONTROL for obstructive iliac artery disease

Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Target lesion restenosis in patients treated with SMART CONTROL for obstructive SFA disease

Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Target lesion restenosis in patients treated with SMART Flex for obstructive SFA disease

Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Target lesion restenosis in patients treated with SMART Flex for obstructive PPA disease

Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Procedural success in patients treated with SMART 120/150 for obstructive SFA disease

Procedural success, defined as successful stent deployment without occurrence of any procedural complications

Time frame: At the conclusion of the index procedure

Procedural success in patients treated with SMART 120/150 for obstructive PPA disease

Procedural success, defined as successful stent deployment without occurrence of any procedural complications

Time frame: At the conclusion of the index procedure

Procedural success in patients treated with SMART CONTROL for obstructive iliac artery disease

Procedural success, defined as successful stent deployment without occurrence of any procedural complications

Time frame: At the conclusion of the index procedure

Procedural success in patients treated with SMART CONTROL for obstructive SFA disease

Procedural success, defined as successful stent deployment without occurrence of any procedural complications

Time frame: At the conclusion of the index procedure

Procedural success in patients treated with SMART Flex for obstructive SFA disease

Procedural success, defined as successful stent deployment without occurrence of any procedural complications

Time frame: At the conclusion of the index procedure

Procedural success in patients treated with SMART Flex for obstructive PPA disease

Procedural success, defined as successful stent deployment without occurrence of any procedural complications

Time frame: At the conclusion of the index procedure

Target Lesion Revascularization in patients treated with SMART 120/150 for obstructive SFA disease

Target Lesion Revascularization through 12 months post-index procedure

Time frame: Through 12 months post-index procedure

Target Lesion Revascularization in patients treated with SMART 120/150 for obstructive PPA disease

Target Lesion Revascularization through 12 months post-index procedure

Time frame: Through 12 months post-index procedure

Target Lesion Revascularization in patients treated with SMART CONTROL for obstructive iliac artery disease

Target Lesion Revascularization through 12 months post-index procedure

Time frame: Through 12 months post-index procedure

Target Lesion Revascularization in patients treated with SMART CONTROL for obstructive SFA disease

Target Lesion Revascularization through 12 months post-index procedure

Time frame: Through 12 months post-index procedure

Target Lesion Revascularization in patients treated with SMART Flex for obstructive SFA disease

Target Lesion Revascularization through 12 months post-index procedure

Time frame: Through 12 months post-index procedure

Target Lesion Revascularization in patients treated with SMART Flex for obstructive PPA disease

Target Lesion Revascularization through 12 months post-index procedure

Time frame: Through 12 months post-index procedure

All-Cause Mortality through 30 days post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease

All-Cause Mortality through 30 days post-index procedure

Time frame: Through 30 days post-index procedure

All-Cause Mortality through 30 days post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease

All-Cause Mortality through 30 days post-index procedure

Time frame: Through 30 days post-index procedure

All-Cause Mortality through 30 days post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease

All-Cause Mortality through 30 days post-index procedure

Time frame: Through 30 days post-index procedure

All-Cause Mortality through 30 days post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease

All-Cause Mortality through 30 days post-index procedure

Time frame: Through 30 days post-index procedure

All-Cause Mortality through 30 days post-index procedure in patients treated with SMART Flex for obstructive SFA disease

All-Cause Mortality through 30 days post-index procedure

Time frame: Through 30 days post-index procedure

All-Cause Mortality through 30 days post-index procedure in patients treated with SMART Flex for obstructive PPA disease

All-Cause Mortality through 30 days post-index procedure

Time frame: Through 30 days post-index procedure

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure in patients treated with SMART Flex for obstructive SFA disease

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure in patients treated with SMART Flex for obstructive PPA disease

Rate of serious adverse events (SAE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure in patients treated with SMART Flex for obstructive SFA disease

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure in patients treated with SMART Flex for obstructive PPA disease

Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure in patients treated with SMART Flex for obstructive SFA disease

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure in patients treated with SMART Flex for obstructive PPA disease

Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure

Time frame: Through 36 months (3 years) post-index procedure

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure in patients treated with SMART Flex for obstructive SFA disease

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure in patients treated with SMART Flex for obstructive PPA disease

Rate of serious adverse device effects (SADE) through 60 months (5 years) post-index procedure

Time frame: Through 60 months (5 years) post-index procedure

Rate of stent fractures by type at 6 months post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease

Rate of stent fractures at 6 months post-index procedure

Time frame: At 6 months post-index procedure

Rate of stent fractures by type at 6 months post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease

Rate of stent fractures at 6 months post-index procedure

Time frame: At 6 months post-index procedure

Rate of stent fractures by type at 6 months post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease

Rate of stent fractures at 6 months post-index procedure

Time frame: At 6 months post-index procedure

Rate of stent fractures by type at 6 months post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease

Rate of stent fractures at 6 months post-index procedure

Time frame: At 6 months post-index procedure

Rate of stent fractures at 6 months by type post-index procedure in patients treated with SMART Flex for obstructive SFA disease

Rate of stent fractures at 6 months post-index procedure

Time frame: At 6 months post-index procedure

Rate of stent fractures at 6 months by type post-index procedure in patients treated with SMART Flex for obstructive PPA disease

Rate of stent fractures at 6 months post-index procedure

Time frame: At 6 months post-index procedure

Rate of stent fractures at 12 months by type post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease

Rate of stent fractures at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Rate of stent fractures at 12 months by type post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease

Rate of stent fractures at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Rate of stent fractures at 12 months by type post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease

Rate of stent fractures at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Rate of stent fractures at 12 months by type post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease

Rate of stent fractures at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Rate of stent fractures at 12 months by type post-index procedure in patients treated with SMART Flex for obstructive SFA disease

Rate of stent fractures at 12 months post-index procedure

Time frame: At 12 months post-index procedure

Rate of stent fractures at 12 months by type post-index procedure in patients treated with SMART Flex for obstructive PPA disease

Rate of stent fractures at 12 months post-index procedure

Time frame: At 12 months post-index procedure