Iliac Artery Stenosis, Popliteal Artery Stenosis, Superficial Femoral Artery Stenosis
Conditions
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
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.
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
DEVICES.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.
DEVICES.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.
DEVICES.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
Rede Optimus Hospitalar SA
Cordis US Corp.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success in patients treated with SMART 120/150 for obstructive SFA disease | At the conclusion of the index procedure | Procedural success, defined as successful stent deployment without occurrence of any procedural complications |
| Procedural success in patients treated with SMART 120/150 for obstructive PPA disease | At the conclusion of the index procedure | Procedural success, defined as successful stent deployment without occurrence of any procedural complications |
| Procedural success in patients treated with SMART CONTROL for obstructive iliac artery disease | At the conclusion of the index procedure | Procedural success, defined as successful stent deployment without occurrence of any procedural complications |
| Procedural success in patients treated with SMART CONTROL for obstructive SFA disease | At the conclusion of the index procedure | Procedural success, defined as successful stent deployment without occurrence of any procedural complications |
| Procedural success in patients treated with SMART Flex for obstructive SFA disease | At the conclusion of the index procedure | Procedural success, defined as successful stent deployment without occurrence of any procedural complications |
| Procedural success in patients treated with SMART Flex for obstructive PPA disease | At the conclusion of the index procedure | Procedural success, defined as successful stent deployment without occurrence of any procedural complications |
| Target Lesion Revascularization in patients treated with SMART 120/150 for obstructive SFA disease | Through 12 months post-index procedure | Target Lesion Revascularization through 12 months post-index procedure |
| Target Lesion Revascularization in patients treated with SMART 120/150 for obstructive PPA disease | Through 12 months post-index procedure | Target Lesion Revascularization through 12 months post-index procedure |
| Target Lesion Revascularization in patients treated with SMART CONTROL for obstructive iliac artery disease | Through 12 months post-index procedure | Target Lesion Revascularization through 12 months post-index procedure |
| Target Lesion Revascularization in patients treated with SMART CONTROL for obstructive SFA disease | Through 12 months post-index procedure | Target Lesion Revascularization through 12 months post-index procedure |
| Target Lesion Revascularization in patients treated with SMART Flex for obstructive SFA disease | Through 12 months post-index procedure | Target Lesion Revascularization through 12 months post-index procedure |
| Target Lesion Revascularization in patients treated with SMART Flex for obstructive PPA disease | Through 12 months post-index procedure | Target Lesion Revascularization 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 | Through 30 days post-index procedure | All-Cause Mortality 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 | Through 30 days post-index procedure | All-Cause Mortality 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 | Through 30 days post-index procedure | All-Cause Mortality 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 | Through 30 days post-index procedure | All-Cause Mortality 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 | Through 30 days post-index procedure | All-Cause Mortality 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 | Through 30 days post-index procedure | All-Cause Mortality 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse events (SAE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | Through 36 months (3 years) post-index procedure | Rate of serious adverse device effects (SADE) through 36 months (3 years) post-index procedure |
| 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, defined as achievement of less than or equal to (≤) 50% diameter stenosis |
| 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse device effects (SADE) 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 | At 6 months post-index procedure | Rate of stent fractures 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 | At 6 months post-index procedure | Rate of stent fractures 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 | At 6 months post-index procedure | Rate of stent fractures 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 | At 6 months post-index procedure | Rate of stent fractures 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 | At 6 months post-index procedure | Rate of stent fractures 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 | At 6 months post-index procedure | Rate of stent fractures 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 | At 12 months post-index procedure | Rate of stent fractures 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 | At 12 months post-index procedure | Rate of stent fractures 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 | At 12 months post-index procedure | Rate of stent fractures 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 | At 12 months post-index procedure | Rate of stent fractures 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 | At 12 months post-index procedure | Rate of stent fractures 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 | At 12 months post-index procedure | Rate of stent fractures at 12 months 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 | Through 60 months (5 years) post-index procedure | Rate of serious adverse device effects (SADE) through 60 months (5 years) 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, defined as achievement of less than or equal to (≤) 50% diameter stenosis |
| 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, defined as achievement of less than or equal to (≤) 50% diameter stenosis |
| 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, defined as achievement of less than or equal to (≤) 50% diameter stenosis |
| Patency at 12 months post-index procedure in patients treated with SMART Flex for obstructive SFA disease | At 12 months post-index procedure | Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis |
| Patency at 12 months post-index procedure in patients treated with SMART Flex for obstructive PPA disease | At 12 months post-index procedure | Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis |
| Target lesion restenosis in patients treated with SMART 120/150 for obstructive SFA disease | At 12 months post-index procedure | Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure |
| Target lesion restenosis in patients treated with SMART 120/150 for obstructive PPA disease | At 12 months post-index procedure | Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure |
| Target lesion restenosis in patients treated with SMART CONTROL for obstructive iliac artery disease | At 12 months post-index procedure | Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure |
| Target lesion restenosis in patients treated with SMART CONTROL for obstructive SFA disease | At 12 months post-index procedure | Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure |
| Target lesion restenosis in patients treated with SMART Flex for obstructive SFA disease | At 12 months post-index procedure | Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure |
| Target lesion restenosis in patients treated with SMART Flex for obstructive PPA disease | At 12 months post-index procedure | Target lesion restenosis, defined as greater than (\>) 50% diameter stenosis at 12 months post-index procedure |
Countries
Spain
Contacts
Primary ContactKwame Ofori
Backup ContactRajesh Nathan
Outcome results
None listed