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| Name | Class |
|---|---|
| Rede Optimus Hospitalar SA | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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. |
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| 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). |
| |
| Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART Flex. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 12 months post-index procedure |
| Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease |
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Inclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to include in the study:
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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kwame Ofori | Contact | 832-407-3326 | kwame.ofori@cordis.com | |
| Rajesh Nathan | Contact | rajesh.nathan@cordis.com |
| Name | Affiliation | Role |
|---|---|---|
| Nusrath Sultana | Cordis US Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
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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). |
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| 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). |
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| 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. |
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| 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. |
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| 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 |
Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At 12 months post-index procedure |