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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Technical success of SMART 120/150 in patients with obstructive SFA disease
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150) (Device)
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).
干预措施: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150) (Device)
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.
干预措施: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System (Device)
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).
干预措施: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System (Device)
Subjects with stenotic lesions of the superficial femoral artery (SFA) 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 superficial femoral artery (SFA).
干预措施: S.M.A.R.T.™ Flex Vascular Stent System (Device)
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).
干预措施: S.M.A.R.T.™ Flex Vascular Stent System (Device)
结局指标
主要结局
Technical success of SMART 120/150 in patients with obstructive SFA disease
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: At 12 months post-index procedure
Major amputation at 12 months post-index procedure
次要结局
- 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 in patients treated with SMART 120/150 for obstructive PPA disease(At 12 months post-index procedure)
- 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 in patients treated with SMART CONTROL for obstructive SFA disease(At 12 months post-index procedure)
- 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 in patients treated with SMART Flex for obstructive PPA disease(At 12 months post-index procedure)
- Target lesion restenosis in patients treated with SMART 120/150 for obstructive SFA disease(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 in patients treated with SMART CONTROL for obstructive iliac artery disease(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 in patients treated with SMART Flex for obstructive SFA disease(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)
- Procedural success in patients treated with SMART 120/150 for obstructive SFA disease(At the conclusion of the index procedure)
- Procedural success in patients treated with SMART 120/150 for obstructive PPA disease(At the conclusion of the index procedure)
- Procedural success in patients treated with SMART CONTROL for obstructive iliac artery disease(At the conclusion of the index procedure)
- Procedural success in patients treated with SMART CONTROL for obstructive SFA disease(At the conclusion of the index procedure)
- Procedural success in patients treated with SMART Flex for obstructive SFA disease(At the conclusion of the index procedure)
- Procedural success in patients treated with SMART Flex for obstructive PPA disease(At the conclusion of the index procedure)
- Target Lesion Revascularization in patients treated with SMART 120/150 for obstructive SFA disease(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 in patients treated with SMART CONTROL for obstructive iliac artery disease(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 in patients treated with SMART Flex for obstructive SFA disease(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)
- 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 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 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 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 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 in patients treated with SMART Flex for obstructive PPA disease(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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 in patients treated with SMART Flex for obstructive PPA disease(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 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 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 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 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 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 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 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 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 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 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 by type post-index procedure in patients treated with SMART Flex for obstructive PPA disease(At 12 months post-index procedure)