Superficial Femoral Artery StenosisREAL-SMARTNCT07338890
Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease
An observational study of Superficial Femoral Artery Stenosis and Iliac Artery Stenosis, run by Cordis US Corp. at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Popliteal Artery Stenosis
- What is being tested?
- S.M.A.R.T.™ Nitinol Stent System (SMART 120/150) and S.M.A.R.T.™ Flex Vascular Stent System
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2026to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rajesh Nathan contact
Spain1 site
Hospital Clinico San Carlos
Madrid, 28040
Martin Lagos, Prof
Isaac M Lopez, MD
About this study
Official title: Post-Market Clinical Follow-Up Study of the S.M.A.R.T.™ Nitinol Stent System, S.M.A.R.T.™ CONTROL™ Nitinol Stent System and S.M.A.R.T. ™ Flex Vascular Stent System in the Treatment of Iliac and Femoropopliteal Artery Disease (REAL-SMART)
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.
Read the 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.
- Being tested
- S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL ™ Nitinol Stent System, S.M.A.R.T.™ Flex Vascular Stent System
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
S.M.A.R.T.™ Flex Vascular Stent SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150) | |
| 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). Receives: Device: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150) | |
| 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. Receives: Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System | |
| 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). Receives: Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System | |
| 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). Receives: Device: S.M.A.R.T.™ Flex Vascular Stent System | |
| 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). Receives: Device: S.M.A.R.T.™ Flex Vascular Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 12 months post-index procedure
Secondary outcomes (66)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 12 months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Femoral Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rede Optimus Hospitalar SA
- Responsible party
- Sponsor
- Investigators
- Nusrath Sultana, Study director, Cordis US Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338890
- Sponsor's protocol ID
- P24-6202
- Acronym
- REAL-SMART
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up Study of the S.M.A.R.T.™ Nitinol Stent System, S.M.A.R.T.™ CONTROL™ Nitinol Stent System and S.M.A.R.T. ™ Flex Vascular Stent System in the Treatment of Iliac and Femoropopliteal Artery Disease (REAL-SMART)
- ClinicalTrials.gov ID
- NCT07338890
- Acronym / sponsor ID
- REAL-SMART / P24-6202
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Collaborators
- Rede Optimus Hospitalar SA
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART 120/150. | – | Device: S.M.A.R.T.™ Nitinol Stent System (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). |
| Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART 120/150. | – | Device: S.M.A.R.T.™ Nitinol Stent System (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). |
| Subjects with stenotic lesions of the iliac artery treated with SMART CONTROL. | – | Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent SystemThe 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. |
| Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART CONTROL. | – | Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent SystemThe 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. | – | Device: S.M.A.R.T.™ Flex Vascular Stent SystemThe 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). |
| Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART Flex. | – | Device: S.M.A.R.T.™ Flex Vascular Stent SystemThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S.M.A.R.T.™ Nitinol Stent System (SMART 120/150)The Cordis S.M.A.R.T.™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the peripheral vasculature via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery and proximal popliteal artery. | Device | Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART 120/150., Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART 120/150. |
| S.M.A.R.T.™ CONTROL ™ Nitinol Stent SystemThe Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the iliac and/or superficial femoral arteries via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ CONTROL™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of iliac and/or superficial femoral arteries. | Device | Subjects with stenotic lesions of the iliac artery treated with SMART CONTROL., Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART CONTROL. |
| S.M.A.R.T.™ Flex Vascular Stent SystemThe 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. | Device | Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART Flex., Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART Flex. |
Primary outcome
Technical success of SMART 120/150 in patients with obstructive SFA disease
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 12 months post-index procedure
Major amputation at 12 months post-index procedure
66 secondary outcomes
Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease
Time frame: At 12 months post-index procedure
Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease
Time frame: At 12 months post-index procedure
Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease
Time frame: At 12 months post-index procedure
Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease
Time frame: At 12 months post-index procedure
Patency at 12 months post-index procedure in patients treated with SMART Flex for obstructive SFA disease
Time frame: At 12 months post-index procedure
Patency at 12 months post-index procedure in patients treated with SMART Flex for obstructive PPA disease
Time frame: At 12 months post-index procedure
Target lesion restenosis in patients treated with SMART 120/150 for obstructive SFA disease
Time frame: At 12 months post-index procedure
Target lesion restenosis in patients treated with SMART 120/150 for obstructive PPA disease
Time frame: At 12 months post-index procedure
Target lesion restenosis in patients treated with SMART CONTROL for obstructive iliac artery disease
Time frame: At 12 months post-index procedure
Target lesion restenosis in patients treated with SMART CONTROL for obstructive SFA disease
Time frame: At 12 months post-index procedure
Target lesion restenosis in patients treated with SMART Flex for obstructive SFA disease
Time frame: At 12 months post-index procedure
Target lesion restenosis in patients treated with SMART Flex for obstructive PPA disease
Time frame: At 12 months post-index procedure
Procedural success in patients treated with SMART 120/150 for obstructive SFA disease
Time frame: At the conclusion of the index procedure
Procedural success in patients treated with SMART 120/150 for obstructive PPA disease
Time frame: At the conclusion of the index procedure
Procedural success in patients treated with SMART CONTROL for obstructive iliac artery disease
Time frame: At the conclusion of the index procedure
Procedural success in patients treated with SMART CONTROL for obstructive SFA disease
Time frame: At the conclusion of the index procedure
Procedural success in patients treated with SMART Flex for obstructive SFA disease
Time frame: At the conclusion of the index procedure
Procedural success in patients treated with SMART Flex for obstructive PPA disease
Time frame: At the conclusion of the index procedure
Target Lesion Revascularization in patients treated with SMART 120/150 for obstructive SFA disease
Time frame: Through 12 months post-index procedure
Target Lesion Revascularization in patients treated with SMART 120/150 for obstructive PPA disease
Time frame: Through 12 months post-index procedure
Target Lesion Revascularization in patients treated with SMART CONTROL for obstructive iliac artery disease
Time frame: Through 12 months post-index procedure
Target Lesion Revascularization in patients treated with SMART CONTROL for obstructive SFA disease
Time frame: Through 12 months post-index procedure
Target Lesion Revascularization in patients treated with SMART Flex for obstructive SFA disease
Time frame: Through 12 months post-index procedure
Target Lesion Revascularization in patients treated with SMART Flex for obstructive PPA disease
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Through 60 months (5 years) post-index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajesh Nathan contact
Nusrath Sultana study director
Cordis US Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Femoral Artery Stenosis and Iliac Artery Stenosis, run by Cordis US Corp. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kwame Ofori (832-407-3326, kwame.ofori@cordis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of SMART 120/150 in patients with obstructive SFA disease (time frame: At the conclusion of the index procedure). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.