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NCT Number: NCT07338890

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

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.

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Key information

Conditions

Superficial Femoral Artery Stenosis Iliac Artery Stenosis Popliteal Artery Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location contact

Isaac M Lopez, MD

PRINCIPAL_INVESTIGATOR

Martin Lagos, Prof

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Secondary outcomes

  1. 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, defined as achievement of less than or equal to (≤) 50% diameter stenosis

  2. 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, defined as achievement of less than or equal to (≤) 50% diameter stenosis

  3. 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, defined as achievement of less than or equal to (≤) 50% diameter stenosis

  4. 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, defined as achievement of less than or equal to (≤) 50% diameter stenosis

  5. 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, defined as achievement of less than or equal to (≤) 50% diameter stenosis

  6. 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

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

  7. 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, defined as greater than (>) 50% diameter stenosis at 12 months post-index procedure

  8. 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, defined as greater than (>) 50% diameter stenosis at 12 months post-index procedure

  9. 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, defined as greater than (>) 50% diameter stenosis at 12 months post-index procedure

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

    Time frame: At 12 months post-index procedure

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

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

    Time frame: At 12 months post-index procedure

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

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

    Time frame: At 12 months post-index procedure

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

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

    Time frame: At the conclusion of the index procedure

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

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

    Time frame: At the conclusion of the index procedure

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

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

    Time frame: At the conclusion of the index procedure

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

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

    Time frame: At the conclusion of the index procedure

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

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

    Time frame: At the conclusion of the index procedure

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

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

    Time frame: At the conclusion of the index procedure

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

  19. 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 through 12 months post-index procedure

  20. 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 through 12 months post-index procedure

  21. 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 through 12 months post-index procedure

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

    Time frame: Through 12 months post-index procedure

    Target Lesion Revascularization through 12 months post-index procedure

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

    Time frame: Through 12 months post-index procedure

    Target Lesion Revascularization through 12 months post-index procedure

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

    Time frame: Through 12 months post-index procedure

    Target Lesion Revascularization through 12 months post-index procedure

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

    All-Cause Mortality through 30 days post-index procedure

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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 36 months (3 years) post-index procedure

  37. 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

  38. 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

  39. 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

  40. 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

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

  41. Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure in patients treated with SMART Flex 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

  42. Rate of serious adverse events (SAE) through 60 months (5 years) post-index procedure in patients treated with SMART Flex 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

  43. 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

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

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

  44. 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

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

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

  45. 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

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

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

  46. 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

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

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

  47. 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

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

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

  48. 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

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

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

  49. 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

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

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

  50. 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

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

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

  51. 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

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

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

  52. 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

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

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

  53. 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

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

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

  54. 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

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

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

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

    Time frame: At 6 months post-index procedure

    Rate of stent fractures at 6 months post-index procedure

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

    Time frame: At 6 months post-index procedure

    Rate of stent fractures at 6 months post-index procedure

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

    Time frame: At 6 months post-index procedure

    Rate of stent fractures at 6 months post-index procedure

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

    Time frame: At 6 months post-index procedure

    Rate of stent fractures at 6 months post-index procedure

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

    Time frame: At 6 months post-index procedure

    Rate of stent fractures at 6 months post-index procedure

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

    Time frame: At 6 months post-index procedure

    Rate of stent fractures at 6 months post-index procedure

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

    Time frame: At 12 months post-index procedure

    Rate of stent fractures at 12 months post-index procedure

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

    Time frame: At 12 months post-index procedure

    Rate of stent fractures at 12 months post-index procedure

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

    Time frame: At 12 months post-index procedure

    Rate of stent fractures at 12 months post-index procedure

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

    Time frame: At 12 months post-index procedure

    Rate of stent fractures at 12 months post-index procedure

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

    Time frame: At 12 months post-index procedure

    Rate of stent fractures at 12 months post-index procedure

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

    Time frame: At 12 months post-index procedure

    Rate of stent fractures at 12 months post-index procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Kwame Ofori

CONTACT

[email protected]

832-407-3326

Rajesh Nathan

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Collaborators

  • Rede Optimus Hospitalar SA

Registry information

Official study 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)

Acronym: REAL-SMART

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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