Post-Market Clinical Follow-Up Study of the S.M.A.R.T. TM Nitinol Stent System, S.M.A.R.T. TM CONTROL TM Nitinol Stent System and S.M.A.R.T. TM Flex Vascular Stent System in the Treatment of Iliac and Femoropopliteal Artery Disease (REAL-SMART)

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

Public Health Interest of the Project: Peripheral arterial disease (PAD) involving the iliac and femoropopliteal arteries is a major cause of lower limb ischemia, pain, and disability, and is associated with a high risk of cardiovascular morbidity and mortality. This Post-Market Clinical Follow-Up (PMCF) study will generate five-year, real-world evidence on the safety and performance of the S.M.A.R.T.™, S.M.A.R.T.™ CONTROL™, and S.M.A.R.T.™ FLEX Nitinol Stent Systems in patients with atherosclerotic lesions of the iliac, superficial femoral, and proximal popliteal arteries. By characterizing long-term outcomes — such as vessel patency, restenosis and reintervention rates, limb amputation, and serious device- or procedure-related adverse events — the study will support the continued safe and effective use of these stent systems in clinical practice. The resulting evidence serves the public interest by safeguarding patients, enhancing regulatory oversight and post-market vigilance, informing clinical decision making, and supporting quality improvement in the endovascular management of peripheral arterial disease. Study Objectives: To evaluate the long-term (5-year) safety and performance of the S.M.A.R.T.™, S.M.A.R.T.™ CONTROL™, and S.M.A.R.T.™ FLEX Nitinol Stent Systems in subjects with stenotic or occlusive lesions of the iliac, superficial femoral, or proximal popliteal arteries. Study Design: This is a multi-center, non-randomized, observational analysis of retrospective data collected on subjects treated with the S.M.A.R.T.™, S.M.A.R.T.™ CONTROL™, or S.M.A.R.T.™ FLEX Nitinol Stent Systems. Each device constitutes a separate study arm, enabling independent evaluation of safety and performance per vascular territory and device type. Subject Selection for Data Mining: For data mining purposes, the following criteria will apply in determining which subjects to include in the study: 1. Subjects treated with a S.M.A.R.T.™, S.M.A.R.T.™ CONTROL™, or S.M.A.R.T.™ FLEX Nitinol Stent System according to the respective Instructions for Use for the treatment of iliac, superficial femoral, and/or proximal popliteal artery disease. 2. If an Ethics Committee (EC)-approved informed consent waiver is not obtained, documented informed consent from the subject or their legal representative granting permission to share clinical data will be required. 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 occurs 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 comparable to subjects with follow-up data who are included in the study. Exclusion Criteria: 1. Women who were pregnant or lactating at the time of the procedure. 2. Pediatric subjects (<18 years of age) at the time of the procedure.