NCT05312580

PMCF Study for Peripheral Arteries Above the Knee (ATK)

A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter for the Endovascular Interventions in the Ilio-femoropopliteal Vessels

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 387 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.

Conditions

• Peripheral Arterial Disease
• Femoropopliteal Stenosis
• Angiopathy, Peripheral

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-10-07
• Completion: 2022-11-07
• First posted: 2022-04-05
• Last updated: 2023-07-27

Locations

9 sites across 3 countries: Austria, France, Netherlands