NCT05831319

Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures

A Prospective, Multicenter, Observational Study Evaluating Standard of Care Practices, Procedural Outcomes, and In-hospital Complications of Endovascular Procedures for Treatment of Atherosclerotic Lesions in the Infrainguinal Arteries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 380 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.

Detailed description

The study will enroll consecutive eligible subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries. The purpose of this prospective, multicenter, observational European Study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.

Conditions

• Peripheral Arterial Disease

Timeline

• Start date: 2023-05-29
• Primary completion: 2024-06-01
• Completion: 2024-10-30
• First posted: 2023-04-26
• Last updated: 2024-11-01

Locations

17 sites across 8 countries: Austria, Belgium, France, Germany, Hungary, Italy, Spain, Switzerland