NCT05291247

Shockwave IVL + DES

Physician-Initiated PMCF Trial Investigating Shockwave Intravascular Lithotripsy and a Drug Eluting Vascular Stent System Deployment for Heavily Calcified Femoropopliteal Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Marc Bosiers, MD · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for PACSS 3 and PACSS 4 calcified femoropopliteal disease.

Conditions

• Peripheral Arterial Disease
• Superficial Femoral Artery Stenosis
• Calcifications Vascular

Interventions

Type	Name	Description
DEVICE	Peripheral lithotripsy system (Shockwave Medical)	The combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device for calcified femoropopliteal disease.

Timeline

• Start date: 2022-07-22
• Primary completion: 2025-09-23
• Completion: 2026-02-10
• First posted: 2022-03-22
• Last updated: 2026-02-27

Locations

6 sites across 1 country: Germany