Shockwave IVL + DES (Shockwave DES)
Physician-Initiated PMCF Trial Investigating Shockwave Intravascular Lithotripsy and a Drug Eluting Vascular Stent System Deployment for Heavily Calcified Femoropopliteal Disease
Sponsor: Marc Bosiers, MD
This observational or N/A phase trial investigates Calcifications Vascular and Peripheral Arterial Disease and is currently completed. Marc Bosiers, MD leads this study, which shows 8 recorded versions since 2022 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
8 versions recorded-
Apr 28, 2026 — Present [daily]
Completed
-
Feb 2026 — Apr 2026 [monthly]
Completed
Status: Unknown → Completed
-
Aug 2025 — Feb 2026 [monthly]
Unknown
Status: Recruiting → Unknown
-
Sep 2024 — Aug 2025 [monthly]
Recruiting
-
Jul 2024 — Sep 2024 [monthly]
Recruiting
▶ Show 3 earlier versions
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Aug 2023 — Jul 2024 [monthly]
Recruiting
-
Dec 2022 — Aug 2023 [monthly]
Recruiting
Status: Not Yet Recruiting → Recruiting
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Apr 2022 — Dec 2022 [monthly]
Not Yet Recruiting
First recorded
Eligibility 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.
Contact Information
- Marc Bosiers, MD
For direct contact, visit the study record on ClinicalTrials.gov .