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Shockwave IVL + DES

NCT05291247 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-27

No results posted yet for this study

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

DEVICE

Peripheral lithotripsy system (Shockwave Medical)

The combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device for calcified femoropopliteal disease.

Sponsors & Collaborators

  • Marc Bosiers, MD

    lead OTHER

Principal Investigators

  • Konstantinos Stavroulakis, MD · Vascular Department, LMU Munich

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2025-09-23
Completion
2026-02-10

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291247 on ClinicalTrials.gov