CompletedNot Applicable

Shockwave IVL + DES

Germany50 participantsStarted 2022-07-22

Plain-language 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.

Who can participate

Age range21 Years – 85 Years

SexALL

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Inclusion criteria

✓. Degree of stenosis ≥ 70% by visual agiographic assessment
✓. Vessel diameter ≥ 4 and ≥ 6 mm
✓. Total lesion length (or series of lesions) ≥ 30 mm and 210 mm (Note: Lesion segment(s) must be filly covered with one or two overlapping DES stent (s) be fully covered with one or two overlapping DES stent(s)
✓. Target lesion located at least three centimeters above the inferior edge of the femur

What they're measuring

Primary Patency

Timeframe: 12 months

Procedural success:

Timeframe: 30 days post procedure

Trial details

NCT IDNCT05291247

SponsorMarc Bosiers, MD

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-23

View on ClinicalTrials.gov More Peripheral Arterial Disease trials