Actively Recruiting
Trial to Investigate Shockwave Intravascular Lithotripsy (IVL) on Vascular Compliance in Severe Calcified Femoropopliteal Disease
Led by University Hospital, Essen · Updated on 2025-08-19
40
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Essen
Lead Sponsor
S
Shockwave Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Peripheral Arterial Disease (PAD) causes leg pain during exercise and can lead to chronic wounds due to poor blood supply. This condition is mainly caused by artery narrowing from build-up of fats and calcium, increasing risks especially in people with diabetes, high cholesterol, high blood pressure, obesity, or smoking. The trial investigates how a new treatment, intravascular lithotripsy (IVL), affects blood vessel stiffness and function compared to standard balloon angioplasty in patients with heavily calcified leg arteries. Participants will be randomly assigned to receive either IVL followed by a drug-coated balloon (DCB) or plain old balloon angioplasty (POBA) plus DCB. The IVL device uses sonic pressure waves to break calcium deposits inside the arteries, aiming to improve vessel flexibility and help widen the artery. Both treatments target leg arteries with severe calcification and are delivered via catheters during minimally invasive procedures. During the study, researchers will measure vessel stiffness and function using ultrasound and other imaging techniques before treatment, then again at 1 day and 30 days after the procedure. They will monitor blood flow, artery diameter changes, procedural success, complications, and need for additional treatments. Participants will have follow-up visits to assess healing and vessel performance over time, helping to understand the benefits and effects of IVL on vascular health.
CONDITIONS
Brief Title
Distrupt Stiffness Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have peripheral artery disease
- Have severe calcification classified as PACSS 2, 3, or 4
- Target lesions located in distal external iliac artery, common femoral artery, proximal superficial femoral artery, or popliteal artery
- Clinical diagnosis of chronic, symptomatic lower limb ischemia classified as Rutherford stages 2 to 5
- Planned peripheral intervention classified as TASC A to D
- Aged between 18 and 85 years
- Willing to comply with follow-up evaluations
- Provide written informed consent before any study procedures
You will not qualify if you...
- Target lesions not clearly visible by ultrasound
- Presence of in-stent restenosis
- Had thrombolysis within 72 hours before the procedure
- Presence of aneurysm in femoral or popliteal artery
- Have liver failure, deep vein thrombosis, blood clotting disorder, or receiving immunosuppressant therapy
- Unstable angina at enrollment
- Recent heart attack or stroke within 30 days before the procedure
- Life expectancy less than 12 months
- Septicemia at enrollment
- Active infection at the procedure time excluding an infected lower limb wound
- Known or suspected allergies to aspirin, clopidogrel, or heparin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive either intravascular lithotripsy plus drug-coated balloon or plain old balloon angioplasty plus drug-coated balloon to treat severely calcified peripheral arterial lesions.
1 treatment visit (in-person)
Duration - 30 days
Participants are monitored to assess vascular compliance and function, procedural complications, and vessel patency after treatment.
1 follow-up visit (in-person) approximately 30 days after treatment
Trial Site Locations
Total: 2 locations
1
West German Heart and Vascular Center, Clinic for Cardiology and Vascular Medicine, Universtiy Hospital Essen
Essen, North Rhine-Westphalia, Germany, 45147
Not Yet Recruiting
2
University of Duisburg-Essen
Essen, Germany, 45147
Actively Recruiting
Research Team
C
Christos Rammos, Prof. Dr. med.
D
Daniel Messiha, Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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