Breaking up arterial calcification with intravascular lithotripsy to improve blood flow in people with PAD
Official title: Trial to Investigate the Shockwave Intravascular Lithotripsy (IVL) on Vascular Compliance in Heavily Calcified Femoropopliteal Disease (PACSS 2-4)
Run by University Hospital, Essen · NCT07130526 · Data updated 2026-11-12
This trial tests whether intravascular lithotripsy plus a drug-coated balloon works better than standard balloon angioplasty plus a drug-coated balloon for people with PAD and heavy artery calcification.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospital, Essen Academic / other |
| Locations | 2 sites (Essen, North Rhine-Westphalia and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | April 20, 2026 |
| Study ends | June 20, 2026 |
| Registry record updated | August 19, 2025 |
| Trial ID | NCT07130526 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–85 years with symptomatic lower-limb ischemia (Rutherford 2–5) and severe target-vessel calcification (PACCS 2–4) in the distal EIA, CFA, proximal SFA, or popliteal artery who are planned for an endovascular procedure.
✕Probably not a fit
Patients without severe calcification, with instent restenosis, aneurysms at the target site, recent MI or stroke within 30 days, life expectancy under 12 months, or other listed exclusions are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with symptomatic peripheral arterial disease and severe calcification in iliac, femoral or popliteal target lesions will receive either intravascular lithotripsy (IVL) plus a drug-coated balloon (DCB) or plain old balloon angioplasty (POBA) plus DCB. Vascular function, vessel compliance, and vasomotion will be measured with ultrasound alongside procedural endpoints such as dissections, need for bail-out stenting, and short-term patency. Participants will be followed at specified intervals after the index procedure to record clinical outcomes and wound healing. The trial aims to determine whether IVL-mediated calcium fracture improves procedural success and hemodynamic performance compared with standard balloon techniques.
Why it matters
Potential benefit: If successful, the approach could increase vessel flexibility, lower complication rates like major dissections and stent need, and improve leg blood flow and wound healing.
How similar studies have gone: Prior IVL experience in heavily calcified coronary and peripheral lesions has shown good procedural success with fewer major dissections and reduced need for bail-out stenting, though effects on long-term vascular compliance are less well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Peripheral artery disease * Severe Calcification PACCS 2,3 and 4 * Target lesions in distal EIA, CFA, prox. SFA or PA * Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5 * Planed peripheral intervention TASC A-D * Subject must be between 18 and 85 years old * Willing to comply with the specified follow-up evaluation * Written informed consent prior to any study procedures Exclusion Criteria: * Target lesions with no optimal visualization in ultrasound * Instent-Restenosis * Thrombolysis within 72 hours prior to the index procedure * Aneurysm formations in the femoral artery or popliteal artery * Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy * Unstable angina pectoris at the time of the enrolment * Recent myocardial infarction or stroke \< 30 days prior to the index procedure * Life expectancy less than 12 months * Septicemia at the time of enrolment * Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb * Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin
Where it's running
-
University of Duisburg-Essen
Essen, Germany Recruiting -
West German Heart and Vascular Center, Clinic for Cardiology and Vascular Medicine, Universtiy Hospital Essen
Essen, North Rhine-Westphalia, Germany Not yet recruiting
Study contacts
- Study coordinator: Christos Rammos, Prof. Dr. med.
- Email: christos.rammos@uk-essen.de
- Phone: 0201-723-4801
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.