Breaking up arterial calcification with intravascular lithotripsy to improve blood flow in people with PAD
Trial to Investigate the Shockwave Intravascular Lithotripsy (IVL) on Vascular Compliance in Heavily Calcified Femoropopliteal Disease (PACSS 2-4)
NA · University Hospital, Essen · NCT07130526
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Essen (other) |
| Locations | 2 sites (Essen, North Rhine-Westphalia and 1 other locations) |
| Trial ID | NCT07130526 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Essen, North Rhine-Westphalia and 1 other locations
- West German Heart and Vascular Center, Clinic for Cardiology and Vascular Medicine, Universtiy Hospital Essen — Essen, North Rhine-Westphalia, Germany (NOT_YET_RECRUITING)
- University of Duisburg-Essen — Essen, Germany (RECRUITING)
Study contacts
- Study coordinator: Christos Rammos, Prof. Dr. med.
- Email: christos.rammos@uk-essen.de
- Phone: 0201-723-4801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PAD - Peripheral Arterial Disease, PAD, pad, peripheral artery disease, intravascular lithotripsy