Actively Recruiting
Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
Led by University of Leipzig · Updated on 2026-05-06
120
Participants Needed
1
Research Sites
463 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion. Patients will be stratified for total occlusions.
CONDITIONS
Official Title
Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent approved by Medical Ethics Committee
- Willingness to attend follow-up visits and complete required testing
- Rutherford Classification between 2 and 5
- Presence of a de novo or restenotic lesion in the superficial femoral artery and/or popliteal artery with 70% or greater stenosis
- No previous stent in the target lesion or previously stented vessel with stents at least 3 cm apart
- Target lesion length of at least 10 cm
- Severe calcification on fluoroscopy defined by PACSS Grade 4 with bilateral calcification extending 50 mm or more
- Multiple lesions with a maximum 3 cm healthy vessel segment in between may be treated as one lesion
- Reference vessel diameter between 4 mm and 6.5 mm
- At least one infrapopliteal artery with less than 50% diameter stenosis connected to the native femoropopliteal artery
- Successful guidewire crossing of the target treatment segment
You will not qualify if you...
- Failure to successfully cross the target lesion with a guidewire
- Presence of fresh thrombus in the lesion
- Presence of aneurysm in the target vessel(s)
- Presence of a stent in the target lesion less than 3 cm from any previous stent
- Prior vascular surgery on the target lesion
- Stroke or heart attack within 3 months prior to enrollment
- Participation in another investigational drug, device, or biologic study that has not reached its primary endpoint
- Life expectancy less than one year
- Known allergies or sensitivity to heparin, aspirin, other anticoagulants/antiplatelet therapies, or contrast media that cannot be treated beforehand
- Rutherford Classification of 0, 1, or 6
- Significant gastrointestinal bleeding or coagulopathy contraindicating antiplatelet therapy
- Receiving immunosuppressant therapy
- Pregnant or breastfeeding females
- History of major amputation above the ankle in the same limb as the target lesion
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Clinic Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
Research Team
S
Sabine Steiner, Prof. Dr.
CONTACT
J
Janine Brunotte
CONTACT
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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