Status:
RECRUITING
Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
Lead Sponsor:
University of Leipzig
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 les...
Detailed Description
All enrolled subjects will be followed up through 60 months. At 6, 12, 24, 36 MFU after index procedure the incidence of restenosis will be assessed by DUS.
Eligibility Criteria
Inclusion
- Subject age ≥ 18
- Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form
- Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing
- Rutherford Classification 2-5
- Subject has a de novo or restenotic lesion in SFA and/or PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented angiographically
- No previous stent in the target lesion, if target vessel was previously stented the stent should be at least 3cm apart
- Target lesion length is ≥ 10cm, no maximum lesion length limit
- Severe calcification on fluoroscopy defined by PACSS Grade 4: 1) bilateral calcification and 2) extending ≥50mm in length
- Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion
- Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
- Patency of at least one infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery
- A guidewire has successfully traversed the target treatment segment (both intraluminal and subintimal crossing allowed)
Exclusion
- Failure to successfully cross the target lesion
- Presence of fresh thrombus in the lesion
- Presence of aneurysm in the target vessel/s
- Presence of a stent in the target lesion, at least 3cm from any previously stent in target vessel
- Prior vascular surgery of the target lesion
- Stroke or heart attack within 3 months prior to enrollment
- Enrolled in another investigational drug, device or biologic study that has not reached the primary endpoint
- Life expectancy of less than one year
- Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies or contrast media that cannot be adequately pre-treated prior to index procedure
- Rutherford Classification of 0, 1, or 6
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- Receiving immunosuppressant therapy
- Pregnant or breast-feeding females
- History of major amputation (defined as amputation above ankle joint) in the same limb as the target lesion
Key Trial Info
Start Date :
February 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06112171
Start Date
February 13 2024
End Date
December 31 2030
Last Update
January 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Clinic Leipzig
Leipzig, Saxony, Germany, 04103