Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent
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.
| Condition(s) | Peripheral Arterial Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 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. |
| Who can participate | Inclusion Criteria: * 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 ≥5 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Leipzig |
| Locations | Leipzig, Saxony, Germany |
| Start date | 2024-02-13 |
| NCT ID | NCT06112171 |
| Official listing | https://clinicaltrials.gov/study/NCT06112171 |