Comparing lithotripsy and standard preparation for treating femoropopliteal artery disease
Performance of the Shockwave Medical Peripheral Lithotripsy System vs Standard Balloon Angioplasty for Lesion Preparation Prior to Supera Stent Implantation in the Treatment of Symptomatic Severely Calcified Femoropopliteal Lesions in PAD
This study is testing whether a new treatment called lithotripsy is safer and more effective than standard methods for helping people with femoropopliteal artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 1 site (Leipzig, Saxony) |
| Trial ID | NCT06112171 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the safety and efficacy of intravascular lithotripsy versus standard lesion preparation methods, such as balloon angioplasty, in patients suffering from femoropopliteal artery disease. Participants will be randomly assigned to receive either treatment, followed by the implantation of a Supera stent. The study will monitor patients for up to 60 months, assessing the incidence of restenosis at various follow-up intervals. The trial aims to provide insights into the effectiveness of lithotripsy in managing severe calcification in peripheral arterial disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant stenosis in their femoropopliteal arteries and severe calcification.
Not a fit: Patients with previous stenting in the target lesion or those with less severe arterial disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with severe calcification in their femoropopliteal arteries.
How similar studies have performed: While the approach of using lithotripsy is gaining interest, this specific comparison with standard preparation methods is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥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 Criteria: * 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
Where this trial is running
Leipzig, Saxony
- University Clinic Leipzig — Leipzig, Saxony, Germany (Recruiting)
Study contacts
- Principal investigator: Sabine Steiner, Prof. Dr. — University Leipzig
- Study coordinator: Sabine Steiner, Prof. Dr.
- Email: Sabine.Steiner@medizin.uni-leipzig.de
- Phone: +49-341-97
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.