Comparing lithotripsy and standard preparation for treating femoropopliteal artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.