Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

NCT ID: NCT06112171

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-13
• Study Completion Date: 2030-12-31

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 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.

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravascular lithotripsy arm

Treatment with Lithotripsy system followed by Supera stent implantation in lesion segments with severe calcification.

Group Type: OTHER

Intravascular lithotripsy

Intervention Type: PROCEDURE

Lesion preparation with Shockwave Medical Peripheral Lithotripsy System

Standard lesion preparation arm

Treatment with Balloon angioplasty with a conventional and/or high-pressure balloon angioplasty followed by Supera stent implantation in lesion segments with severe calcification.

Group Type: OTHER

Standard lesion preparation

Intervention Type: PROCEDURE

Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty

Interventions

Intravascular lithotripsy

Lesion preparation with Shockwave Medical Peripheral Lithotripsy System

Intervention Type: PROCEDURE

Standard lesion preparation

Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Steiner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Leipzig

Locations

University Clinic Leipzig

Leipzig, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sabine Steiner, Prof. Dr.

Role: CONTACT

Sabine.Steiner@medizin.uni-leipzig.de

+49-341-97 ext. 18770

Janine Brunotte

Role: CONTACT

janine.brunotte@medizin.uni-leipzig.de

+49-341-97 ext. 18770

Facility Contacts

Janin Lenzer

Role: primary

janin.lenzer@medizin.uni-leipzig.de

+49-341-97 ext. 18774

Other Identifiers

CIP_23/001

Identifier Type: -

Identifier Source: org_study_id