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

NCT06112171 | Recruiting

• 1 other identifier: CIP_23/001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Calcification; Lithotripsy

Outcome Measures

Primary Outcomes (2)

• Primary efficacy

  Procedural success defined as residual stenosis ≤ 30% without flow-limiting dissection (≥Grade D) in the final angiogram and without the need of additional stent implantation.

  During the Procedure

• Rate of primary outcome events

  Composite endpoint defined as freedom from device and procedure-related death, freedom from both target limb major amputation and clinically-driven target lesion revascularization

  12 month

Secondary Outcomes (18)

• Rate of vessel rupture

  During the Procedure

• Need of additional stent implantation

  During the Procedure

• Procedure Time (min)

  During the Procedure

• Fluoroscopy Duration (min)

  During the Procedure

• Radiation dose area product

  During the Procedure

Study Arms (2)

Intravascular lithotripsy arm

OTHER

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

Procedure: Intravascular lithotripsy

Standard lesion preparation arm

OTHER

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

Procedure: Standard lesion preparation

Interventions

Intravascular lithotripsy PROCEDURE

Lesion preparation with Shockwave Medical Peripheral Lithotripsy System

Intravascular lithotripsy arm

Standard lesion preparation PROCEDURE

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

Standard lesion preparation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Clinic Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Calcinosis

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sabine Steiner, Prof. Dr.

  University Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Steiner, Prof. Dr.

CONTACT

+49-341-97; Sabine.Steiner@medizin.uni-leipzig.de

Janine Brunotte

CONTACT

+49-341-97; janine.brunotte@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 1, 2023
• Study Start: February 13, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)