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

Official title

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

Overview

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.

Interventions

• Procedure Intravascular lithotripsy
  Lesion preparation with Shockwave Medical Peripheral Lithotripsy System
• Procedure Standard lesion preparation
  Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty

Primary outcome measures

• Primary efficacy [Time frame: During the Procedure]
• Rate of primary outcome events [Time frame: 12 month]

Secondary outcome measures (12)

• Rate of vessel rupture [Time frame: During the Procedure]
• Need of additional stent implantation [Time frame: During the Procedure]
• Procedure Time (min) [Time frame: During the Procedure]
• Fluoroscopy Duration (min) [Time frame: During the Procedure]
• Radiation dose area product [Time frame: During the Procedure]
• Additional need of intra-procedural pain medication [Time frame: During the Procedure]
• Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain) [Time frame: During the Procedure]
• Rate of any dissections after lesion preparation and in the final angiogram [Time frame: During the Procedure]
• Rate of primary patency [Time frame: 6, 12, 24 and 36 months]
• Rate of Duplex-defined binary restenosis (PVR >2.4) of the target lesion [Time frame: post-procedure until discharge from hospital (up to 48 hours) and at 6, 12, 24 and 36 months or at any time of re-intervention]
• Rate of Clinically-driven Target lesion revascularization [Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months]
• Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation) [Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 1 center

• University Clinic Leipzig — Leipzig

Identifiers

NCT: NCT06112171 · CIP_23/001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗