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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Intravascular lithotripsy
* Procedure: Standard lesion preparation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intravascular lithotripsy arm<br>Treatment with Lithotripsy system followed by Supera stent implantation in lesion segments with severe calcification. | Procedure: Intravascular lithotripsy<br>* Lesion preparation with Shockwave Medical Peripheral Lithotripsy System<br>|
| Other: Standard lesion preparation arm<br>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<br>* Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Primary safety | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Additional need of intra-procedural pain medication |  | During the Procedure | 
| Perception of procedural pain evaluated using a numerical rating scale (0-10) |  | During the Procedure | 
| Patient satisfaction post procedure using a standardized questionnaire |  | During the Procedure | 
| Presence of any dissections after lesion preparation and in the final angiogram |  | During the Procedure | 
| Primary patency |  | 6, 12, 24 and 36 months | 
| Duplex-defined binary restenosis (PVR >2.4) of the target lesion |  | post-procedure and at 6, 12, 24 and 36 months or at any time of re-intervention | 
| Clinically-driven TLR |  | 30 days, 6, 12, 24, 36, 48 and 60 months | 
| Freedom from Major Adverse Event (defined as death, TLR, TVR and target limb major amputation) |  | 30 days, 6, 12, 24, 36, 48 and 60 months | 
| All-cause mortality |  | 30 days, 6, 12, 24, 36, 48 and 60 months | 
| Rutherford Classification |  | 6, 12, 24 and 36 months | 
| Ankle-brachial index (ABI) |  | 6, 12, 24 and 36 months | 
| EQ-5D-5L questionnaire |  | 6, 12, 24 and 36 months | 
| Walking Impairment Questionnaire (WIQ) |  | 6, 12, 24 and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcification, Lithotripsy