Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System

Not Applicable

Completed

Conditions: Peripheral Arterial Disease
Vascular Disease, Peripheral

Interventions: Device: Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)

Registration Number: NCT04585763

Lead Sponsor: Shockwave Medical, Inc.

Brief Summary: Prospective, multi-center, single-arm study of the M5+ Peripheral IVL system to treat calcified peripheral arteries.

Detailed Description: The objective of this study is to assess the safety and performance of the Shockwave M5+ Peripheral IVL System to treat calcified peripheral arteries in pre-market countries, and to assess continued safety and effectiveness in the US. A minimum of 40 lesions in up to 40 subjects at up to 10 sites in Australia, New Zealand and the US will be enrolled with the aim of treating at least 20 target lesions with the 8.0 mm IVL catheter. A maximum of three target lesions may be treated per subject. Subjects with moderate and severely calcified iliac and femoropopliteal artery disease presenting with Rutherford Category 2 to 5. Approximately 6 months of enrollment at up to 10 sites in Australia, New Zealand and the US. Study subjects will be followed through discharge, 30 days, 6 and 12 months. Duplex Ultrasound (DUS) assessments will be completed at 12 months. Total anticipated study duration is 18 months. The primary safety endpoint is Major Adverse Events (MAE) at 30 days defined as: need for emergency surgical revascularization of target limb; unplanned target limb major amputation (above the ankle); symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization ; or perforations that require an intervention, including bail-out stenting. The primary performance endpoint is technical success defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion by angiographic core lab.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)	-

Primary Outcome Measures

Name	Time	Method
Number of Lesions With Technical Success	Peri-procedural, approximately 2 hours	Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion by angiographic core lab.
Number of Participants With Major Adverse Events (MAE)	30 days	Defined as: Need for emergency surgical revascularization of target limb * Unplanned target limb major amputation (above the ankle) * Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization * Perforations that require an intervention, including bail-out stenting

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Procedural Success	Peri-procedural, approximately 2 hours	Defined as final residual stenosis ≤30% without any flow-limiting dissection (≥ Grade D) in all target lesions by angiographic core lab
Rutherford Category Reported as Change From Baseline	12 months	Number of Participants with Improvement in Rutherford Score from as reported at 12 Months post-procedure.
Ankle-brachial Index (ABI) Reported as Change From Baseline	12 months	ABI at 12 months reported as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)	12 months	A target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed. Clinically driven target lesion revascularization occurs in the absence of protocol directed surveillance ultrasound or angiography.
Number of Participants With Major Adverse Events (MAE)	12 months	* Need for emergency surgical revascularization of target limb * Unplanned target limb major amputation (above the ankle) * Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization * Perforations that require an intervention, including bail-out stenting
Number of Participants With Primary Patency	12 months	Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram ≥50% stenosis
Number of Lesions With IVL Technical Success	Peri-procedural, approximately 2 hours	Defined as residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion post-IVL by angiographic core lab

Trial Locations

Locations (8): Auckland City Hospital
🇳🇿
Auckland, New Zealand
Midwest Cardiovascular Research Foundation
🇺🇸
Davenport, Iowa, United States
St. John Clinic
🇺🇸
Bartlesville, Oklahoma, United States
Prince of Wales Hospital
🇦🇺
Randwick, New South Wales, Australia
Perth Institute of Vascular Research
🇦🇺
Nedlands, Western Australia, Australia
NC Heart and Vascular Research
🇺🇸
Raleigh, North Carolina, United States
Christchurch Hospital
🇳🇿
Christchurch, New Zealand
Waikato District Hospital
🇳🇿
Hamilton, New Zealand