Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Interventions: Device: Shockwave Lithoplasty® Peripheral Lithoplasty System
Drug: Medtronic IN.PACT (DCB)

Registration Number: NCT02923193

Lead Sponsor: Shockwave Medical, Inc.

Brief Summary: Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand.

In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.

The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study.

A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.

Results for the observational study will be reported in a separate record under NCT05881421.

Detailed Description: Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. The Shockwave Medical Peripheral Lithoplasty System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to 400 subjects at 60 sites in Europe, the United States and New Zealand.

Subjects will be followed through discharge, 30 days, and 6, 12 and 24 months. DUS assessments will be completed at 12 and 24 months. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.

Subjects who do not meet the randomized study inclusion and exclusion criteria, but meet the inclusion and exclusion criteria for the observational study may be enrolled in the observational study. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 22 months. Subjects in the observational study will be followed through hospital discharge. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria. Results for the observational study will be reported in a separate record under NCT05881421.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 306

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lithoplasty System followed by DCB	Medtronic IN.PACT (DCB)	Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty
Medtronic IN.PACT (DCB)	Medtronic IN.PACT (DCB)	Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.
Lithoplasty System followed by DCB	Shockwave Lithoplasty® Peripheral Lithoplasty System	Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty

Primary Outcome Measures

Name	Time	Method
Number of Participants With Procedural Success	Peri-Procedural, approximately 2 hours	Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.

Secondary Outcome Measures

Name	Time	Method
Clinical Success Quality of Life	24 months	Defined by Quality of Life assessed by EQ5D questionnaire reported at 24 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status.
Clinical Success Rutherford Category	24 months	Defined as Rutherford Category reported at 24 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
Number of Participants With Primary Patency	24 months	Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis.
Number of Participants With Major Adverse Events (MAEs)	24 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
Clinical Success ABI	24 months	Defined as ankle-brachial index ABI reported at 24 months 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)	24 months	Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI \>20% or \>0.15 when compared to the 30-day ABI and associated with an angiographic lesion \>50% at the target lesion site

Trial Locations

Locations (54): Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Stanford Hospital
🇺🇸
Palo Alto, California, United States
Rocky Mountain Regional VA Medical Center
🇺🇸
Aurora, Colorado, United States
UCHealth Northern Colorado
🇺🇸
Loveland, Colorado, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Tallahassee Research Institute, Inc.
🇺🇸
Tallahassee, Florida, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Northeast Georgia Medical Center
🇺🇸
Gainesville, Georgia, United States
Alexian Brothers Medical Center
🇺🇸
Elk Grove Village, Illinois, United States
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Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States