Clinical trial NCT05881421: DISRUPT PAD III Observational Study
Official title: Prospective Multi-Center, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: Intravascular Lithotripsy
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 1373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presenting to the study sites with known PAD requiring an interventional procedure were evaluated for eligibility and participation in the study. If a patient met the baseline pre-procedure screening of inclusion and none of the exclusion criteria for the protocol version current at time of screening, and was willing to participate in the study, written consent was obtained. No study-specific requirements were performed prior to obtaining informed consent.

Brief summary: The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions.

Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.


Eligibility criteria: Inclusion Criteria:

Subjects were required to meet ALL of the following inclusion criteria in order to be included in this clinical study:

1. Subjects intended to be treated with Shockwave Medical Lithoplasty for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
2. Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limb.
3. Age of subject is \> 18.
4. Subject of subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
5. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \<50mm in length.

Exclusion Criteria:

Subjects that met ANY of the following exclusion criteria were not included in this clinical study:

1. Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Lithoplasty as per Instructions for Use (IFU) or investigator's opinion.
2. Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Primary outcomes:
measure: Procedural Success - Primary Effectiveness Endpoint
timeFrame: Peri-procedural, approximately 2 hours
Secondary outcomes:
measure: Procedural Success - Secondary Effectiveness Endpoint
timeFrame: Peri-procedural, approximately 2 hours
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
city: Loveland
country: United States
facility: UCHealth Northern Colorado
state: Colorado
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Tallahassee
country: United States
facility: Tallahassee Research Institute Inc.
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Brighton
country: United States
facility: Steward St. Elizabeth's Medical Center
state: Massachusetts
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Cardiovascular Consultants
state: Missouri
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Raleigh
country: United States
facility: NC Heart & Vascular Research, LLC
state: North Carolina
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Bartlesville
country: United States
facility: St. John Clinic
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Memphis
country: United States
facility: Baptist Medical Center
state: Tennessee
city: Austin
country: United States
facility: St. David's Heart and Vascular (Austin Heart)
state: Texas
city: Houston
country: United States
facility: Baylor Clinic McNair Campus
state: Texas
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Mülheim
country: Germany
facility: Evangelisches Krankenhaus Mulheim an der Ruhr
city: Münster
country: Germany
facility: St. Franziskus Hospital
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
References: