DISRUPT PAD III Observational Study

Peripheral Arterial Disease Clinical Trial

— PAD III OS  

Official title:

Prospective Multi-Center, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881421
• Other study ID #: CP 60892 OS
• Status: Completed
• Start date: November 16, 2017
• Est. completion date: June 10, 2021

Study information

• Verified date: May 2023
• Source: Shockwave Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1373
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shockwave Medical, Inc.

Countries where clinical trial is conducted

United States,  Germany,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Success - Primary Effectiveness Endpoint	Defined as final residual stenosis =30% without flow-limiting dissection (= grade D) by angiographic core lab. In the primary analysis, Procedural Success was assessed on a per-subject basis; for subjects with multiple IVL-treated lesions, Procedural Success was achieved if all lesions met criteria.	Peri-procedural, approximately 2 hours
Secondary	Procedural Success - Secondary Effectiveness Endpoint	As secondary analyses, Procedural Success was also assessed on a per-lesion basis, as well as using a <50% residual stenosis threshold.	Peri-procedural, approximately 2 hours