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

NCT02923193 | Completed Results DMC FDA Device

• 1 other identifier: CP 60892
• Study Type: interventional
• Target: 306
• Locations: 4 countries
• Sites: 54

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Procedural Success

  Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.

  Peri-Procedural, approximately 2 hours

Secondary Outcomes (22)

• Number of Participants With Major Adverse Events (MAEs)

  30 days

• Clinical Success ABI

  30 days

• Clinical Success Quality of Life

  30 days

• Clinical Success Rutherford Category

  30 days

• Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)

  30 days

Study Arms (2)

Lithoplasty System followed by DCB

EXPERIMENTAL

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

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

Medtronic IN.PACT (DCB)

ACTIVE COMPARATOR

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.

Drug: Medtronic IN.PACT (DCB)

Interventions

Shockwave Lithoplasty® Peripheral Lithoplasty System DEVICE

The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.

Lithoplasty System followed by DCB

Medtronic IN.PACT (DCB) DRUG

The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis.

Also known as: drug coated balloon

Lithoplasty System followed by DCB; Medtronic IN.PACT (DCB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able and willing to comply with all assessments in the study.
• Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
• Age of subject is greater than or equal to 18.
• Rutherford Clinical Category 2, 3, or 4 of the target limb.
• Estimated life expectancy \>1 year.
• Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
• Subject is intended to undergo treatment with Lithoplasty followed by DCB, or DCB with standard balloon pre-dilatation.
• Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).
• Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
• Target lesion is ≥70% stenosis by investigator via visual estimate.
• Target lesion length is ≤180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.
• Chronic total occlusion, lesion length is ≤100mm of the total ≤180 mm target lesion.
• Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis \>50%.
• 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.

You may not qualify if:

• Rutherford Clinical Category 0, 1, 5 and 6.
• Subject has active infection requiring antibiotic therapy.
• Planned target limb major amputation (above the ankle).
• History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
• Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter.
• Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
• Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Subject has known allergy to urethane, nylon, or silicone.
• Myocardial infarction within 60 days prior to enrollment.
• History of stroke within 60 days prior to enrollment.
• History of thrombolytic therapy within two weeks of enrollment.
• Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 umol/L, or on dialysis.
• Subject is pregnant or nursing.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (54)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Stanford Hospital

Palo Alto, California, 94304, United States

Location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

UCHealth Northern Colorado

Loveland, Colorado, 80538, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tallahassee Research Institute, Inc.

Tallahassee, Florida, 32308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Advocate Health and Hospitals Corporation

Naperville, Illinois, 60540, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62769, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Steward St. Elizabeth's Medical Center

Brighton, Maine, 02135, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48431, United States

Location

Ascension / St. John Providence

Southfield, Michigan, 48075, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Saint Luke's Cardiovascular Consultants

Kansas City, Missouri, 64111, United States

Location

St. Luke's East Hospital

Lee's Summit, Missouri, 64086, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

St. John Clinic

Bartlesville, Oklahoma, 74006, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

PinnacleHealth Harrisburg Hospital

Harrisburg, Pennsylvania, 17101, United States

Location

Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, 19141, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Baptist Medical Center

Memphis, Tennessee, 38120, United States

Location

St. David's Heart and Vascular dba Austin Heart

Austin, Texas, 78756, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Medizinische Universitaet Graz

Graz, 8036, Austria

Location

Gefäßsambulanz

Vienna, 1140, Austria

Location

Karolinen-Hospital

Arnsberg, 59759, Germany

Location

Universitäts-Herzzentrum Freiburg & Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Sankt Gertrauden-Krankenhaus

Berlin, 10713, Germany

Location

Leiter Sektion Angiologie

Bonn, 53127, Germany

Location

Medizinische Klinik II

Bruchsal, 76646, Germany

Location

Klinik für Gefäßmedizin

Hamburg, 21075, Germany

Location

Universitätsklinikum Leipzig AoR Leipzig

Leipzig, 04103, Germany

Location

Katholisches Klinikum Mainz

Mainz, 55131, Germany

Location

Evangelisches Krankenhaus Mühlheim an der Ruhr

Mülheim, 45468, Germany

Location

St. Franziskus Hospital

Münster, 48145, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Related Publications (3)

• Nagpal S, Altin SE, McGinigle K, Mangalmurti SS, Adams G, Shammas NW, Mehrle A, Soukas P, Bertolet B, Lansky AJ. Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study. J Vasc Surg. 2024 Feb;79(2):358-365. doi: 10.1016/j.jvs.2023.10.058. Epub 2023 Nov 2.

  PMID: 37925039 DERIVED

• Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.

  PMID: 34167675 DERIVED

• Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020 Jun;27(3):473-480. doi: 10.1177/1526602820914598. Epub 2020 Apr 3.

  PMID: 32242768 DERIVED

Related Links

• Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: A cohort analysis from the Disrupt PAD III Study

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Birgit Greschner
• Organization: Shockwave Medical

bgreschner@shockwavemedical.com

650-575-6199

Study Officials

• Gunnar Tepe, MD

  RoMed Klinikum Rosenheim

  PRINCIPAL INVESTIGATOR

• William A Gray, MD

  Main Line Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 4, 2016
• Study Start: February 22, 2017
• Primary Completion: May 12, 2020
• Study Completion: June 2, 2022
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); AU (2); DE (11); US (40)