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

NCT04585763 | Completed Results DMC FDA Device

• 1 other identifier: CP 64007
• Study Type: interventional
• Target: 37
• Locations: 3 countries
• Sites: 8

Brief Summary

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

Conditions

Peripheral Arterial Disease; Vascular Disease, Peripheral

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Major Adverse Events (MAE)

  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

  30 days

• Number of Lesions With Technical Success

  Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion by angiographic core lab.

  Peri-procedural, approximately 2 hours

Secondary Outcomes (12)

• Number of Lesions With IVL Technical Success

  Peri-procedural, approximately 2 hours

• Number of Participants With Procedural Success

  Peri-procedural, approximately 2 hours

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

  30 days

• Rutherford Category Reported as Change From Baseline

  30 days

• Number of Participants With Major Adverse Events (MAE)

  6 months

Study Arms (1)

Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)

EXPERIMENTAL

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

Interventions

Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) DEVICE

The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.

Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)

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 \> 18.
• Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).
• Estimated life expectancy \>1 year.
• Subject is intended to undergo treatment with Shockwave M5+ Peripheral IVL System for de novo lesions of the ilio-femoropopliteal arteries.
• Single or multiple de novo target lesion(s) located from the common iliac to the femoropopliteal artery, in one or both limbs.
• Target lesion reference vessel diameter is between 3.5mm and 8.0mm by visual estimate.
• Target lesion is ≥70% stenosis by investigator via visual estimate.
• Target lesion length is ≤200mm for lesions 70-99% stenosed. Target lesion can be all or part of the 200mm treated zone.
• Chronic total occlusion, lesion length is ≤100mm of the total ≤200 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, and 6.
• Subject has active infection requiring antibiotic therapy.
• History of endovascular or surgical procedure on the target limb within the last 30 days or planned within 30 days of the index procedure. Note: Concomitant IVL treatment to facilitate large bore access at the time of procedure is allowed.
• 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.
• Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 umol/L, unless 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.
• The planned use of specialty balloons, re-entry or atherectomy devices in the target lesion(s).
• In-stent restenosis within 10mm of the target zone.
• Target lesions distal to the popliteal artery.

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (8)

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

St. John Clinic

Bartlesville, Oklahoma, 74006, United States

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Perth Institute of Vascular Research

Nedlands, Western Australia, 6009, Australia

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Waikato District Hospital

Hamilton, 3204, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Birgit Greschner
• Organization: Shockwave Medical

bgreschner@shockwavemedical.com

650-575-6199

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: February 16, 2021
• Primary Completion: August 25, 2021
• Study Completion: November 21, 2022
• Last Updated: January 3, 2024
• Results First Posted: August 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (3); US (3); AU (2)