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

NCT04585763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-01-03

Study results available
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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

Interventions

DEVICE

Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)

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.

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2021-08-25
Completion
2022-11-21
FDA Device
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585763 on ClinicalTrials.gov