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

NACompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

February 16, 2021

Primary Completion Date

August 25, 2021

Study Completion Date

November 21, 2022

Conditions
Peripheral Arterial DiseaseVascular 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.

Trial Locations (8)

1023

Auckland City Hospital, Auckland

2031

Prince of Wales Hospital, Randwick

3204

Waikato District Hospital, Hamilton

6009

Perth Institute of Vascular Research, Nedlands

8011

Christchurch Hospital, Christchurch

27607

NC Heart and Vascular Research, Raleigh

52803

Midwest Cardiovascular Research Foundation, Davenport

74006

St. John Clinic, Bartlesville

All Listed Sponsors
lead

Shockwave Medical, Inc.

INDUSTRY

NCT04585763 - Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System | Biotech Hunter | Biotech Hunter