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Device

Shockwave Lithoplasty® Peripheral Lithoplasty System for Peripheral Arterial Disease

N/A
Waitlist Available
Led By Gunnar Tepe, MD
Research Sponsored by Shockwave Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This study is evaluating whether a treatment for calcified arteries can be used in the real world.

Eligible Conditions
  • Peripheral Arterial Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Procedural Success
Secondary outcome measures
Clinical Success ABI
Clinical Success Quality of Life
Clinical Success Rutherford Category
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lithoplasty System followed by DCBExperimental Treatment2 Interventions
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
Group II: Medtronic IN.PACT (DCB)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shockwave Lithoplasty® Peripheral Lithoplasty System
2017
N/A
~310
Medtronic IN.PACT (DCB)
2017
N/A
~310

Find a Location

Who is running the clinical trial?

Shockwave Medical, Inc.Lead Sponsor
28 Previous Clinical Trials
7,860 Total Patients Enrolled
10 Trials studying Peripheral Arterial Disease
1,985 Patients Enrolled for Peripheral Arterial Disease
Gunnar Tepe, MDPrincipal InvestigatorRoMed Klinikum Rosenheim
11 Previous Clinical Trials
3,709 Total Patients Enrolled
6 Trials studying Peripheral Arterial Disease
3,050 Patients Enrolled for Peripheral Arterial Disease
William A Gray, MDPrincipal InvestigatorMain Line Health
5 Previous Clinical Trials
800 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
2017. "Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02923193.
~37 spots leftby May 2025
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