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Intravascular Lithotripsy

Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) for Peripheral Vascular Disease (Disrupt PAD+ Trial)

N/A
Waitlist Available
Research Sponsored by Shockwave Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
General Inclusion Criteria
Subject is able and willing to comply with all assessments in the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Disrupt PAD+ Trial Summary

This study is evaluating whether a new device may help treat calcified arteries.

Eligible Conditions
  • Peripheral Vascular Disease
  • Peripheral Arterial Disease

Disrupt PAD+ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Disrupt PAD+ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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 Lesions With Technical Success
Secondary outcome measures
Ankle-brachial Index (ABI) Reported as Change From Baseline
Number of Lesions With IVL Technical Success
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
+4 more

Disrupt PAD+ Trial Design

1Treatment groups
Experimental Treatment
Group I: Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)
2021
N/A
~40

Find a Location

Who is running the clinical trial?

Shockwave Medical, Inc.Lead Sponsor
27 Previous Clinical Trials
8,114 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~9 spots leftby Mar 2025