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Angioplasty Device

Shockwave for Vascular Disease

N/A
Waitlist Available
Led By Mathew Wooster, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failure of device to track with external pressure applied to abdomen
Patient intolerance of advancement (pain response) in awake patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights

Study Summary

This trial is testing a new way to do a common medical procedure that has a risk of complications. The new method being tested is hoped to reduce the risk of complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The device used to track something on the abdomen doesn't work properly when pressure is applied to it from the outside.
Select...
You are unable to tolerate the discomfort or pain experienced during the procedure while being awake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful advancement of planned large bore access device

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ShockwaveExperimental Treatment1 Intervention
The second 50 patients will be treated primarily with Shockwave
Group II: Standard POBA (plain old balloon angioplasty)Active Control1 Intervention
The first 50 patients will be pre-treated with standard POBA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shockwave
2023
N/A
~30

Find a Location

Who is running the clinical trial?

Shockwave Medical, Inc.Industry Sponsor
27 Previous Clinical Trials
8,144 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
929 Previous Clinical Trials
7,393,810 Total Patients Enrolled
Mathew Wooster, MD3.02 ReviewsPrincipal Investigator - Medical University of South Carolina
Medical University of South Carolina
1Patient Review
Unacceptable

Media Library

Shockwave Medical, Inc. Peripheral Lithoplasty® System (Angioplasty Device) Clinical Trial Eligibility Overview. Trial Name: NCT04600934 — N/A
Vascular Disease Research Study Groups: Standard POBA (plain old balloon angioplasty), Shockwave
Vascular Disease Clinical Trial 2023: Shockwave Medical, Inc. Peripheral Lithoplasty® System Highlights & Side Effects. Trial Name: NCT04600934 — N/A
Shockwave Medical, Inc. Peripheral Lithoplasty® System (Angioplasty Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04600934 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you still accept volunteers for this clinical trial?

"Affirmative. According to the data available on clinicaltrials.gov, this clinical trial is actively recruiting and was first listed on October 3rd 2022. The study requires 100 participants at one medical centre for completion."

Answered by AI

How many participants is this clinical trial enrolling?

"Affirmative. According to clinicaltrials.gov, this trial is on the lookout for participants who meet its criteria; it was first posted in October 3rd 2022 and has since had updates made to it. 100 people are sought from a single site for inclusion in the study."

Answered by AI
~3 spots leftby Mar 2025