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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot take medications like aspirin or Plavix that prevent blood from clotting.You have previously had a stent placed in your common or external iliac artery.The device used to track something on the abdomen doesn't work properly when pressure is applied to it from the outside.You are unable to tolerate the discomfort or pain experienced during the procedure while being awake.You are unable to safely guide a wire through the iliac segment of your body.
Research Study Groups:
This trial has the following groups:- Group 1: Standard POBA (plain old balloon angioplasty)
- Group 2: Shockwave
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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