Your session is about to expire
← Back to Search
Other
Therapeutic Device for Peripheral Arterial Disease (Concerto Trial)
N/A
Recruiting
Research Sponsored by Vibrato Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of infrapopliteal PAD
Age ≥22
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Concerto Trial Summary
This trial will test a new device to improve circulation in people with blocked arteries.
Who is the study for?
This trial is for adults over 22 with severe peripheral artery disease (PAD) in the legs, specifically those classified as Rutherford class 4 or 5. Participants must have a Toe Brachial Index of 0.6 or less, or toe blood pressure below 50 mmHg. It's not for those who've had recent leg stents, re-vascularization procedures within the last month, skin issues on their calf, severe vein problems in their legs, recent acute limb ischemia, untreated deep vein thrombosis below the knee in the affected leg, uncontrolled diabetes with HbA1c over 10%, ongoing oxygen treatment under pressure or if they're part of another study.Check my eligibility
What is being tested?
The trial is testing a device called Vibrato Sleeve TUS to see if it's safe and effective for improving blood flow in people with PAD. The goal is to find out whether this therapeutic device can help patients by changing how much blood gets through their arteries.See study design
What are the potential side effects?
Since this trial involves a therapeutic device rather than medication, side effects may include local reactions at the site where the device is used such as discomfort or skin irritation.
Concerto Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a blockage in the arteries below my knees.
Select...
I am 22 years old or older.
Concerto Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in foot perfusion
Secondary outcome measures
Adverse Events
Subject Questionnaire
Concerto Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Activated TherapyExperimental Treatment1 Intervention
Therapy: these subjects will undergo 30 treatments with an activated Vibratosleeve TUS device.
Group II: Sham TherapyPlacebo Group1 Intervention
An inactive (sham) device will be used in these subjects for the first 30 treatments followed by a 30-treatment regimen with an activated VibratoSleeve TUS device after crossover.
Find a Location
Who is running the clinical trial?
Vascular and Interventional Specialists of Orange County, Inc. (VISOC)UNKNOWN
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
12 Patients Enrolled for Peripheral Arterial Disease
Vibrato Medical, Inc.Lead Sponsor
3 Previous Clinical Trials
36 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
36 Patients Enrolled for Peripheral Arterial Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a blockage in the arteries below my knees.I have no ulcers or skin issues on the back of my lower leg.I have not had a re-vascularization procedure in the last 25 days.I have had a deep vein clot in my leg below the knee.My leg pain is severe, affecting my quality of life.I have a severe long-term vein or mixed blood vessel condition.I have had a sudden loss of blood flow to a limb within the last month.Your diabetes is not well managed, and your HbA1c level is higher than 10%.I am currently receiving hyperbaric oxygen therapy.I am 22 years old or older.You have had a stent placed in certain leg arteries before.Your toe blood pressure is very low.
Research Study Groups:
This trial has the following groups:- Group 1: Activated Therapy
- Group 2: Sham Therapy
Awards:
This trial has 0 awards, including: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.
Are there any remaining spots available for participants in this trial?
"Affirmative. According to the information on clinicaltrials.gov, this study is currently enrolling participants; it was first posted on March 13th 2023 and last updated May 23rd 2023. This trial requires 30 patients at one medical site."
Answered by AI
What is the strictly enforced cap on participants for this research project?
"Affirmative. The information obtained from clinicaltrials.gov demonstrates that this trial, which was initially published on March 13th 2023, is currently enrolling patients. Approximately 30 individuals need to be recruited across 1 location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger