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Device
Chocolate Touch Device for Peripheral Arterial Disease
N/A
Waitlist Available
Led By Mehdi Shishehbor, DO
Research Sponsored by TriReme Medical, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intermittent claudication or ischemic rest pain (Rutherford 2-4)
Target Lesion ≤180mm that consists of no more than two adjacent lesions (≤ 25mm apart) and is able to be completely covered with inflation of no more than two assigned balloons (with minimum of >5mm overlap to the area covered by the first balloon). (Note: Adjacent or tandem target lesions must be treated as a single lesion.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 24, & 36 months
Awards & highlights
Study Summary
This trial is testing a new device to see if it is safe and effective for use in the arteries of the leg. If successful, the device could be approved for use in the US.
Who is the study for?
Adults over 18 with Peripheral Arterial Disease causing leg pain or rest pain, expected to live more than 2 years, and willing to follow the study plan. Participants must have a specific type of blockage in their leg arteries that can be treated with the study device and good blood flow below the knee. Pregnant women, those with recent heart attacks or strokes, severe kidney issues, bleeding disorders, certain allergies or who are in other studies cannot join.Check my eligibility
What is being tested?
The Chocolate Touch Study is testing a new device called Chocolate Touch against an existing treatment known as Lutonix Drug Coated Balloon. The goal is to see if Chocolate Touch is safe and effective for use in arteries above the knee. Patients will be randomly assigned to one of these treatments.See study design
What are the potential side effects?
While not specified here, typical side effects from procedures like this may include pain at the insertion site, bleeding, infection risk increase due to balloon catheter usage and potential reactions related to drug coatings such as Paclitaxel.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience leg pain from walking or at rest due to poor blood flow.
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My target lesion is small enough to be treated with two special balloons.
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I am 18 years old or older.
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My artery blockage is 70% or more in my thigh or knee area.
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My artery size fits the requirements for a specific treatment.
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My leg's main artery is open without major blockage to the ankle.
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My artery blockage is above the knee and not near the artery's start.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12, 24, & 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 24, & 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from Major Adverse Events
True Drug Coated Balloon Success
Secondary outcome measures
By Angiographic Core Lab Review (Acute)
By Clinical Assessment
By Duplex Ultrasound Core Lab Review
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Test Group (Chocolate Touch)Experimental Treatment1 Intervention
The diameter of the Chocolate Touch should correspond to the diameter of the vessel for treatment with a balloon to artery ratio of 1.1:1.
The Chocolate Touch must be inflated to at least nominal pressure. Maintain balloon inflation for a minimum of 2 minutes. The balloon may be inflated as long as required to achieve optimal angioplasty outcome.
If delivery is attempted and failed, a new Chocolate Touch should be used for subsequent attempts after pre-dilatation.
Group II: Control Group (Lutonix Drug Coated Balloon)Active Control1 Intervention
Never inflate the Lutonix® Drug Coated Balloon (DCB)prior to reaching the target lesion.
The Lutonix® Catheter should be advanced to the target site as fast as possible (i.e. 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio of >1:1).
If the deployment of the Lutonix® Catheter exceeds 3 minutes, the catheter requires placement with a new unit.
Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may be inflated as long as required by standard of care to achieve a good angioplasty outcome.
Find a Location
Who is running the clinical trial?
TriReme Medical, LLCLead Sponsor
5 Previous Clinical Trials
782 Total Patients Enrolled
Mehdi Shishehbor, DOPrincipal InvestigatorCleveland Medical Center, Cleveland, Ohio
1 Previous Clinical Trials
120 Total Patients Enrolled
Thomas Zeller, MDPrincipal InvestigatorUniversitat Herzzentrum, Bad Krozingen, Germany
14 Previous Clinical Trials
2,057 Total Patients Enrolled
2 Trials studying Intermittent Claudication
210 Patients Enrolled for Intermittent Claudication
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blocked artery in my limb or need clot-dissolving treatment.I have not had a heart attack or stroke in the last 30 days.I experience leg pain from walking or at rest due to poor blood flow.I have a surgery or medical procedure planned within 30 days after the study starts.I have not had certain specific treatments for non-target lesions.My target lesion is small enough to be treated with two special balloons.My kidney function is low, with a GFR ≤ 30 or creatinine >2.5mg/dL, or I am on dialysis.I have a bleeding disorder, am on dialysis, or have an uncontrolled blood clotting disorder.I have a stent or graft in my vessel, but it's not where my current issue is, and it doesn't block treatment access.I am 18 years old or older.A medical device was used to pass through the affected area.My artery blockage is 70% or more in my thigh or knee area.My artery size fits the requirements for a specific treatment.My leg's main artery is open without major blockage to the ankle.My blood vessels leading to the heart are mostly clear or successfully treated.My heart's blood vessel has severe hardening over a long area.I am not pregnant and do not plan to become pregnant during the study.My targeted blood vessel is damaged.You are expected to live for more than 2 years.My condition is not due to hardening of the arteries but could be inflammation or Berger's disease.I am allergic or cannot tolerate certain medications, dyes used in tests, nitinol, or Paclitaxel.My artery blockage is above the knee and not near the artery's start.
Research Study Groups:
This trial has the following groups:- Group 1: Test Group (Chocolate Touch)
- Group 2: Control Group (Lutonix Drug Coated Balloon)
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.
Are new participants still being enrolled for this research study?
"According to clinicaltrials.gov, this trial is at present not recruiting any participants; the initial posting was on July 26th 2017 and it has most recently been updated on December 21st 2020. Despite no longer searching for patients, 435 other trials are actively enrolling right now."
Answered by AI
How many facilities are involved with this trial's implementation?
"The current trial is accepting participants from Mid-Michigan Heart & Vascular in Saginaw, Michigan, Michigan Outpatient Vascular Institution in Dearborn, New jersey and Deborah Heart Browns Mills Ohio as well as twenty other institutions."
Answered by AI
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