Chocolate Touch Device for Peripheral Arterial Disease

Recruiting at 29 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TriReme Medical, LLC

Must not be taking: Thrombolytics, Drug eluting stents

Disqualifiers: Acute limb ischemia, Myocardial infarction, Stroke, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 1 day

333 Participants Needed

Trial Summary

What is the purpose of this trial?

The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known intolerance to required medications or contrast media, you may not be eligible to participate.

What data supports the effectiveness of the Chocolate Touch treatment for peripheral arterial disease?

The Chocolate Touch drug-coated balloon was shown to be safe and more effective than the Lutonix drug-coated balloon for treating artery blockages in the legs of patients, including those with diabetes, over a 12-month period. ^{1 2 3 4 5}

Is the Chocolate Touch Device safe for humans?

The Chocolate Touch device, a type of drug-coated balloon, has been shown to be safe in studies for treating artery issues in the legs, with one study specifically noting its safety in patients with diabetes. The Lutonix drug-coated balloon, a similar device, has also been reviewed by the FDA for safety in treating artery blockages below the knee. ^{1 3 6 7 8}

How is the Chocolate Touch treatment different from other treatments for peripheral arterial disease?

The Chocolate Touch treatment is unique because it uses a special balloon that is constrained by nitinol, which helps reduce vessel trauma and prevent restenosis (re-narrowing of the artery) more effectively than traditional drug-coated balloons like the Lutonix. This design allows for better drug delivery and less need for additional stenting. ^{1 2 6 7 8}

Research Team

Thomas Zeller, MD

Principal Investigator

Universitat Herzzentrum, Bad Krozingen, Germany

Mehdi Shishehbor, DO

Principal Investigator

Cleveland Medical Center, Cleveland, Ohio

Eligibility Criteria

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.

Inclusion Criteria

I experience leg pain from walking or at rest due to poor blood flow.

My target lesion is small enough to be treated with two special balloons.

I am 18 years old or older.

Exclusion 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 have a surgery or medical procedure planned within 30 days after the study starts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with either the Chocolate Touch or Lutonix drug-coated balloon catheter

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits over 12 months

Long-term follow-up

Participants are monitored for long-term patency and adverse events

36 months

Treatment Details

Interventions

• Chocolate Touch
• Lutonix Drug Coated Balloon

Trial Overview 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.

Participant Groups

Group I: Test Group (Chocolate Touch) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

TriReme Medical, LLC

Lead Sponsor

Trials

6

Recruited

1,100+

Findings from Research

The Lutonix® drug coated balloon (DCB) is designed to improve blood flow in patients with atherosclerotic disease in the femoropopliteal region by delivering paclitaxel, a drug that helps prevent artery re-narrowing after treatment.

The FDA's advisory panel reviewed the DCB's premarket approval application based on a pivotal clinical trial comparing it to standard angioplasty, indicating strong support for its potential approval due to its promising efficacy in improving patency rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon. Escárcega, RO., Waksman, R.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Lutonix® 014 DCB global Below the Knee Registry Study: interim 6-month outcomes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Overview of the Virtual 2021 FDA's Circulatory System Devices Advisory Panel on Lutonix 014 Drug-Coated Percutaneous Transluminal Angioplasty Catheter for Below-the-Knee Lesions in Critical Limb Ischemia. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Sex-Related Outcomes Following Drug Balloon Angioplasty in Patients from the BIOLUX P-III Registry: A Subgroup Analysis. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Drug coated balloon with paclitaxel for the treatment of symptomatic peripheral artery disease: early and midterm results]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study). [2022]

7. France pubmed.ncbi.nlm.nih.gov

A novel constrained, paclitaxel-coated angioplasty balloon catheter. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon. [2014]