Chocolate Touch Device for Peripheral Arterial Disease

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of two balloon devices designed to open blocked arteries in the legs. The devices, Chocolate Touch and Lutonix Drug Coated Balloon, treat peripheral arterial disease, which causes leg pain due to poor blood flow. The trial involves two groups: one using the Chocolate Touch and the other using the Lutonix balloon. Individuals who frequently experience leg pain while walking or at rest due to artery blockages might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to medical research and potentially find relief from their symptoms.

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 prior data suggests that the Chocolate Touch device is safe for treating peripheral arterial disease?

Research has shown that the Chocolate Touch device, used to treat peripheral arterial disease, appears safe. Studies compared this device to the Lutonix Drug Coated Balloon, finding that the Chocolate Touch performed equally well and was not more harmful. However, there may be an increased risk of death occurring later after its use. This risk does not affect everyone, but researchers are monitoring it closely.

The Lutonix Drug Coated Balloon has been used in many treatments and is known for its safety. Discuss any concerns with a healthcare provider to determine the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Chocolate Touch device is unique for treating peripheral arterial disease because of its innovative balloon design that ensures gentle and uniform pressure distribution along the artery. Unlike traditional drug-coated balloons, the Chocolate Touch uses a nitinol constraining structure, which helps reduce vessel trauma and potentially enhances healing by minimizing dissections. Researchers are excited about this treatment as it may offer improved outcomes with fewer complications compared to conventional angioplasty options, providing a safer and more effective solution for patients.

What evidence suggests that the Chocolate Touch device is effective for peripheral arterial disease?

Research has shown that the Chocolate Touch device, which participants in this trial may receive, effectively treats peripheral arterial disease. In one study, 78.8% of patients using the Chocolate Touch device had open arteries after 12 months. This result matched the effectiveness of the Lutonix Drug Coated Balloon, another treatment option in this trial. Additionally, the Chocolate Touch improved blood flow in 72.5% of patients after 30 days, compared to 61.5% for the Lutonix group. Overall, these findings suggest that the Chocolate Touch can be a helpful treatment option. ^{1 2 4 5 6}

Who Is on the Research Team?

Thomas Zeller, MD

Principal Investigator

Universitat Herzzentrum, Bad Krozingen, Germany

Mehdi Shishehbor, DO

Principal Investigator

Cleveland Medical Center, Cleveland, Ohio

Are You a Good Fit for This Trial?

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.

My artery blockage is 70% or more in my thigh or knee area.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02924857

Study Details | NCT02924857 | The Chocolate Touch Study The primary objective of the Chocolate Touch study is to demonstrate non-inferior safety and non-inferior effectiveness of the Chocolate Touch™ compared to the ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/P210039B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The preclinical pharmacokinetic study demonstrated effective drug delivery and uptake into the arterial tissues at the therapeutic dose density ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.059646

Randomized Trial of Chocolate Touch Compared With ... Rates of ankle-brachial index improvement trended in favor of Chocolate Touch at 30 days: 72.5% versus 61.5% in the Lutonix DCB group (P=0.059).

4. acc.org acc.org/Latest-in-Cardiology/Articles/2022/04/03/13/22/Mon-11am-Paclitaxel-Coated-PTA-Balloon-Catheter-acc-2022

Chocolate Touch Device Superior to Lutonix in Efficacy, ... After 12 months, Chocolate Touch was found to be noninferior to Lutonix, with 78.8% of patients in the Chocolate Touch group achieving patency ...

5. uhhospitals.org uhhospitals.org/for-clinicians/articles-and-news/articles/2022/07/uh-harrington-heart-and-vascular-institute-president-leads-international-clinical-trial

UH Harrington Heart and Vascular Institute President ... Results at 12 months post-procedure show that Chocolate Touch was non-inferior to Lutonix, with 78.8 percent of Chocolate Touch patients ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/15/10/e103906

Safety and effectiveness of the Chocolate balloon catheter ... Introduction. In the management of peripheral arterial disease (PAD), conventional percutaneous transluminal angioplasty (PTA) is a widely adopted intervention.