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Device

Chocolate Touch Device for Peripheral Arterial Disease

N/A

Waitlist Available

Led By Thomas Zeller, MD

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.)

Must not have

Acute limb ischemia, or patient indicated for thrombolytic therapy

Non-target lesion concurrent interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or, treatment with any other drug coated balloon

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, 24, & 36 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blocked artery in my limb or need clot-dissolving treatment.

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I have not had certain specific treatments for non-target lesions.

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My kidney function is low, with a GFR ≤ 30 or creatinine >2.5mg/dL, or I am on dialysis.

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I have a bleeding disorder, am on dialysis, or have an uncontrolled blood clotting disorder.

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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.

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My heart's blood vessel has severe hardening over a long area.

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I am not pregnant and do not plan to become pregnant during the study.

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My targeted blood vessel is damaged.

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My condition is not due to hardening of the arteries but could be inflammation or Berger's disease.

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I am allergic or cannot tolerate certain medications, dyes used in tests, nitinol, or Paclitaxel.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 24, & 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Freedom from Major Adverse Events

True Drug Coated Balloon Success

Secondary study objectives

By Angiographic Core Lab Review (Acute)

By Clinical Assessment

By Duplex Ultrasound Core Lab Review

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 17Eligibility criteria met