The Chocolate Touch Study

Study Overview
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Brief Summary
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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

Detailed Description
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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 Lutonix® drug coated balloon catheter. These data are intended to show safety and effectiveness of the Chocolate Touch sufficient to support regulatory approval to market this device in the United States for use in superficial femoral or popliteal arteries. Study success is defined as statistical demonstration of the non-inferiority hypothesis tests for both the primary safety and effectiveness hypothesis. PMA P210039 approval has been granted on 11/04/2022. The study is now in the post-approval phase.

Official Title
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A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions

Conditions
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Peripheral Artery Disease (PAD), Ischemia, Intermittent Claudication

Intervention / Treatment
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* Device: Chocolate Touch
* Device: Lutonix Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria General: Minimum of 18 years of age Intermittent claudication or ischemic rest pain (Rutherford 2-4) Life Expectancy >2 years Patient has agreed to follow-up requirements and given informed consent Angiographic: Lesion successfully crossed with a guidewire Lesion in the SFA or popliteal artery defined as a lesion with a proximal origin >10 mm from SFA origin (deep femoral artery) and a distal end above the knee joint (at least 3 cm above bottom of the femur - P1). Target Lesion ≥70% stenosis in the SFA or popliteal arteries Reference Vessel Diameter (RVD) between 4.0 & 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at the Target Lesion 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.) Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (≥70%) stenosis from origin to ankle In-flow vessel without significant stenosis (≥70%) or successful treatment (≤30% residual stenosis with no complications) of a diseased vessel. Note: treatment of contralateral iliac is permissible. Exclusion Criteria General: Acute limb ischemia, or patient indicated for thrombolytic therapy Planned surgical or interventional procedures within 30 days after study procedure. 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. Myocardial infarction or stroke within 30 days prior to the procedure Known intolerance to required medications, contrast media that cannot be adequately premedicated, nitinol, or Paclitaxel Known impaired Renal Function that could have an impact on contrast tolerance with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on dialysis. Known bleeding disorder, or on dialysis, or uncontrolled hypercoagulable disorder Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease) Female who is pregnant or intends to be pregnant during study Patient is enrolled in another investigational clinical study or was previously enrolled in this study Angiographic: Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment Severe Calcification at the target lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends >50 continuous mm in length). Previous bypass graft, stent at target vessel (must be greater than 20mm from target lesion), or iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath (Note: In-stent restenosis is not allowed.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group (Chocolate Touch)<br>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. | Device: Chocolate Touch<br>* The Chocolate Touch™ Paclitaxel Coated Balloon Catheter is indicated for balloon dilatation, after appropriate vessel preparation as needed, of lesions in native superficial femoral or popliteal arteries up to 18 cm in length that are appropriate for angioplasty with balloon diameters from 3.5 mm to 6.0mm.<br>* Other names: Chocolate Touch™ Paclitaxel Coated Balloon Catheter;|
| Active Comparator: Control Group (Lutonix Drug Coated Balloon)<br>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. | Device: Lutonix Drug Coated Balloon<br>* The Lutonix® 035 Drug Coated Balloon Catheter is indicated for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 18 cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm.<br>* Other names: LUTONIX® 035 Drug Coated Balloon Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True Drug Coated Balloon Success | A composite endpoint that requires patients to achieve Primary Patency (Peak systolic velocity ratio <2.4 without the need for clinically driven target lesion revascularization) in the absence of a clinically driven bail-out stent (core lab adjudicated). | 12 months | 
| Freedom from Major Adverse Events | Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| By Angiographic Core Lab Review (Acute) | Procedural Success: Defined as the success of the therapy to achieve <30% diameter stenosis without a flow-limiting dissection or the need for a stent | 1 hour | 
| By Duplex Ultrasound Core Lab Review | Patency | 6, 12, 24, & 36 months | 
| By Clinical Assessment | Occurrence of relevant Adverse Events | 6, 12, 24, & 36 months |