Clinical trial NCT02924857: The Chocolate Touch Study
Official title: A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease (PAD)
Ischemia
Intermittent Claudication
Lead sponsor: TriReme Medical, LLC
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria

General:

1. Minimum of 18 years of age
2. Intermittent claudication or ischemic rest pain (Rutherford 2-4)
3. Life Expectancy \>2 years
4. Patient has agreed to follow-up requirements and given informed consent

   Angiographic:
5. Lesion successfully crossed with a guidewire
6. 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).
7. Target Lesion ≥70% stenosis in the SFA or popliteal arteries
8. 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
9. 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.)
10. Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (≥70%) stenosis from origin to ankle
11. 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:

1. Acute limb ischemia, or patient indicated for thrombolytic therapy
2. Planned surgical or interventional procedures within 30 days after study procedure.
3. 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.
4. Myocardial infarction or stroke within 30 days prior to the procedure
5. Known intolerance to required medications, contrast media that cannot be adequately premedicated, nitinol, or Paclitaxel
6. 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.
7. Known bleeding disorder, or on dialysis, or uncontrolled hypercoagulable disorder
8. Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
9. Female who is pregnant or intends to be pregnant during study
10. Patient is enrolled in another investigational clinical study or was previously enrolled in this study

    Angiographic:
11. Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment
12. 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).
13. 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.)

Primary outcomes:
measure: True Drug Coated Balloon Success
timeFrame: 12 months
measure: Freedom from Major Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: By Angiographic Core Lab Review (Acute)
timeFrame: 1 hour
measure: By Duplex Ultrasound Core Lab Review
timeFrame: 6, 12, 24, & 36 months
measure: By Clinical Assessment
timeFrame: 6, 12, 24, & 36 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Cardiac and Vascular Institute
state: Florida
city: Miami Beach
country: United States
facility: Mt. Sinai - Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Dearborn
country: United States
facility: Michigan Outpaitient Vascular Institution
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: New York
country: United States
facility: Mt. Sinai Heart
state: New York
city: New York
country: United States
facility: Columbia University Medical Center / NewYork Presbyterian Hospital
state: New York
city: Cleveland
country: United States
facility: Univeristy Hospitals Cleveland Medical Center
state: Ohio
city: Camp Hill
country: United States
facility: Penn State Health Holy Spirit Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: New Braunfels
country: United States
facility: MIssion Research
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Graz
country: Austria
facility: Medical University of Graz - LKH Univ.-Klinikum Graz
city: Vienna
country: Austria
facility: Angiologie - Hansuchkrankenhaus
city: Bad Krozingen
country: Germany
facility: Universitat Herz-Zentrum
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
affiliation: Cleveland Medical Center, Cleveland, Ohio
name: Mehdi Shishehbor, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Herzzentrum, Bad Krozingen, Germany
name: Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
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