Back to resultsThe Chocolate Touch Study
Primary Purpose
Intermittent Claudication, Ischemia
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Chocolate Touch
Lutonix Drug Coated Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication
Eligibility Criteria
Inclusion Criteria:
- 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
- Lesion successfully crossed with a guidewire
- Lesion in the superficial femoral or popliteal artery
- Target lesion >70% stenosis
- Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at Target Lesion
- Target Lesion <18cm 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
- Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (>70%) stenosis from origin to to ankle
- In-flow vessel without significant stenosis (<70%) or successful treatment (<30% residual stenosis with no complications) of a diseased iliac vessel
Exclusion Criteria:
- Acute limb ischemia, or patient indicated for thrombolytic therapy
- Planned surgery within 30 days including interventions on the non-target limb
- Target Limb 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, nitinol, or Paclitaxel
- Known impaired Renal Function that could have an impact on contrast tolerance with Glomerular filtration rate (GFR) ≤ 30 ml/min per 1.73 m^2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L)
- Known bleeding disorder 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 clinical study or was previously enrolled in this study
- Presence of perforation, dissection or other injury at access site or 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 >5 continuous cm in length)
- Previous bypass graft or stent at target vessel, OR, iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath
Sites / Locations
- Cardiac and Vascular Institute
- Mt. Sinai - Miami
- Emory University
- Alexian Brothers
- Cardiovascular Institute of the South
- Michigan Outpaitient Vascular Institution
- Mid-Michigan Heart & Vascular
- Jackson Heart
- St. Luke's Hospital
- Deborah Heart
- Mt. Sinai Heart
- Columbia University Medical Center / NewYork Presbyterian Hospital
- Univeristy Hospitals Cleveland Medical Center
- Holy Spirit Cardiovascular Institute
- Pinnacle Health Cardiovascular Institute
- Lankenau Medical Center
- Wellmont CVA Heart Institute
- Hurricane Cardiology
- MIssion Research
- Swedish Medical Center
- LKH Univ. Klinikum Graz
- Medical University of Graz
- Angiologie - Hansuchkrankenhaus
- Universitat Herz-Zentrum
- Leipzig University
- Auckland City Hospital
- Waikato Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Group (Chocolate Touch)
Control Group (Lutonix Drug Coated Balloon)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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
By Duplex Ultrasound Core Lab Review
Patency
By Clinical Assessment
Occurrence of relevant Adverse Events
Full Information
NCT ID
NCT02924857
First Posted
October 3, 2016
Last Updated
December 21, 2020
Sponsor
TriReme Medical, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02924857
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriReme Medical, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
585 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Group (Chocolate Touch)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (Lutonix Drug Coated Balloon)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Chocolate Touch
Other Intervention Name(s)
Chocolate Touch™ Paclitaxel Coated Balloon Catheter
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Lutonix Drug Coated Balloon
Other Intervention Name(s)
LUTONIX® 035 Drug Coated Balloon Catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
True Drug Coated Balloon Success
Description
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).
Time Frame
12 months
Title
Freedom from Major Adverse Events
Description
Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
By Angiographic Core Lab Review (Acute)
Description
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
Time Frame
1 hour
Title
By Duplex Ultrasound Core Lab Review
Description
Patency
Time Frame
6, 12 & 24 months
Title
By Clinical Assessment
Description
Occurrence of relevant Adverse Events
Time Frame
1, 6, 12, & 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Lesion successfully crossed with a guidewire
Lesion in the superficial femoral or popliteal artery
Target lesion >70% stenosis
Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at Target Lesion
Target Lesion <18cm 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
Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (>70%) stenosis from origin to to ankle
In-flow vessel without significant stenosis (<70%) or successful treatment (<30% residual stenosis with no complications) of a diseased iliac vessel
Exclusion Criteria:
Acute limb ischemia, or patient indicated for thrombolytic therapy
Planned surgery within 30 days including interventions on the non-target limb
Target Limb 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, nitinol, or Paclitaxel
Known impaired Renal Function that could have an impact on contrast tolerance with Glomerular filtration rate (GFR) ≤ 30 ml/min per 1.73 m^2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L)
Known bleeding disorder 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 clinical study or was previously enrolled in this study
Presence of perforation, dissection or other injury at access site or 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 >5 continuous cm in length)
Previous bypass graft or stent at target vessel, OR, iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi Shishehbor, DO
Organizational Affiliation
Cleveland Medical Center, Cleveland, Ohio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Zeller, MD
Organizational Affiliation
Universitat Herzzentrum, Bad Krozingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac and Vascular Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Mt. Sinai - Miami
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Alexian Brothers
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Michigan Outpaitient Vascular Institution
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Mid-Michigan Heart & Vascular
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Jackson Heart
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Deborah Heart
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Mt. Sinai Heart
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center / NewYork Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univeristy Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Holy Spirit Cardiovascular Institute
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Wellmont CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Hurricane Cardiology
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
MIssion Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
LKH Univ. Klinikum Graz
City
Graz
ZIP/Postal Code
A-0836
Country
Austria
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Facility Name
Angiologie - Hansuchkrankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Universitat Herz-Zentrum
City
Bad Krozingen
Country
Germany
Facility Name
Leipzig University
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3210
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
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The Chocolate Touch Study
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