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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02924857




Registration number
NCT02924857
Ethics application status
Date submitted
3/10/2016
Date registered
5/10/2016

Titles & IDs
Public title
The Chocolate Touch Study
Scientific title
A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions
Secondary ID [1] 0 0
CLP788
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease (PAD) 0 0
Ischemia 0 0
Intermittent Claudication 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Chocolate Touch
Treatment: Devices - Lutonix Drug Coated Balloon

Experimental: Test Group (Chocolate Touch) - * 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.

Active comparator: Control Group (Lutonix Drug Coated Balloon) - * 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.


Treatment: Devices: Chocolate Touch
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.

Treatment: Devices: Lutonix Drug Coated Balloon
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
True Drug Coated Balloon Success
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Freedom from Major Adverse Events
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
By Angiographic Core Lab Review (Acute)
Timepoint [1] 0 0
1 hour
Secondary outcome [2] 0 0
By Duplex Ultrasound Core Lab Review
Timepoint [2] 0 0
6, 12, 24, & 36 months
Secondary outcome [3] 0 0
By Clinical Assessment
Timepoint [3] 0 0
6, 12, 24, & 36 months

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
Accrual to date
Final
333
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Austria
State/province [12] 0 0
Graz
Country [13] 0 0
Austria
State/province [13] 0 0
Vienna
Country [14] 0 0
Germany
State/province [14] 0 0
Bad Krozingen
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
New Zealand
State/province [16] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TriReme Medical, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mehdi Shishehbor, DO
Address 0 0
Cleveland Medical Center, Cleveland, Ohio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02924857