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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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The Chocolate Touch Continued Follow-up Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P210039 / PAS001
Date Original Protocol Accepted 11/04/2022
Date Current Protocol Accepted  
Study Name The Chocolate Touch Continued Follow-up Study
Device Name Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives To show sufficient long term safety and effectiveness of the Chocolate Touch® for use in superficial femoral or popliteal arteries.

The Chocolate Touch Study was designed as a global, multicenter, single blind, randomized (1:1 Chocolate Touch DCB to Lutonix DCB) trial.

This study is continued follow-up of premarket cohorts.
Study Population Adult patients with PAD
Sample Size 313 patients enrolled
Key Study Endpoints The primary effectiveness endpoint is true DCB success of the target lesion, defined as a composite of 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).

The primary safety endpoint is a composite of freedom from major adverse events (MAE), defined as a composite of target limb-related death, major amputation of the target limb, and re-intervention of the target limb.

The endpoints to be assessed through 3 years post-procedure are rate of: (1) major adverse events (MAE), (2) VIVA safety endpoint, (3) true DCB success, (4) clinically-driven target lesion revascularization (CD-TLR), (5) all TLR, (6) primary patency, (7) major amputation, and (8) clinical improvement. Mortality is to be assessed through 5 years post-procedure
Follow-up Visits and Length of Follow-up 5 years


The Chocolate Touch Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 11/17/2023 11/17/2023 On Time
2 year report 11/03/2024    
3 year report 11/03/2025    
4 year report 11/03/2026    
5 year report 11/03/2027    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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