Last updated on September 2018

The Chocolate Touch Study


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02924857

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Jackson Heart

Jackson, MS United States
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New York, NY United States
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Browns Mills, NJ United States
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Elk Grove Village, IL United States
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Gainesville, FL United States
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Kingsport, TN United States
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Miami Beach, FL United States
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Atlanta, GA United States
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Kansas City, MO United States
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Wynnewood, PA United States
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New Braunfels, TX United States
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MIssion Research

New Braunfels, TX United States
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Swedish Medical Center

Seattle, WA United States
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Waikato Hospital

Hamilton, New Zealand
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