The Chocolate Touch Study
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|ClinicalTrials.gov Identifier: NCT02924857|
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Claudication Ischemia||Device: Chocolate Touch Device: Lutonix Drug Coated Balloon||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||585 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions|
|Actual Study Start Date :||July 26, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2026|
Experimental: Test Group (Chocolate Touch)
Device: 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.
Other Name: Chocolate Touch™ Paclitaxel Coated Balloon Catheter
Active Comparator: Control Group (Lutonix Drug Coated Balloon)
Device: 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.
Other Name: LUTONIX® 035 Drug Coated Balloon Catheter
- True Drug Coated Balloon Success [ Time Frame: 12 months ]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 [ Time Frame: 12 months ]Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb.
- By Angiographic Core Lab Review (Acute) [ Time Frame: 1 hour ]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 [ Time Frame: 6, 12 & 24 months ]Patency
- By Clinical Assessment [ Time Frame: 1, 6, 12, & 24 months ]Occurrence of relevant Adverse Events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924857
|Contact: Kristine Orosz, BS||925-931-1300 ext email@example.com|
|Principal Investigator:||Mehdi Shishehbor, DO||Cleveland Medical Center, Cleveland, Ohio|
|Principal Investigator:||Thomas Zeller, MD||Universitat Herzzentrum, Bad Krozingen, Germany|