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Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)
Sponsor: First People's Hospital of Hangzhou
Summary
This study aims to learn about the long-term safety and effectiveness of the Chocolate Balloon Catheter in patients with blocked leg arteries (peripheral artery disease, or PAD). The Chocolate Balloon is a special type of balloon used during minimally invasive procedures to open narrowed arteries while potentially causing less damage to the blood vessel. The main question it aims to answer is: Does the Chocolate Balloon keep the treated artery open after 12 months without needing repeat procedures? Patients with PAD who are already scheduled to undergo an artery-opening procedure (angioplasty) with the Chocolate Balloon as part of their standard care will answer the question about the safety and effectiveness of the Chocolate Balloon Catheter
Official title: Evaluation of the Safety and Efficacy of the Chocolate Balloon Catheter in Percutaneous Transluminal Angioplasty (PTA) for Peripheral Arterial Disease (PAD): A Prospective, Multicenter, Single-Arm Observational Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
171
Start Date
2025-07-20
Completion Date
2027-12-20
Last Updated
2025-04-18
Healthy Volunteers
No
Conditions
Interventions
Chocolate PTA Balloon Catheter
The Chocolate PTA balloon catheter is a nitinol-constrained percutaneous transluminal angioplasty balloon designed to minimize vessel trauma during treatment of peripheral arterial lesions. The device is used according to its standard indications and instructions for use in patients with symptomatic peripheral artery disease.
Locations (1)
Hangzhou First People's Hospital
Hangzhou, China