Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)

Sponsor
First People's Hospital of Hangzhou
Study ID
NCT06933992
Status
Enrolling By Invitation

Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Chocolate PTA Balloon Catheter — DEVICE
    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.

Study Details

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

Key Dates

First listed
Apr 18, 2025
Start date
Jul 20, 2025
Status verified
Apr 2025
Primary completion
Jul 20, 2027
Completion
Dec 20, 2027

Study Design

Enrollment
171 participants (estimated)

Arms

  • Arm: Chocolate PTA for PAD
    This cohort comprises patients with symptomatic peripheral artery disease (Rutherford class 2-5) undergoing percutaneous transluminal angioplasty (PTA) using the Chocolate balloon catheter as part of routine care. Participants will be prospectively followed for 12 months to assess target lesion patency, revascularization rates, and clinical outcomes. Inclusion criteria: age ≥18 years, de novo/restenotic lesions (≤150 mm) in native lower limb arteries, and reference vessel diameter 4-6 mm.

Primary Outcome Measure

Target lesion patency rate at 12 months post-procedure [ Time Frame: From enrollment to the end of treatment at 12 months ]

Related Studies