Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis
NCT04240444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2023-11-14
Summary
This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects.
Conditions
- Coronary Artery Disease
- In Stent Restenosis
Interventions
- DEVICE
-
drug-coated balloon Catheter
All eligible subjects will be assigned randomly to study group or control group, receive PTCA.
Sponsors & Collaborators
-
CCRF Inc., Beijing, China
collaborator INDUSTRY -
B. Braun Medical International Trading Company Ltd.
lead INDUSTRY
Principal Investigators
-
Yaling Han, academician · The General Hospital of Northern Theater Command
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-10
- Primary Completion
- 2022-07-26
- Completion
- 2022-08-30
Countries
- China
Study Locations
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