Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia
NCT04017364 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2021-08-27
Summary
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
Conditions
Interventions
- DEVICE
-
PCB PTCA
Predilatation of coronary de-novo stenosis followed by a PCB
- DEVICE
-
SCB PTCA
Predilatation of coronary de-novo stenosis followed by a SCB
Sponsors & Collaborators
-
InnoRa GmbH
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-01
- Primary Completion
- 2020-08-30
- Completion
- 2021-01-31
Countries
- Malaysia
Study Locations
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