Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of Small Coronary Vessel Stenosis With a Common Coronary Balloon Catheter (Maverick2)
NCT02891005 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230
Last updated 2016-09-09
Summary
Study Purpose The safety and efficacy of paclitaxel controlled release balloon catheter VasoguardTM in treatment of small vessel lesion.
Study Group Experimental group: paclitaxel controlled release balloon catheter (VasoguardTM) Control group: common balloon catheter (Maverick2)
Conditions
- Small Vessel Lesion
Interventions
- DEVICE
-
paclitaxel controlled release balloon catheter (VasoguardTM)
paclitaxel controlled release balloon catheter implantation for small vessel lesion
- DEVICE
-
common balloon catheter (Maverick2)
common balloon catheter implantation for small vessel lesion
Sponsors & Collaborators
-
Shandong Branden Med.Device Co.,Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2017-12-31
Countries
- China
Study Locations
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