Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter
NCT02891018 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2016-09-09
Summary
Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter Vasoguard TM in treatment of in-stent restenosis.
Study group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM Control group: paclitaxel release coronary balloon catheter SeQuent Please
Conditions
- In-stent Restenosis
Interventions
- DEVICE
-
paclitaxel controlled release balloon catheter Vasoguard TM
- DEVICE
-
paclitaxel release coronary balloon catheter SeQuent Please
Sponsors & Collaborators
-
Fudan University
collaborator OTHER -
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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