MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
NCT02400632 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2020-03-17
Summary
The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.
Conditions
Interventions
- DEVICE
-
MAGIC-TOUCH Drug-eluting Balloon
in-stent restenosis treated with drug eluting balloon
Sponsors & Collaborators
-
Scitech Produtos Medicos Ltda
lead INDUSTRY
Principal Investigators
-
Alexandre Abizaid, PhD · Instituto Dante Pazzanese de Cardiologia
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2019-07-30
- Completion
- 2019-12-30
Countries
- Brazil
Study Locations
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