Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis
NCT03401203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2023-01-04
Summary
This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.
Conditions
- Coronary Vessels
Interventions
- PROCEDURE
-
Rotational atherectomy followed by balloon angioplasty
Percutaneous coronary intervention
- PROCEDURE
-
Balloon angioplasty
Percutaneous coronary intervention
Sponsors & Collaborators
-
CardioVascular Research Foundation, Korea
collaborator OTHER -
Seung-Jung Park
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-08
- Primary Completion
- 2022-12-01
- Completion
- 2022-12-31
Countries
- South Korea
Study Locations
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