Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)
NCT05447585 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 239
Last updated 2022-08-05
Summary
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary atherectomy system for the treatment of patients with coronary calcification.
Conditions
- Calcification of Coronary Artery
Interventions
- DEVICE
-
Coronary atherectomy system of Shanghai MicroPort Rhythm
Coronary Atherectomy System utilizes a diamond-coated eccentric crown to expand the lumen diameter via centrifugal forces while rotating over an atherectomy guide wire.
- DEVICE
-
Rotablator Rotational Atherectomy System
The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console
Sponsors & Collaborators
-
Shanghai MicroPort Rhythm MedTech Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianan Wang, M.D. · Second Affiliated Hospital, School of Medicine, Zhejiang University
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
- 2022-07-01
- Primary Completion
- 2023-12-10
- Completion
- 2024-12-10
Countries
- China
Study Locations
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