Coronary Crossing System in Patients With Coronary Chronic Total Occlusions
NCT05813704 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2024-03-18
Summary
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.
Conditions
- Chronic Total Occlusion of Coronary Artery
Interventions
- DEVICE
-
Coronary Crossing System of Shanghai MicroPort Rhythm
The mechanical vibration generated by the Coronary Crossing System through the piezoelectric effect is amplified and transmitted to the distal end of the guidewire to achieve high-frequency vibration at the tip of the guidewire, and then achieve efficient and safe penetration of the fibrous cap of the CTO.
Sponsors & Collaborators
-
Shanghai Zhongshan Hospital
collaborator OTHER -
Xiamen Cardiovascular Hospital, Xiamen University
collaborator OTHER -
Shanghai Baoshan District Wusong Central Hospital
collaborator UNKNOWN -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
collaborator OTHER -
The First Affiliated Hospital of Nanchang University
collaborator OTHER -
First Affiliated Hospital Xi'an Jiaotong University
collaborator OTHER -
First Affiliated Hospital of Wenzhou Medical University
collaborator OTHER -
Tianjin First Central Hospital
collaborator OTHER -
The Affiliated Hospital Of Southwest Medical University
collaborator OTHER -
Hebei General Hospital
collaborator OTHER -
West China Hospital
collaborator OTHER -
First Affiliated Hospital of Army Medical University, PLA
collaborator UNKNOWN -
Lanzhou University First Hospital
collaborator UNKNOWN -
Nanfang Hospital, Southern Medical University
collaborator OTHER -
The Second Affiliated Hospital of Dalian Medical University
collaborator OTHER -
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Shanghai MicroPort Rhythm MedTech Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Junbo Ge, M.D. · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-07
- Primary Completion
- 2025-04-30
- Completion
- 2025-05-31
Countries
- China
Study Locations
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