To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
NCT04944615 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1448
Last updated 2023-03-29
Summary
This study aims to evaluate the treatment of Chronic total occlusion (CTO) disease. Whether Intravascular Ultrasonography (IVUS) guiding the implantation of drug-eluting stents (DES) will provide better long-term clinical outcomes compared with conventional angiography
Conditions
- Chronic Total Occlusion of Coronary Artery
Interventions
- PROCEDURE
-
The guidewire successfully passed the CTO lesion
The successful passage of the guide wire through the CTO lesion was defined as: the guide wire successfully passed through the CTO lesion and reached the distal true lumen as confirmed by angiography. Aspirin load dose (300 mg), clopidogrel load dose (300 mg), or ticagrelor load dose (180 mg) is recommended for all subjects prior to stent implantation and is recommended to be taken at least 6 hours prior to surgery.
Sponsors & Collaborators
-
BSC International Medical Trading (Shanghai) Co., Ltd.
collaborator OTHER -
CCRF Inc., Beijing, China
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-21
- Primary Completion
- 2031-10-31
- Completion
- 2031-10-31
Countries
- China
Study Locations
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