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IVUS-CTO: Comparison of the Effect of Intravascular Ultrasound-guided Versus Angiographic-guided Drug-eluting Stent Implantation on Long-term Clinical Outcomes in Patients With Chronic Complete Occlusion of Coronary Artery Disease: a Prospective, Multicenter, Randomized Controlled Clinical Study
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
The study was a prospective, multicenter, open-label, two-arm, 1:1 randomized controlled, well-designed clinical study. According to the sample size calculation, a total of 1448 patients with primary CTO lesions were required to participate in the study after the guide wire successfully passed through the lesion (defined as: angiographic indication that the guide wire successfully passed through the CTO lesion and reached the distal true lumen). The study will be conducted at no more than 45research centers. With competitive enrolment, a maximum of 500 patients can be enrolled at each center or until the study is completed, whichever comes first. It is recommended that each center enroll at least 20 patients.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
General Hospital of Shenyang Military Region
Beijing, China
Start Date
October 21, 2022
Primary Completion Date
October 1, 2031
Completion Date
October 1, 2031
Last Updated
March 29, 2023
1,448
ESTIMATED participants
The guidewire successfully passed the CTO lesion
PROCEDURE
Lead Sponsor
CCRF Inc., Beijing, China
Collaborators
NCT05813704
NCT07473596
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06543641