NCT04944615

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.

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,448 (estimated)
• Sponsor: CCRF Inc., Beijing, China · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Chronic Total Occlusion of Coronary Artery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-21
• Primary completion: 2031-10-01
• Completion: 2031-10-01
• First posted: 2021-06-29
• Last updated: 2023-03-29

Locations

1 site across 1 country: China