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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Primary coronary artery CTO lesion with visible collateral circulation
• Estimation of the time to complete occlusion (TIMI grade 0) ≥3 months based on clinical history and/or comparison with historical angiography or ECG
• It is suitable for target lesions of 2.25-4.0mm stent implantation
• The length of CTO lesion should be greater than 20mm
Locations
Other Locations
China
General Hospital of Shenyang Military Region
RECRUITING
Beijing
Time Frame
Start Date: 2022-10-21
Estimated Completion Date: 2031-10
Participants
Target number of participants: 1448
Treatments
Experimental: Intravascular ultrasound guidance
All targeted CTO lesions will be examined and documented using a commercially available IVUS catheter (Opticross HD) according to its instructions (if not contraindicated, preoperative vasodilation with nitroglycerin to prevent spasm).~IVUS examination must be performed at least once before and after stent implantation.
Active_comparator: Angiographic guidance
The patient will choose the appropriate length and diameter of the stent to be implanted by visual estimation. All commercially available drug-eluting stents (except first-generation DES, such as Taxus, Excel, Partner, Firebird, etc.) can be used. DES with high quality clinical evidence is strongly recommended. The type, diameter, and length of the stent are determined by the surgeon. The stent length should be selected to ensure complete coverage of the CTO lesion. If dissection is present, additional stents are implanted. Repeat angiograms were performed immediately after surgery in the same view as before surgery.
Related Therapeutic Areas
Sponsors
Leads: CCRF Inc., Beijing, China
Collaborators: BSC International Medical Trading (Shanghai) Co., Ltd.