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.

Not Applicable

Recruiting

• Conditions: Chronic Total Occlusion of Coronary Artery

• Registration Number: NCT04944615
• Lead Sponsor: CCRF Inc., Beijing, China

Brief 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.

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-29
• Study Start: 2022-10-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2031-10
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1448

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	The study design was event-driven. When a predetermined number of primary endpoints (number of MACE events = 291) occurs (expected 3 years), the study termination procedure will be initiated and this data will be used for primary end point analysis.	All causes of death, myocardial infarction, stent thrombosis (ARC clear/probable), and clinically driven target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
Left ventricular function improved	Baseline period and one-year follow-up period	Left ventricular ejection fraction at 1 year and changes from baseline to 1 year
Percentage stenosis of segmental and stent diameter	The follow-up period was 12 months	Anangiographic percentage of insegment and instent diameter stenosis measured by QCA at 12 months postoperatively
Clinical success rate	Baseline operative period	Clinical success was defined by visual evaluation of mean lesion diameter stenosis by the physician on 2 near-orthogonal projection angiography with TIMI blood flow grade 3.; No nosocomial myocardial infarction, TVR or cardiac death occurred in 30% of patients
Cardiogenic death	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery	This includes acute myocardial infarction, cardiac perforation/tamponade, arrhythmia or conduction abnormalities, cerebrovascular accidents at discharge or suspected operating-related cerebrovascular accidents, death from surgical complications, including hemorrhage, vascular repair, transfusion reaction, or bypass surgery, or any death of cardiac origin that cannot be ruled out.
Binary restenosis rate in segment and stent	The follow-up period was 12 months	Binary restenosis refers to the previously treated stenosis diameter at the lesion site \> 50%, including the original treatment area and proximal and distal areas adjacent to the QCA analysis segment
Minimum lumen diameters in segments and stents	The follow-up period was 12 months	Minimum lumen diameters in segmental vessels and stents as measured by QCA 12 months postoperatively
Nonfatal myocardial infarction	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery	Nonfatal myocardial infarction
Target vessel revascularization	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery	Target vessel revascularization is defined as repeated intervention in the vessel where the target lesion is located in reference to target lesion revascularization
Target vessel failure	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery	Target vessel failure refers to target vessel revascularization, target-related MI (Q wave and non-Q wave), or target-related (cardiac) death resulting from ischemia
QCA measurements were obtained immediately in the lumen	Baseline operative period	Immediate luminal measurements of QCA during surgery were obtained
Target lesion failure	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery	Target lesion failure refers to target lesion revascularization, target vascular-related MI (Q wave and non-Q wave) or (cardiac) death due to ischemia
Target lesion revascularization	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery	Target lesion revascularization is any ischemia-driven repetitive percutaneous coronary intervention to improve blood flow to a successfully treated target lesion or to bypass the target vessel and use a graft distally to the successfully treated target lesion.; If the target lesion diameter is ≥50% stenosis as assessed by QCA and there is clinical or functional ischemia that cannot be explained by other coronary or graft lesions, vascularization will be considered to be induced by ischemia.
MLD measured by QCA	Baseline operative period	MLD measured by QCA during surgery
Lumens in segmental vessels and stents were lost	The follow-up period was 12 months	12 months postoperatively, angiographic measurements of intrasegmental and in-stent lumens by QCA were lost

Trial Locations

Locations (1)

General Hospital of Shenyang Military Region; 🇨🇳 Beijing, China