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. (CRUISE-CTO)

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Procedure: The guidewire successfully passed the CTO lesion

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 Type: Interventional
• Enrollment (Anticipated): 1448
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • General Hospital of Shenyang Military Region
    • Contact: Yaling Han; Phone Number: 008602428856577; Email: szec2005@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Clinical inclusion criteria:

1. At least 18 years old
2. Subjects will understand the test requirements, treatment and surgery, and can provide written informed consent
3. Subjects with clinical symptoms of ischemic heart disease or evidence of myocardial ischemia associated with CTO target vessels and scheduled to undergo Percutaneous coronary intervention (PCI)
4. Subjects will receive percutaneous coronary intervention
5. Subjects are willing to accept all treatment and follow-up evaluations required by the protocol

Inclusion criteria for angiography:

1. Primary coronary artery CTO lesion with visible collateral circulation
2. Estimation of the time to complete occlusion (TIMI grade 0) ≥3 months based on clinical history and/or comparison with historical angiography or ECG
3. It is suitable for target lesions of 2.25-4.0mm stent implantation
4. The length of CTO lesion should be greater than 20mm

Clinical exclusion criteria:

1. Pregnant and lactating women
2. Severe coronary artery disease, not suitable for PCI
3. Patients with acute myocardial infarction less than 7 days
4. Long-term contraindications to DAPT (at least 1 year)
5. Known renal insufficiency.20 mL/min / 1.73 ㎡)
6. Left ventricular ejection fraction <35% or cardiogenic shock
7. The ICD implanted/CRT
8. Severe bleeding or stroke within 6 months
9. Have a history of allergy to iodine contrast agents or any known allergy to clopidogrel, ticagrelor, aspirin, or heparin
10. Subjects have been diagnosed or suspected of liver disease, including laboratory evidence of hepatitis
11. Valvular heart disease significantly affecting hemodynamics, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
12. Diseases that researchers believe may seriously harm patients, such as cancer and mental illness;Or the patient's life expectancy is less than one year and the follow-up cannot be completed;Or other conditions that researchers think might have confounded the results
13. Participate in any other ongoing trial or intend to participate in another clinical trial of a drug or device within 12 months after baseline surgery

Angiographic exclusion criteria:

1. The target lesion is located in the left main artery
2. No visible collateral circulation in CTO lesions
3. Target lesion is venous or arterial bypass graft
4. The target vessel occlusion time (TIMI grade 0) < 3 months can be determined

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Load dose administration
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.	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.; Other Names: Load dose administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	All causes of death, myocardial infarction, stent thrombosis (ARC clear/probable), and clinically driven target vessel revascularization	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiogenic death	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.	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Nonfatal myocardial infarction	Nonfatal myocardial infarction	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Target lesion revascularization	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.	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Target vessel revascularization	Target vessel revascularization is defined as repeated intervention in the vessel where the target lesion is located in reference to target lesion revascularization	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Target lesion failure	Target lesion failure refers to target lesion revascularization, target vascular-related MI (Q wave and non-Q wave) or (cardiac) death due to ischemia	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Target vessel failure	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	30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Left ventricular function improved	Left ventricular ejection fraction at 1 year and changes from baseline to 1 year	Baseline period and one-year follow-up period
Percentage stenosis of segmental and stent diameter	Anangiographic percentage of insegment and instent diameter stenosis measured by QCA at 12 months postoperatively	The follow-up period was 12 months
Lumens in segmental vessels and stents were lost	12 months postoperatively, angiographic measurements of intrasegmental and in-stent lumens by QCA were lost	The follow-up period was 12 months
Binary restenosis rate in segment and stent	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	The follow-up period was 12 months
Minimum lumen diameters in segments and stents	Minimum lumen diameters in segmental vessels and stents as measured by QCA 12 months postoperatively	The follow-up period was 12 months
QCA measurements were obtained immediately in the lumen	Immediate luminal measurements of QCA during surgery were obtained	Baseline operative period
MLD measured by QCA	MLD measured by QCA during surgery	Baseline operative period
Clinical success rate	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	Baseline operative period

Collaborators and Investigators

• Sponsor: CCRF Inc., Beijing, China
• Collaborators: BSC International Medical Trading (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Anticipated): October 1, 2031
• Study Completion (Anticipated): October 1, 2031

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: TIMI flow = grade 0 coronary artery disease with a duration greater than 3 months.
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No