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.

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Major adverse cardiac events [Time frame: 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 (12)

• Cardiogenic death [Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery]
• Nonfatal myocardial infarction [Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery]
• Target lesion revascularization [Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery]
• Target vessel revascularization [Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery]
• Target lesion failure [Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery]
• Target vessel failure [Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery]
• Left ventricular function improved [Time frame: Baseline period and one-year follow-up period]
• Percentage stenosis of segmental and stent diameter [Time frame: The follow-up period was 12 months]
• Lumens in segmental vessels and stents were lost [Time frame: The follow-up period was 12 months]
• Binary restenosis rate in segment and stent [Time frame: The follow-up period was 12 months]
• Minimum lumen diameters in segments and stents [Time frame: The follow-up period was 12 months]
• QCA measurements were obtained immediately in the lumen [Time frame: Baseline operative period]

Eligibility criteria

Clinical inclusion criteria:

• At least 18 years old
• Subjects will understand the test requirements, treatment and surgery, and can provide written informed consent
• 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)
• Subjects will receive percutaneous coronary intervention
• Subjects are willing to accept all treatment and follow-up evaluations required by the protocol

Inclusion criteria for angiography:

• 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

Clinical exclusion criteria:

• Pregnant and lactating women
• Severe coronary artery disease, not suitable for PCI
• Patients with acute myocardial infarction less than 7 days
• Long-term contraindications to DAPT (at least 1 year)
• Known renal insufficiency.20 mL/min / 1.73 ㎡)
• Left ventricular ejection fraction \<35% or cardiogenic shock
• The ICD implanted/CRT
• Severe bleeding or stroke within 6 months
• Have a history of allergy to iodine contrast agents or any known allergy to clopidogrel, ticagrelor, aspirin, or heparin
• Subjects have been diagnosed or suspected of liver disease, including laboratory evidence of hepatitis
• Valvular heart disease significantly affecting hemodynamics, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
• 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
• 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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

China · 1 center

• General Hospital of Shenyang Military Region — Beijing

Identifiers

NCT: NCT04944615

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗