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)

  • STATUS
    Recruiting
  • End date
    Oct 6, 2031
  • participants needed
    1448
  • sponsor
    CCRF Inc., Beijing, China
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Updated on 6 April 2023
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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

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.

Details
Condition Chronic Total Occlusion of Coronary Artery
Treatment The guidewire successfully passed the CTO lesion
Clinical Study IdentifierNCT04944615
SponsorCCRF Inc., Beijing, China
Last Modified on6 April 2023

Eligibility

 Yes No Not Sure

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

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
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