Clinical trial NCT04944615: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Total Occlusion of Coronary Artery
Keywords: TIMI flow = grade 0 coronary artery disease with a duration greater than 3 months.
Lead sponsor: CCRF Inc., Beijing, China
Sponsor class: INDUSTRY
Collaborators: name: BSC International Medical Trading (Shanghai) Co., Ltd.
First posted: 2021-06-29
Enrollment: 1448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were enrolled when the guide wire successfully passed through the CTO lesion (defined as: the guide wire successfully passed through the CTO lesion and reached the distal true lumen as confirmed by angiography).

Once patients have signed the informed consent form and met all clinical and angiographic inclusion criteria and did not meet all clinical and angiographic exclusion criteria, and the guide wire has successfully passed the CTO lesion, they may be considered for participation in the study and randomized.

The random grouping arrangement is computer generated using a quasi-random number generator.

All randomized subjects will be assigned a unique identification number. Randomized replacement blocks will be used to ensure that the distribution of treatment within each layer is approximately balanced.

The study also used the Interactive Voice Response System (IVRS)/Interactive Internet Response System (IWRS) to assign subjects to the study device treatment group.
Primary purpose: OTHER

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.

Eligibility criteria: 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 \&lt;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

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 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 outcomes:
measure: Cardiogenic death
timeFrame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
measure: Nonfatal myocardial infarction
timeFrame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
measure: Target lesion revascularization
timeFrame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
measure: Target vessel revascularization
timeFrame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
measure: Target lesion failure
timeFrame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
measure: Target vessel failure
timeFrame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
measure: Left ventricular function improved
timeFrame: Baseline period and one-year follow-up period
measure: Percentage stenosis of segmental and stent diameter
timeFrame: The follow-up period was 12 months
measure: Lumens in segmental vessels and stents were lost
timeFrame: The follow-up period was 12 months
measure: Binary restenosis rate in segment and stent
timeFrame: The follow-up period was 12 months
measure: Minimum lumen diameters in segments and stents
timeFrame: The follow-up period was 12 months
measure: QCA measurements were obtained immediately in the lumen
timeFrame: Baseline operative period
measure: MLD measured by QCA
timeFrame: Baseline operative period
measure: Clinical success rate
timeFrame: Baseline operative period
Other outcomes:
Locations:
city: Beijing
country: China
facility: General Hospital of Shenyang Military Region
Study officials:
References: