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Clinical Trials in China / NCT04944615
Recruiting Not applicable

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.

NCT04944615 · tracked via the Priya Life Science China tracker
Sponsor
CCRF Inc., Beijing, China
Phase
Not applicable
Started
2022-10-21
Last updated
2023-03-29

Condition(s) studied

Chronic Total Occlusion of Coronary Artery

Investigational drug(s) / intervention(s)

The guidewire successfully passed the CTO lesion

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
General Hospital of Shenyang Military Region Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04944615 on ClinicalTrials.gov ↗ ← All trials in China