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.

Launched by CCRF INC., BEIJING, CHINA · Jun 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat a heart condition called Chronic Total Occlusion (CTO), which occurs when a coronary artery is completely blocked. The research is comparing two methods: one that uses advanced imaging technology called Intravascular Ultrasonography (IVUS) to guide the placement of a special type of stent (a small tube that helps keep blood vessels open), and the traditional method that relies on standard imaging techniques. The goal is to see if the IVUS-guided approach leads to better long-term health outcomes for patients.

To participate in this trial, individuals need to be at least 18 years old and have symptoms related to ischemic heart disease, which means their heart isn't getting enough blood. They should be scheduled for a procedure to open their blocked artery and must be willing to follow the study's treatment and follow-up plans. However, certain conditions might exclude someone from joining, such as severe heart disease, recent heart attacks, or specific allergies. Participants can expect to undergo a procedure with careful monitoring, and they will help researchers learn whether this new technique is more effective than the standard method.

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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 \<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