Evaluating IVUS-guided drug-eluting stents for chronic total occlusion treatment
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
This study is testing whether using ultrasound to guide heart stent placement helps people with blocked coronary arteries feel better in the long run compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1448 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CCRF Inc., Beijing, China Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04944615 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intravascular ultrasonography (IVUS) in guiding the implantation of drug-eluting stents (DES) for patients with chronic total occlusion (CTO) of coronary arteries. It is a prospective, multicenter, open-label, randomized controlled trial involving 1448 patients who have undergone successful guide wire passage through the CTO lesion. Participants will be randomly assigned to receive either IVUS-guided or conventional angiography-guided stent implantation, with the aim of determining which method leads to better long-term clinical outcomes. The study will take place across up to 45 research centers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with ischemic heart disease symptoms and a primary coronary artery CTO lesion suitable for percutaneous coronary intervention.
Not a fit: Patients who are pregnant, lactating, or have severe coronary artery disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved clinical outcomes for patients with chronic total occlusion of coronary arteries.
How similar studies have performed: Previous studies have shown promising results with IVUS-guided interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing
- General Hospital of Shenyang Military Region — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.