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NCT04944615Active, not recruiting

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.

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
1448 (estimated)
First submitted
1 Jun 2021
Start date
21 Oct 2022
Primary completion date
Oct 2031
Lead sponsor
CCRF Inc., Beijing, China
NCT number
NCT04944615

What you commit to

  • Study type: Interventional
  • Planned participants: 1448
  • From 21 Oct 2022 to the primary completion date, Oct 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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
    • Clinical 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

Criteria the registry did not label

  • Clinical 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
General Hospital of Shenyang Military Region
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.