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Compares treatment options for Chronic Total Occlusion of Coronary Artery
Official title 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.
ClinicalTrials.gov ID: NCT04944615
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical
- At least 18 years old
- people will understand the test requirements, treatment and surgery, and can provide written informed consent
- people with clinical symptoms of ischemic heart disease or evidence of myocardial ischemia associated with CTO target vessels and scheduled to...
- people will receive percutaneous coronary intervention
You likely can't join if
- 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
See the full eligibility criteria
- Clinical
- At least 18 years old
- people will understand the test requirements, treatment and surgery, and can provide written informed consent
- people 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)
- people will receive percutaneous coronary intervention
- people are willing to accept all treatment and follow-up evaluations required by the protocol for angiography:
- 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
- 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
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.