Actively Recruiting
IVUS-CTO: Comparing Intravascular Ultrasound Versus Angiographic Guidance for Drug-Eluting Stent Implantation in Chronic Complete Occlusion of Coronary Artery Disease
Led by CCRF Inc., Beijing, China · Updated on 2023-03-29
1448
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
CCRF Inc., Beijing, China
Lead Sponsor
B
BSC International Medical Trading (Shanghai) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the treatment of Chronic Total Occlusion (CTO) disease of the coronary artery. The study compares the long-term clinical outcomes of using Intravascular Ultrasonography (IVUS) guidance for drug-eluting stent (DES) implantation against conventional angiography guidance. This prospective, multicenter, open-label, randomized controlled study aims to determine which method may provide better results for patients with CTO lesions. Participants will be randomly assigned to either IVUS-guided or angiographic-guided DES implantation. In the IVUS group, the CTO lesions will be examined using an IVUS catheter before and after stent placement, with preoperative vasodilation recommended to prevent spasms. In the angiographic group, stent size and length are chosen by the surgeon based on visual estimation, using commercially available drug-eluting stents excluding first-generation types. Repeat angiograms will be performed immediately after the procedure. Participants will undergo percutaneous coronary intervention (PCI) after the guidewire successfully passes the CTO lesion, confirmed by angiography. Researchers will monitor major adverse cardiac events over about three years, with additional evaluations of cardiogenic death, myocardial infarction, revascularization, and left ventricular function up to four years after surgery. Measurements of artery and stent conditions will be collected at baseline and follow-ups for up to one year. The study will involve regular assessments, including angiograms and clinical success rates, to evaluate treatment effects and safety.
CONDITIONS
Brief 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Understand the study requirements and provide written informed consent
- Have clinical symptoms of ischemic heart disease or evidence of myocardial ischemia related to CTO target vessels
- Scheduled to undergo percutaneous coronary intervention (PCI)
- Willing to accept all treatment and follow-up evaluations required by the protocol
- Primary coronary artery CTO lesion with visible collateral circulation
- Estimated time of complete occlusion (TIMI grade 0) 3 months or longer
- Suitable for stent implantation in target lesions sized 2.25 to 4.0 mm
- CTO lesion length greater than 20 mm
You will not qualify if you...
- Pregnant or lactating women
- Severe coronary artery disease not suitable for PCI
- Acute myocardial infarction within the past 7 days
- Long-term contraindications to dual antiplatelet therapy (DAPT) for at least 1 year
- Known renal insufficiency (glomerular filtration rate below 20 mL/min/1.73 m²)
- Left ventricular ejection fraction less than 35% or cardiogenic shock
- Implanted ICD or CRT devices
- Severe bleeding or stroke within past 6 months
- History of allergy to iodine contrast agents or to clopidogrel, ticagrelor, aspirin, or heparin
- Diagnosed or suspected liver disease including hepatitis
- Significant valvular heart disease, hypertrophic or restrictive cardiomyopathy, or congenital heart disease
- Serious diseases likely to harm patients or interfere with results, including cancer or mental illness, or life expectancy less than one year
- Participation in another drug or device clinical trial within 12 months before baseline surgery
- Target lesion located in the left main artery
- No visible collateral circulation in CTO lesions
- Target lesion in venous or arterial bypass graft
- Target vessel occlusion time less than 3 months (TIMI grade 0)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure visit
Participants undergo percutaneous coronary intervention (PCI) where a guide wire is passed through the chronic total occlusion (CTO) lesion, followed by drug-eluting stent implantation guided by either intravascular ultrasound (IVUS) or angiographic guidance.
1 procedure visit (in-person)
Duration - Up to 48 months after treatment
Participants are monitored for clinical outcomes such as major adverse cardiac events and other heart-related measures up to 48 months after the stent implantation.
Scheduled visits at 30 days, 6 months, 12 months, 24 months, 36 months, and 48 months after surgery
Trial Site Locations
Total: 1 location
1
General Hospital of Shenyang Military Region
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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