Status:
RECRUITING
FFR Versus IVUS with Angiography-Derived FFR for Clinical Outcomes in Patients with Coronary Artery Disease
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Seoul National University Hospital
Peking University Third Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
To compare the clinical outcomes of fractional flow reserve (FFR)-guided strategy versus intravascular ultrasound (IVUS)-guided stent implantation after angiography-derived FFR-based decision-making.
Detailed Description
1. Hypothesis: The IVUS-guided stent implantation after angiography-derived FFR-based decision-making will show superiority in terms of a lower rate of patients-oriented composite outcomes (POCO) at 2...
Eligibility Criteria
Inclusion
- Subject must be ≥ 19 years.
- Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent.
- Subjects suspected with ischemic heart disease.
- Subjects with coronary artery diameter stenosis 50-90% by angiography-based visual estimation eligible for stent implantation.
- Target vessel size ≥ 2.5mm in visual estimation.
Exclusion
- Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor
- Active pathologic bleeding.
- Gastrointestinal or genitourinary major bleeding within the prior 3 months.
- History of bleeding diathesis, known coagulopathy.
- Non-cardiac co-morbid conditions with life expectancy \< 2 years.
- Target lesion located in coronary arterial bypass graft.
- Left main coronary artery stenosis ≥ 50%.
- Chronic total occlusion in the study target vessel.
- Culprit lesion of ST-elevation myocardial infarction (STEMI).
- Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, severe tortuosity, severe overlap, poor image quality).
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
1942 Patients enrolled
Trial Details
Trial ID
NCT06218485
Start Date
March 13 2024
End Date
December 1 2029
Last Update
February 24 2025
Active Locations (25)
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1
Peking University Third Hospital
Beijing, China
2
Second Affiliated Hospital of Shantou University Medical College
Guangdong, China
3
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
4
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China