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FFR Versus IVUS with Angiography-Derived FFR for Clinical Outcomes in Patients with Coronary Artery Disease

RECRUITINGN/ASponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University
Actively Recruiting
PhaseN/A
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Started2024-03-13
Est. completion2027-12-01
Eligibility
Age19 Years+
Healthy vol.Accepted

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.

Eligibility

Age: 19 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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).

Conditions2

Coronary Artery DiseaseHeart Disease

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