Angiography-Derived FFR And IVUS for Clinical Outcomes in Patients With Coronary Artery Disease

  • STATUS
    Recruiting
  • End date
    May 24, 2027
  • participants needed
    1872
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 24 January 2021
angiography
stenosis
heart disease
percutaneous coronary intervention
intravascular ultrasound
arterial disease
revascularisation

Summary

Comparison of Angiography-derived Fractional FLow Reserve And IntraVascular Ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with CoRonary Artery Disease

Description

The primary hypothesis is that angiography-derived FFR-guided strategy will show non-inferior rate of patients-oriented composite outcomes (POCO) at 12 months after randomization, compared with IVUS-guided strategy in patients with CAD.

2. Study population and sample size calculation Sample size calculation based on the event rates of previous trials, investigators predicted the rates of POCO at 12 months after PCI will be 7% in the Angiography-derived FFR-guided arm, and 8% in the IVUS-guided arm

  • Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any revascularization) at 12 months after PCI
  • Design: non-inferiority, delta = 2.5%
  • Sampling ratio: angiography-derived FFR-guided strategy: IVUS-guided strategy = 1:1
  • Type I error (): One-sided 2.5%
  • Accrual time: 2 years
  • Total time: 3 years (accrual 2 years + follow-up 1 years)
  • Assumption: POCO 7.0% vs. 8.0% in angiography-derived FFR or IVUS-guided strategy, respectively
  • Statistical power (1- ): 80%
  • Primary statistical method: Kaplan-Meier survival analysis with log-rank test
  • Estimated attrition rate: total 5%
  • Stratification in Randomization: Presence of diabetes mellitus (35% of patients in each group) Based on the above assumption, we would need total 1,872 patients (936 patients in each group) with consideration of an attrition rate.

3.Research Materials and Indication for Revascularization For the angiography-derived FFR-guided strategy arm, Criteria for revascularization: angiography-derived FFR 0.80. For the IVUS-guided strategy arm, the criterion for revascularization is MLA 3mm2 or [3mm2 < MLA 4mm2 and plaque burden > 70%].

Details
Condition Coronary Artery Disease, Coronary Artery Disease, Coronary heart disease, Cardiac Ischemia, Myocardial Ischemia
Treatment IVUS, Angiography-derived FFR
Clinical Study IdentifierNCT04397211
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must be 18 years. Subject is able to verbally confirm understandings 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 prior to any study related procedure. Patients suspected with ischemic heart disease. Patients with 50 stenosis by angiography-based visual estimation eligible for stent implantation. Target vessel size 2.5mm in visual estimation. Target vessels are limited to major epicardial coronary arteries (left anterior descending artery[LAD], left circumflex artery [LCX], right coronary artery [RCA])

Exclusion Criteria

The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled.) Patients with active pathologic bleeding. Gastrointestinal or genitourinary major bleeding within the prior 3 months. History of bleeding. diathesis, known coagulopathy (including heparin-induced thrombocytopenia). Non-cardiac co-morbid conditions with life expectancy < 1 year. Target vessel total occlusion. Target lesion located in coronary arterial bypass graft. Left main coronary artery stenosis 50%. Not eligible for angiography-derived FFR (ostial RCA 50% stenosis, myocardial bridging, severe tortuosity, severe overlap, poor image quality)
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