Angiography-Derived FFR And IVUS for Clinical Outcomes in Patients With Coronary Artery Disease
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- STATUS
- Recruiting
-
- End date
- May 5, 2027
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- participants needed
- 1872
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- sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
Comparison of Angiography-derived Fractional FLow Reserve And IntraVascular Ultrasound-guided
Intervention Strategy for Clinical OUtcomes in Patients with CoRonary
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
- Primary endpoint: patient-oriented composite outcome (a composite of all-cause death,
MI , any revascularization) at 12 months afterPCI - 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 anattrition rate.
3.Research Materials and Indication for Revascularization For the angiography-derived
FFR-guided strategy
Details
| Condition |
Coronary |
|---|---|
| Age | 18years - 100years |
| Treatment |
Angiography-derived FFR,
|
| Clinical Study Identifier | NCT04397211 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Last Modified on | 19 February 2024 |
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