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

NCT ID: NCT04397211

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1872 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-29
• Study Completion Date: 2028-09-30

Brief Summary

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

Detailed Description

1. The primary hypothesis is that angiography-derived FFR-guided strategy for PCI with a drug-eluting stent (DES) will show non-inferiority in rates of patients-oriented composite outcomes (POCO) at 12 months after randomization, compared with IVUS-guided strategy for PCI with a DES in patients with coronary artery disease.

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 (α): One-sided 2.5%
• Accrual time: 3 years
• Total time: 4 years (accrual 3 years + follow-up 1 years)
• Assumption: POCO 7.0% vs. 8.0% in angiography-derived FFR or IVUS-guided strategy, respectively
• Statistical power (1- β): 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%].

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angiography-derived FFR-guided PCI group

Percutaneous coronary intervention using drug-eluting stent(s) will be performed by Angiography-derived FFR-guided strategy

Group Type: ACTIVE_COMPARATOR

Angiography-derived FFR

Intervention Type: PROCEDURE

The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the Angiography-derived FFR-guided strategy arm

*Criteria for revascularization: Angiography-derived FFR ≤ 0.80

IVUS-guided PCI group

Percutaneous coronary intervention using drug-eluting stent(s) will be performed by IVUS-guided strategy

Group Type: ACTIVE_COMPARATOR

IVUS

Intervention Type: PROCEDURE

The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm

*Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or 3< MLA ≤ 4mm2 & Plaque burden > 70%

Interventions

Angiography-derived FFR

The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the Angiography-derived FFR-guided strategy arm

*Criteria for revascularization: Angiography-derived FFR ≤ 0.80

Intervention Type: PROCEDURE

IVUS

The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm

*Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or 3< MLA ≤ 4mm2 & Plaque burden > 70%

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ① Subject must be ≥ 18 years. ② 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. ③ Patients suspected with ischemic heart disease. ④ Patients with ≥ 50% stenosis by angiography-based visual estimation eligible for stent implantation. ⑤ Target vessel size ≥ 2.5mm in visual estimation. ⑥ Target vessels are limited to major epicardial coronary arteries (left anterior descending artery[LAD], left circumflex artery [LCX], right coronary artery [RCA])

Exclusion Criteria

• ① 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.) ② Patients with active pathologic bleeding. ③ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ④ History of bleeding. diathesis, known coagulopathy (including heparin-induced thrombocytopenia). ⑤Non-cardiac co-morbid conditions with life expectancy < 1 year. ⑥ Target vessel total occlusion. ⑦ Target lesion located in coronary arterial bypass graft. ⑧ Left main coronary artery stenosis ≥ 50%. ⑨ Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, myocardial bridging, severe tortuosity, severe overlap, poor image quality)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Affiliated Hangzhou First People's Hospital

UNKNOWN

Sponsor Role: collaborator

Wuhan University

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Changxing People's Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Medical College, Ningbo University

OTHER

Sponsor Role: collaborator

Jinhua Central Hospital

OTHER

Sponsor Role: collaborator

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Dongyang People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

Jining First People's Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Shantou University Medical College

OTHER

Sponsor Role: collaborator

Ulsan University Hospital

OTHER

Sponsor Role: collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role: collaborator

Zhejiang Greentown Cardiovascular Hospital

OTHER

Sponsor Role: collaborator

The Fourth People's Hospital of Jinan

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian'an Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Bon-Kwon Koo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Peking University Third Hospital

Beijing, , China

Second Affiliated Hospital of Shantou University Medical College

Guangdong, , China

Affiliated Hangzhou First People's Hospital

Hangzhou, , China

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, , China

Zhejiang Greentown Cardiovascular Hospital

Hangzhou, , China

Changxing People's Hospital

Huzhou, , China

Huzhou Central Hospital

Huzhou, , China

The Fourth People's Hospital of Jinan

Jinan, , China

Dongyang People's Hospital

Jinhua, , China

Jinhua Central Hospital

Jinhua, , China

First Affiliated Hospital of Kunming Medical University

Kunming, , China

The First Affiliated Hospital of Nanchang University

Nanchang, , China

The Affiliated Hospital of Medical College, Ningbo University

Ningbo, , China

Shandong Jining No.1 People's Hospital

Shandong, , China

Shandong University of Traditional Chinese Medicine

Shandong, , China

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, , China

Second hospital of Shanxi Medical University

Taiyuan, , China

The first affiliated hospital of Wenzhou Medical University

Wenzhou, , China

The second affiliated hospital of Wenzhou Medical University

Wenzhou, , China

Zhongnan Hospital of Wuhan University

Wuhan, , China

Seoul National University Hospital,

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Countries

China; South Korea

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Other Identifiers

2019-303

Identifier Type: -

Identifier Source: org_study_id