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

NCT06218485 | Recruiting DMC

• 1 other identifier: 2023-0896
• Study Type: interventional
• Target: 1,942
• Locations: 2 countries
• Sites: 25

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.

Conditions

Coronary Artery Disease

Keywords

Angiography-derived fractional flow reserve; Intravascular ultrasound; Fractional flow reserve; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Patient-oriented composite outcome

  Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI), or any revascularization at 24 months after randomization.

  24 months

Secondary Outcomes (12)

• Patient-oriented composite outcome at 60 months

  60 months

• Individual component of Patient-oriented composite outcome

  24 and 60 months

• Target vessel failure

  24 and 60 months

• Cost-effectiveness analysis

  24 and 60 months

• All-cause and cardiac death

  24 and 60 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making.

Procedure: Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making

Control group

ACTIVE COMPARATOR

The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy.

Procedure: Fractional flow reserve-guided PCI strategy

Interventions

Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making PROCEDURE

The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making: 1. PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR \>0.80. 2. If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area

Experimental group

Fractional flow reserve-guided PCI strategy PROCEDURE

The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy: 1. PCI will be performed if FFR ≤0.80 and will be deferred if FFR \>0.80. 2. If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR (\[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Seoul National University Hospital: collaborator
• Peking University Third Hospital: collaborator
• RenJi Hospital: collaborator
• Second Affiliated Hospital of Shantou University Medical College: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• The Fourth People's Hospital of Jinan: collaborator
• Jinhua Central Hospital: collaborator
• The Affiliated Hospital of Hangzhou Normal University: collaborator
• Changxing People's Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• The Affiliated Hospital of Medical College, Ningbo University: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Inje University Ilsan Paik Hospital: collaborator
• Ulsan University Hospital: collaborator
• Uijeongbu Eulji Medical Center: collaborator
• Kyungpook National University Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator
• Yonsei University Wonju Severance Hospital: collaborator
• Inje University Haeundae Paik Hospital: collaborator
• Sejong General Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• The Affiliated Hospital of Shandong University of TCM: collaborator

Study Sites (25)

Peking University Third Hospital

Beijing, China

RECRUITING

Second Affiliated Hospital of Shantou University Medical College

Guangdong, China

RECRUITING

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

NOT YET RECRUITING

Changxing People's Hospital

Huzhou, China

RECRUITING

The Affiliated Hospital of Shandong University of TCM

Jinan, China

NOT YET RECRUITING

The Fourth People's Hospital of Jinan

Jinan, China

RECRUITING

Jinhua Central Hospital

Jinhua, China

RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, China

NOT YET RECRUITING

The Affiliated Hospital of Medical College, Ningbo University

Ningbo, China

RECRUITING

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

NOT YET RECRUITING

The First Affiliated hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

Bucheon Sejong Hospital

Bucheon-si, South Korea

NOT YET RECRUITING

Inje University Haeundae Paik Hospital

Busan, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

NOT YET RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

NOT YET RECRUITING

Chonnam National University Hospital

Donggu, South Korea

NOT YET RECRUITING

Inje University Ilsan Paik Hospital

Goyang, South Korea

NOT YET RECRUITING

Seoul National University Hospital,

Seoul, South Korea

RECRUITING

Seoul ST. Mary's Hospital

Seoul, South Korea

NOT YET RECRUITING

Uijeongbu Eulji Medical Center

Uijeongbu-si, South Korea

NOT YET RECRUITING

Ulsan University Hospital

Ulsan, South Korea

NOT YET RECRUITING

Yonsei University Wonju Severance Hospital

Wŏnju, South Korea

NOT YET RECRUITING

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jian'an Wang, MD, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyang Hu, MD, PhD

CONTACT

+86 0571 87784808; hxy0507@126.com

Jinlong Zhang, MD, PhD

CONTACT

+86 15757197513; jinlong1102@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 23, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 24, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement

Locations

CN (14); KR (11)