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

NCT04397211 | Active Not Recruiting DMC

• 1 other identifier: 2019-303
• Study Type: interventional
• Target: 1,872
• Locations: 2 countries
• Sites: 23

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

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

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 12 months after randomization according to the ARC definitions.

  12 months

Secondary Outcomes (12)

• Patient-oriented composite outcome (POCO)

  24, 60 months

• Target vessel failure

  12, 24 and 60 months

• Cost-effectiveness analysis

  12, 24 and 60 months

• All-cause and cardiac death

  12, 24 and 60 months

• Any nonfatal MI without peri-procedural MI

  12, 24 and 60 months

Study Arms (2)

Angiography-derived FFR-guided PCI group

ACTIVE COMPARATOR

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

Procedure: Angiography-derived FFR

IVUS-guided PCI group

ACTIVE COMPARATOR

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

Procedure: IVUS

Interventions

Angiography-derived FFR 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

Angiography-derived FFR-guided PCI group

IVUS 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%

IVUS-guided PCI group

Eligibility Criteria

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

You may qualify if:

• 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 \[RCA\])

You may not qualify if:

• 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)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Seoul National University Hospital: collaborator
• Affiliated Hangzhou First People's Hospital: collaborator
• Wuhan University: collaborator
• Peking University Third Hospital: collaborator
• The Affiliated Hospital of Hangzhou Normal University: collaborator
• RenJi Hospital: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Changxing People's Hospital: collaborator
• The Affiliated Hospital of Medical College, Ningbo University: collaborator
• Jinhua Central Hospital: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator
• Dongyang People's Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Jining First People's Hospital: collaborator
• Second Affiliated Hospital of Shantou University Medical College: collaborator
• Ulsan University Hospital: collaborator
• Huizhou Municipal Central Hospital: collaborator
• Zhejiang Greentown Cardiovascular Hospital: collaborator
• The Fourth People's Hospital of Jinan: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator

Study Sites (23)

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

Hangzhou, Zhejiang, China

Location

Peking University Third Hospital

Beijing, China

Location

Second Affiliated Hospital of Shantou University Medical College

Guangdong, China

Location

Affiliated Hangzhou First People's Hospital

Hangzhou, China

Location

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, China

Location

Zhejiang Greentown Cardiovascular Hospital

Hangzhou, China

Location

Changxing People's Hospital

Huzhou, China

Location

Huzhou Central Hospital

Huzhou, China

Location

The Fourth People's Hospital of Jinan

Jinan, China

Location

Dongyang People's Hospital

Jinhua, China

Location

Jinhua Central Hospital

Jinhua, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

The Affiliated Hospital of Medical College, Ningbo University

Ningbo, China

Location

Shandong Jining No.1 People's Hospital

Shandong, China

Location

Shandong University of Traditional Chinese Medicine

Shandong, China

Location

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Second hospital of Shanxi Medical University

Taiyuan, China

Location

The first affiliated hospital of Wenzhou Medical University

Wenzhou, China

Location

The second affiliated hospital of Wenzhou Medical University

Wenzhou, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, China

Location

Seoul National University Hospital,

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

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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

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: May 17, 2020
• First Posted: May 21, 2020
• Study Start: May 29, 2020
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 23, 2024

Record last verified: 2024-01

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 (21); KR (2)