A Prospective Multicenter Real-World Registry of Quantitative Flow Ratio-Guided Coronary REvascularization and QuAlity evaLuation

NCT07766434 | Not Yet Recruiting

• 1 other identifier: 2025ZD0546701
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multicenter observational registry aims to establish a QFR-based quality control standard system for coronary revascularization in patients with coronary artery disease. The study will enroll over 10,000 patients with visually estimated at least one main branch coronary stenosis ≥50% from more than 50 centers across China (covering provincial, municipal, and county-level hospitals). Coronary angiographic images and intracoronary imaging (if available) will be collected and retrospectively analyzed by an independent core laboratory. The primary endpoint is QFR acquisition accessibility, defined as the mean of QFR usage proportion across centers.

Conditions

Coronary Artery Disease

Keywords

Quantitative Coronary Angiography; Quantitative Flow Ratio; Percutaneous Coronary Intervention; Myocardial Ischaemia

Outcome Measures

Primary Outcomes (1)

• QFR Adoption Rate

  Defined as the mean across participating centers of the proportion of patients undergoing QFR assessment among eligible patients at each center.

  At enrollment (baseline)

Secondary Outcomes (6)

• MACE

  6 month, 1 year, 3 years, and 5 years

• Death

  6 months, 1 year, 3 years, and 5 years

• MI

  6 months, 1 year, 3 years, and 5 years

• Target vessel revascularization (TVR)

  6 months, 1 year, 3 years, and 5 years

• Any coronary artery revascularization

  6 months, 1 year, 3 years, and 5 years

Eligibility Criteria

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

Study Population

Patients with coronary angiography showing visually estimated at least one main branch coronary stenosis ≥50% who present with asymptomatic ischemia, stable angina, unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction (\>4 weeks after onset) and undergo PCI or receive conservative treatment at one of the participating centers.

You may qualify if:

• Age ≥18 years
• Coronary angiography showing visually estimated at least one main branch coronary stenosis ≥50% in patients with acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction \>4 weeks after onset) or chronic coronary syndrome (including stable angina and asymptomatic myocardial ischemia) who undergo PCI or receive conservative treatment
• Ability to understand the study design and provide written informed consent

You may not qualify if:

• ST-segment elevation myocardial infarction within 4 weeks of onset
• History of coronary artery bypass grafting (CABG) or planned CABG within 6 months
• Inability to undergo coronary angiography
• Non-cardiac cause with expected survival \<1 year
• Other conditions that may interfere with follow-up (e.g., dementia, substance abuse including drug addiction and other drug dependencies)
• Refusal to participate in the study

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Guangdong Provincial People's Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Fuwai Huazhong Cardiovascular Hospital: collaborator
• Fuwai Yunnan Cardiovascular Hospital: collaborator
• Second Hospital of Jilin University: collaborator

Study Sites (1)

National Clinical Research Center of Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (4)

• Zhang R, Wang HY, Song L, Guan C, Yin D, Zhu C, Feng L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Zhao Y, Wang Y, Liu W, Qiao S, Tu S, Wijns W, Dou K; FAVOR III China Study Group. Rationales Behind Physiology-Guided Revascularization: Diagnostic Impact of Quantitative Flow Ratio in the FAVOR III China Trial. JACC Cardiovasc Interv. 2026 Feb 23;19(4):422-434. doi: 10.1016/j.jcin.2025.10.042. Epub 2025 Nov 20.

  PMID: 41263729 BACKGROUND

• Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.

  PMID: 39210710 BACKGROUND

• Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.

  PMID: 34742368 BACKGROUND

• Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.

  PMID: 29101020 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jie Qian, PhD

CONTACT

010-88396089; qianjfw@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-04

Locations

CN (1)