A Prospective, Multicenter, Blinded, Randomized, Noninferiority Clinical Trial of Coronary Angiography Fractional Flow Reserve (caFFR) Versus Fractional Flow Reserve (FFR) to Guide Percutaneous Coronary Intervention(Flash FFR Ⅱ )

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The overall purpose of Flash FFR Ⅱ is to investigate whether coronary angiography-derived fractional flow reserve (caFFR), compared with fractional flow reserve (FFR) measured by a pressure wire, has non-inferior clinical effect and cost benefit in guiding the percutaneous coronary intervention (PCI) for patients with moderate coronary artery stenosis in terms of long-term clinical prognosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• General inclusion criteria:

∙ Age above 18 years old, no limit on the gender;

‣ Angiography is considered necessary and feasible by investigator, and PCI will be performed if necessary;

‣ Suspected coronary heart disease, stable angina pectoris, unstable angina pectoris, non-culprit vascular assessment in participants with acute non-ST-segment elevation myocardial infarction, and non-culprit vascular assessment in patients with previous ST-segment elevation acute myocardial infarction;

‣ Participants voluntarily participate in this clinical trial and sign informed consent form.

• Coronary angiography inclusion criteria:

• The presence of at least one stenosis and meets the following imaging findings:

⁃ The degree of coronary artery stenosis≥50% and ≤90% by visual measurement;

⁃ The reference diameter of the stenotic segment≥2.25 mm by visual measurement;

⁃ The investigator visually observes the target vessel through angiographic images, and consider that PCI surgery is technically feasible.

Locations
Other Locations
China
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
RECRUITING
Beijing
Department of Cardiology, Peking University First Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
West China Hospital, Sichuan University
RECRUITING
Chengdu
Guangdong Provincial People's Hospital
COMPLETED
Guangzhou
The People's Hospital of Hebi
RECRUITING
Hebi
QILU Hospital of Shandong University
RECRUITING
Jinan
Affiliated Hospital of Yunnan University
RECRUITING
Kunming
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Zhongshan Hospital affiliated to Fudan University
RECRUITING
Shanghai
The University of Hong Kong Shenzhen hospital
RECRUITING
Shenzhen
Xiamen Cardiovascular Hospital Xiamen University
RECRUITING
Xiamen
The First Affiliated Hospital of Xinxiang Medical College
RECRUITING
Xinxiang
Contact Information
Primary
Yanjun Gong, MD
gongyanjun111@163.com
8610-83575607
Time Frame
Start Date: 2021-01-12
Estimated Completion Date: 2025-12
Participants
Target number of participants: 2132
Treatments
Experimental: caFFR-guided
Participants who are randomly assigned to caFFR-guided group will receive the detection of Coronary Angiography-Derived Fractional Flow Reserve (caFFR) Measurement System. The online caFFR value is used to guide the PCI strategy. If caFFR ≤ 0.80, PCI treatment will be performed in lesions and optimal medicine treatment will be performed when caFFR \> 0.80.
Active_comparator: FFR-guided
Participants who are randomly assigned to FFR-guided group will receive the detection of pressure wire. The FFR value is used to guide the PCI strategy. If FFR ≤ 0.80, PCI treatment will be performed in lesions and optimal medicine treatment will be performed when FFR \> 0.80.
Sponsors
Collaborators: Rainmed Ltd., Suzhou, China
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov