NCT05648396

Brief Summary

This study aims to collect data on clinical outcomes of real world patients undergoing FFRangio guided treatment for coronary artery disease in Japan and Israel through a retrospective multicentre registry.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Nov 2022Dec 2027

Study Start

First participant enrolled

November 7, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

2.2 years

First QC Date

November 12, 2022

Last Update Submit

December 4, 2022

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • composite of Cardio-Vascular(CV) mortality/Myocardial infarction (MI)/Repeat revascularization

    Composite of CV mortality/MI/Repeat revascularization

    1 year

Secondary Outcomes (9)

  • Overall death

    1 year

  • Cardio Vascular death

    1 year

  • MyocardiaI infarction (MI)

    1 year

  • Repeat revascularization

    1 year

  • Urgent repeat revascularization

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Revascularization

Patients undergoing angiogram in which FFRangio is used to assess the physiologic significance of at least one coronary lesion, and based on this assessment are referred for coronary revascularization (PCI/CABG).

Other: FFRangio

Deferral

Patients undergoing angiogram in which FFRangio is used to assess the physiologic significance of at least one coronary lesion, and based on this assessment are assigned to conservative management (optimal guidelines directed medical treatment).

Other: FFRangio

Interventions

FFRangioOTHER

Assessing the physiologic significance of an intermediate coronary lesion/lesions using FFRangio - a non invasive method to calculate the fractional flow reserve (FFR) of the assessed lesion.

DeferralRevascularization

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all comers patients undergoing coronary angiogram, in which FFRangio is used to assess the physiologic significance of at least one coronary lesion.

You may qualify if:

  • Patients undergoing coronary angiogram for a clinical indication, for whom FFRangio is used to assess the physiologic significance of at least 1 coronary lesion and guide the treatment decisions.

You may not qualify if:

  • Culprit lesion of a STEMI (patients undergoing PCI for non-culprit lesions can be included if the culprit lesion has been successfully treated prior to the non-culprit PCI
  • Presence of significant (moderate+) valvular heart disease
  • Chronic total occlusion in one of the coronary arteries
  • Isolated significant left main disease
  • Prior coronary artery bypass graft surgery
  • Clinical presentation of cardiogenic shock or severe LV dysfunction
  • Coronary anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Centre

Petah Tikva, 4941492, Israel

Location

Related Publications (2)

  • Witberg G, Kikuta Y, Dan K, Matsumura M, Maehara A, Tanigaki T, Yokoi H, Hikichi Y, Nanasato M, Miura K, Sato K, Taniguchi M, Goto K, Haruta S, Levi A, Otake H, Fearon WF, Matsuo H, Kornowski R, Takebayashi H. Mid-term clinical outcomes of FFRangio guided treatment for coronary artery disease: Insights from an international multicentre registry. Cardiovasc Revasc Med. 2026 Jan 23:S1553-8389(26)00013-8. doi: 10.1016/j.carrev.2026.01.012. Online ahead of print.

    PMID: 41620337DERIVED

  • Dan K, Witberg G, Itabashi F, Maeda T, Kikuta Y, Okabe K, Tanigaki T, Nanasato M, Hikichi Y, Yokoi H, Kornowski R, Matsuo H. Comparison of angiogram-based physiological assessment system sizing tool and intravascular ultrasound imaging measurements. Cardiovasc Revasc Med. 2025 Sep;78:80-85. doi: 10.1016/j.carrev.2025.03.012. Epub 2025 Mar 18.

    PMID: 40148172DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Guy Witberg, MD, MPH

    Rabin Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant inteventional cardiologist

Study Record Dates

First Submitted

November 12, 2022

First Posted

December 13, 2022

Study Start

November 7, 2022

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)