FFR guided PCI optimization directed by high-definition IVUS versus standard of care: the randomized FFR-REACT trial

FFR guided PCI optimization directed by high-definition IVUS versus standard of care: the randomized FFR-REACT trial - FFR-REACT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50576

Enrollment

640

Registered

2017-10-26

Start date

2017-10-31

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery narrowing coronary artery stenosis

Interventions

FFR-guided optimization directed by the ACIST HDi® IVUS System using the Kodama® IVUS catheter will be performed in the treatment arm. Patients will be followed for up to 3 years.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 2. Stable- or unstable angina or Non-ST segment elevation myocardial infarction 3. Target lesion stenosis >= 50% by visual estimation or QCA

Exclusion criteria

Exclusion criteria: 1. Patients with ST-elevation myocardial infarction (STEMI) or evidence of myocardial infarction within 72 hours before the index procedure 2. Target vessel distal reference diameter

Design outcomes

Primary

Measure	Time frame
Target vessel failure (TVF), a composite of cardiac death, target-vessel myocardial infarction and clinically driven TVR at 1 year.	—

Secondary

Measure	Time frame
Secondary safety endpoint (at 6 months, 1, 2 and 3 years follow-up) (Definitions Appendix IV) The individual components of the primary endpoint (cardiac death, target vessel MI, clinically driven target vessel revascularization) All-cause death Target lesion revascularization Target vessel revascularization Any coronary revascularization Non-fatal myocardial infarction Stent thrombosis (according the ARC criteria) Peri-procedural MI Change in post-procedural Pd/Pa and FFR after optimization therapy Acute kidney injury Stroke Periprocedural complications Correlation outcome of proximal versus stent versus distal FFR drop in categories of 5% pressure drop. Correlation of FFR segmental drop and minimum luminal area (MLA ) on IVUS and 3D QCA Correlation of Pd/Pa and FFR, both dependent and independent of IVUS findings Correlation of Pd/Pa and FFR and clinical endpoints Operators PCI strategy change dependent on the information received from either FFR or IVUS	—

Measure

Time frame

Secondary safety endpoint (at 6 months, 1, 2 and 3 years follow-up) (Definitions Appendix IV) The individual components of the primary endpoint (cardiac death, target vessel MI, clinically driven target vessel revascularization) All-cause death Target lesion revascularization Target vessel revascularization Any coronary revascularization Non-fatal myocardial infarction Stent thrombosis (according the ARC criteria) Peri-procedural MI Change in post-procedural Pd/Pa and FFR after optimization therapy Acute kidney injury Stroke Periprocedural complications Correlation outcome of proximal versus stent versus distal FFR drop in categories of 5% pressure drop. Correlation of FFR segmental drop and minimum luminal area (MLA ) on IVUS and 3D QCA Correlation of Pd/Pa and FFR, both dependent and independent of IVUS findings Correlation of Pd/Pa and FFR and clinical endpoints Operators PCI strategy change dependent on the information received from either FFR or IVUS

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)