Near-infrared spectroscopy and intravascular ultrasound for risk stratification of coronary stenosis with deferred revascularization based on fractional flow reserve: The STRATIFY-NIRS study

Near-infrared spectroscopy and intravascular ultrasound for risk stratification of coronary stenosis with deferred revascularization based on fractional flow reserve: The STRATIFY-NIRS study - STRATIFY-NIRS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048311

Enrollment

400

Registered

2022-07-11

Start date

2022-07-06

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Acute coronary syndrome

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients >=18 years of age. 2. Patients with ACS undergoing PCI within 4 weeks before study enrollment. 3. Patients with deferred coronary lesions by FFR (i.e. FFR>0.80) with a moderate stenosis (visual estimation of diameter stenosis >=50%, <90% by coronary angiography) in non-culprit coronary artery.

Exclusion criteria

Exclusion criteria: 1. Target vessels* previously treated by PCI. 2. Target vessels* with significant coronary calcification or tortuosity deemed to preclude NIRS-IVUS evaluation. 3. Target vessels* with reference lumen diameter <=2mm. 4. History of CABG. 5. Unstable clinical status (hemodynamic or electrical instability). 6. Patients unwilling or unable to provide informed consent. 7. Life expectancy is less than 1 year at study enrollment. 8. Patients considered unsuitable for the study at the discretion of the operator. *Target vessel is defined as a non-culprit coronary artery with deferred coronary lesions by FFR (i.e. FFR>0.80) with a moderate stenosis (visual estimation of diameter stenosis >=50%, <90% by coronary angiography).

Design outcomes

Primary

Measure	Time frame
Target vessel failure (cardiac death, target-vessel myocardial infarction, clinically-driven target vessel revascularization) at 2 years	—

Secondary

Measure	Time frame
TVF at 1, 3, 4, 5 years Death at 1, 2, 3, 4, 5 years Cardiac death at 1, 2, 3, 4, 5 years Non-cardiac death at 1, 2, 3, 4, 5 years MI at 1, 2, 3, 4, 5 years Target-vessel MI at 1, 2, 3, 4, 5 years Revascularization at 1, 2, 3, 4, 5 years Clinically-driven revascularization at 1, 2, 3, 4, 5 years Target vessel revascularization at 1, 2, 3, 4, 5 years Clinically-driven target vessel revascularization at 1, 2, 3, 4, 5 years Target lesion revascularization at 1, 2, 3, 4, 5 years Clinically-driven target lesion revascularization at 1, 2, 3, 4, 5 years Stroke at 1, 2, 3, 4, 5 years Bleeding at 1, 2, 3, 4, 5 years Secondary imaging outcome measures: Correlation among FFR value, plaque burden by IVUS, MLA by IVUS, and LCBI. Correlation among plaque burden by IVUS, MLA by IVUS, and LCBI by NIRS-IVUS, plaque burden by CT, plaque type by CT, and diameter stenosis by CT. Correlation among PPG (pullback pressure gradient), plaque burden by IVUS, MLA by IVUS, and LCBI. Sub-group analysis: MaxLCBI4mm 400 MaxLCBI4mm median value Plaque burden >=70% Minimal lumen area <=4.0 mm2 Hemodialysis PCI indication (STEMI vs. NSTEMI vs. UAP) Ischemic risk Diabetes Sub categories of FFR value (FFR0.81-0.85, 0.86-0.90, 0.91-1.00) Diameter stenosis, CT value <30 HU, positive remodeling, spotty calcification, napkin ring sign as assessed by coronary CT	—

Measure

Time frame

TVF at 1, 3, 4, 5 years Death at 1, 2, 3, 4, 5 years Cardiac death at 1, 2, 3, 4, 5 years Non-cardiac death at 1, 2, 3, 4, 5 years MI at 1, 2, 3, 4, 5 years Target-vessel MI at 1, 2, 3, 4, 5 years Revascularization at 1, 2, 3, 4, 5 years Clinically-driven revascularization at 1, 2, 3, 4, 5 years Target vessel revascularization at 1, 2, 3, 4, 5 years Clinically-driven target vessel revascularization at 1, 2, 3, 4, 5 years Target lesion revascularization at 1, 2, 3, 4, 5 years Clinically-driven target lesion revascularization at 1, 2, 3, 4, 5 years Stroke at 1, 2, 3, 4, 5 years Bleeding at 1, 2, 3, 4, 5 years Secondary imaging outcome measures: Correlation among FFR value, plaque burden by IVUS, MLA by IVUS, and LCBI. Correlation among plaque burden by IVUS, MLA by IVUS, and LCBI by NIRS-IVUS, plaque burden by CT, plaque type by CT, and diameter stenosis by CT. Correlation among PPG (pullback pressure gradient), plaque burden by IVUS, MLA by IVUS, and LCBI. Sub-group analysis: MaxLCBI4mm 400 MaxLCBI4mm median value Plaque burden >=70% Minimal lumen area <=4.0 mm2 Hemodialysis PCI indication (STEMI vs. NSTEMI vs. UAP) Ischemic risk Diabetes Sub categories of FFR value (FFR0.81-0.85, 0.86-0.90, 0.91-1.00) Diameter stenosis, CT value <30 HU, positive remodeling, spotty calcification, napkin ring sign as assessed by coronary CT

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Countries

Japan

Contacts

Public ContactYasushi Ueki

Shinshu University Hospital Cardiovascular Medicine

yasushi522@shinshu-u.ac.jp0263-37-3352

Outcome results