iFR Pressure Wires in Assessment of the Provisional Side-branch Intervention Strategy for Bifurcation Lesions

Nova-Med Medical Research Association

Status

Completed

Conditions

Coronary Bifurcation Lesions

Treatments

Device: iFR pressure-wire

Device: Conventional

Study type

Interventional

Funder types

Other

Identifiers

NCT03027830

Details and patient eligibility

About

Even in the era of drug-eluting stents, bifurcation lesions remain one of the most challenging lesion subsets in coronary intervention practice. This study was performed to evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch intervention strategy.

Full description

Fractional flow reserve (FFR) measurements require minimal and constant microvascular resistance which is routinely achieved by intravenous adenosine infusion. Adenosine-induced hyperemia establishes an optimal vascular environment for FFR measurement. However, breathlessness and chest tightness are common adverse events during adenosine infusion and severe asthma occurs occasionally. The Introduction of an adenosine-independent index (instantaneous wave-free ratio [iFR]) into clinical practice offered easier and hyperemia-free method for lesion assessment.

Physiological changes and clinical evaluation of iFR warrants further research. Therefore, the investigators conducted this study to evaluate the functional aspects of iFR-guided provisional jailed side-branch intervention strategy and compare clinical endpoints to conventional non-iFR-guided operations.

Enrollment

50 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with acute coronary syndrome
Jailed side-branch of a vessel size > 2 mm
Vessel length > 40 mm
Lesion length < 10 mm by visual estimation

Exclusion criteria

Significant stenosis in the left main coronary artery or the main branch proximal to the stented segment
Totally occluded bifurcation lesions
Primary myocardial disease
Serum creatinine level of ≥ 2.