NCT03027830

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

Physiological and Clinical Assessment of the Provisional Side-branch Intervention Strategy for Coronary Bifurcation Lesions Using iFR Pressure Wires

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Nova-Med Medical Research Association · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Coronary Bifurcation Lesions

Interventions

Type	Name	Description
DEVICE	iFR pressure-wire	The instantaneous wave-free ratio (iFR) as an adenosine-independent index of coronary stenosis severity, calculated as the ratio between the distal trans-stenotic pressure and the proximal coronary pressure during a specific diastolic wave-free period
DEVICE	Conventional	Other diagnostic devices (including FFR and angiography)

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2017-01-23
• Last updated: 2017-01-23