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

Not Applicable

Completed

• Conditions: Coronary Bifurcation Lesions
• Interventions: Device: iFR pressure-wire; Device: Conventional

• Registration Number: NCT03027830
• Lead Sponsor: Nova-Med Medical Research Association

Brief 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.

Study Timeline

• Study Start: 2014-03
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-20
• Last Update Submitted: 2017-01-20
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iFR pressure-wire	iFR pressure-wire	-
Conventional	Conventional	-

Primary Outcome Measures

Name	Time	Method
Physiological evaluation of iFR-guided intervention	6-month	iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	6-month
Procedure time	30-day
Fluoroscopy time	30-day
Post-PCI angina	6-month	Comparison of the incidence of angina after performing PCI in both the iFR and conventional groups
6-month heart failure class	6-month
In-hospital heart failure class	30-day
Ejection fraction at 6 months' post operation	6-month
The amount of dye injection for angiography	30-day