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

NCT ID: NCT03027830

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-01-31

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.

Conditions

Coronary Bifurcation Lesions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

iFR pressure-wire

Group Type: EXPERIMENTAL

iFR pressure-wire

Intervention Type: DEVICE

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

Conventional

Group Type: ACTIVE_COMPARATOR

Conventional

Intervention Type: DEVICE

Other diagnostic devices (including FFR and angiography)

Interventions

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

Intervention Type: DEVICE

Conventional

Other diagnostic devices (including FFR and angiography)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova-Med Medical Research Association

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id