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

January 20, 2017 updated by: Nova-Med Medical Research Association

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional
Device: Conventional
Other diagnostic devices (including FFR and angiography)
Experimental: iFR pressure-wire
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological evaluation of iFR-guided intervention
Time Frame: 6-month
iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.
6-month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova-Med Medical Research Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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