NCT03027830

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

January 18, 2017

Last Update Submit

January 20, 2017

Conditions

Coronary Bifurcation Lesions

Keywords

Provisional side-branch intervention strategyiFRPilot study

Outcome Measures

Primary Outcomes (1)

  • Physiological evaluation of iFR-guided intervention

    iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.

    6-month

Secondary Outcomes (8)

  • length of hospital stay

    6-month

  • Procedure time

    30-day

  • Fluoroscopy time

    30-day

  • In-hospital heart failure class

    30-day

  • 6-month heart failure class

    6-month

  • +3 more secondary outcomes

Study Arms (2)

iFR pressure-wire

EXPERIMENTAL
Device: iFR pressure-wire

Conventional

ACTIVE COMPARATOR
Device: Conventional

Interventions

iFR pressure-wireDEVICE

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

iFR pressure-wire
ConventionalDEVICE

Other diagnostic devices (including FFR and angiography)

Conventional

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 23, 2017

Study Start

March 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share