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Completed

NCT Number: NCT03027830

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iFR pressure-wire

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

Device

Other diagnostic devices (including FFR and angiography)

Primary outcomes

  1. Physiological evaluation of iFR-guided intervention

    Time frame: 6-month

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

Secondary outcomes

  1. length of hospital stay

    Time frame: 6-month

  2. Procedure time

    Time frame: 30-day

  3. Fluoroscopy time

    Time frame: 30-day

  4. In-hospital heart failure class

    Time frame: 30-day

  5. 6-month heart failure class

    Time frame: 6-month

  6. Post-PCI angina

    Time frame: 6-month

    Comparison of the incidence of angina after performing PCI in both the iFR and conventional groups

  7. Ejection fraction at 6 months' post operation

    Time frame: 6-month

  8. The amount of dye injection for angiography

    Time frame: 30-day

Sponsors and collaborators

Lead sponsor

Nova-Med Medical Research Association

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2017
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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