Coronary Bifurcation Lesions
Conditions
Keywords
Provisional side-branch intervention strategy, iFR, Pilot study
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.
Interventions
DEVICEiFR 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
DEVICEConventional
Other diagnostic devices (including FFR and angiography)
Sponsors
Nova-Med Medical Research Association
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological evaluation of iFR-guided intervention | 6-month | iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | 30-day | — |
| Fluoroscopy time | 30-day | — |
| In-hospital heart failure class | 30-day | — |
| length of hospital stay | 6-month | — |
| Post-PCI angina | 6-month | Comparison of the incidence of angina after performing PCI in both the iFR and conventional groups |
| Ejection fraction at 6 months' post operation | 6-month | — |
| The amount of dye injection for angiography | 30-day | — |
| 6-month heart failure class | 6-month | — |
Outcome results
None listed