Fractional Flow Reserve-guided Provisional Side Branch Intervention

Study Overview
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Brief Summary
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Study purpose: To evaluate fractional flow reserve-guided side branch intervention strategy Method: Provisional side branch intervention if jailed side branch FFR<0.75

Detailed Description
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Patients with de novo, coronary bifurcation lesions with jailed side branches after successful drug-eluting stent implantation at the main branches will be prospectively and consecutively enrolled. Control group patients will be selected from the database. Jailed side branches need to have an ostial stenosis >50%, vessel size >2 mm, vessel length >40 mm and lesion length <10 mm by visual estimation. Study procedure Coronary stenting of the main branch should be performed with standard interventional techniques using drug-eluting stents. In the FFR group, pressure measurement would be performed using a 0.014 inch pressure guide wire (PressureWire, Radi Medical Systems, Uppsala, Sweden)Lesions with an FFR <0.75 are considered to have functionally significant stenosis and side branch balloon dilatation is allowed only for these lesions. It is recommended to use a smaller balloon than the side branch vessel diameter. After kissing balloon inflation, FFR will be measured again at the same site and further intervention is only recommended when FFR was <0.75 after kissing balloon dilatation. In the conventional group, the decision to treat the side branch lesion and the method of intervention are all up to the operators' discretion.

Official Title
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Physiologic Evaluation of the Provisional Side Branch Intervention Strategy for Bifurcation Lesions Using Fractional Flow Reserve

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: FFR measurement, side branch angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Jailed side branches with an ostial stenosis >50%, vessel size >2mm, vessel length >40mm and lesion length <10mm by visual estimation. Exclusion Criteria: ST elevation myocardial infarction Left main stenosis, totally occluded lesion Angiographically visible thrombus, significant lesion within the main branch proximal to the stented segment, significant distal lesion at a side branch Regional wall motion abnormalities of the stented artery and jailed side branch segments Left ventricular ejection fraction<40% Primary myocardial disease Serum creatinine >2mg/dl Predilatation of side branch before the main branch stent implantation Contraindications to adenosine
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FFR measurement, side branch angioplasty|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractional flow reserve, bifurcation, stent