Fractional Flow Reserve-guided Provisional Side Branch Intervention

Phase 4

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00351780
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2006-07-12
• Study First Submitted QC: 2006-07-12
• Study First Posted: 2006-07-13
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-15
• Last Update Posted: 2011-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of