Fractional Flow Reserve-guided Provisional Side Branch Intervention
Coronary Artery Disease
Device: FFR measurement, side branch angioplasty
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Physiologic Evaluation of the Provisional Side Branch Intervention Strategy for Bifurcation Lesions Using Fractional Flow Reserve|
|Study Start Date:||June 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351780
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-799|
|Principal Investigator:||Bon-Kwon Koo, MD, PhD||Seoul National University Hospital|