Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351780
Status:
COMPLETED
Last Update Posted:
2011-07-18
First Post:
2006-07-12
Brief Title:
Fractional Flow Reserve-guided Provisional Side Branch Intervention
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Physiologic Evaluation of the Provisional Side Branch Intervention Strategy for Bifurcation Lesions Using Fractional Flow Reserve
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study purpose To evaluate fractional flow reserve-guided side branch intervention strategy Method Provisional side branch intervention if jailed side branch FFR075
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 0014 inch pressure guide wire PressureWire Radi Medical Systems Uppsala SwedenLesions with an FFR 075 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 075 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
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 0014 inch pressure guide wire PressureWire Radi Medical Systems Uppsala SwedenLesions with an FFR 075 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 075 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None