![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Seoul National University Hospital |
---|---|
Information provided by: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00351780 |
Study purpose: To evaluate fractional flow reserve-guided side branch intervention strategy Method: Provisional side branch intervention if jailed side branch FFR<0.75
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: FFR measurement, side branch angioplasty |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Physiologic Evaluation of the Provisional Side Branch Intervention Strategy for Bifurcation Lesions Using Fractional Flow Reserve |
Study Start Date: | June 2004 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 110-799 |
Principal Investigator: | Bon-Kwon Koo, MD, PhD | Seoul National University Hospital |
Study ID Numbers: | H-0602-027-167 |
Study First Received: | July 12, 2006 |
Last Updated: | April 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00351780 |
Health Authority: | Korea: Food and Drug Administration |
fractional flow reserve bifurcation stent |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |