Fractional Flow Reserve-guided Provisional Side Branch Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351780
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : July 18, 2011
Information provided by:
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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: FFR measurement, side branch angioplasty Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00351780

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University Hospital

Responsible Party: Seoul National University Hospital Identifier: NCT00351780     History of Changes
Other Study ID Numbers: H-0602-027-167
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: July 18, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Hospital:
fractional flow reserve

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases