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Fractional Flow Reserve-guided Provisional Side Branch Intervention

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00351780
First received: July 12, 2006
Last updated: July 15, 2011
Last verified: July 2011
  Purpose

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 4

Study Type: Interventional
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

Further study details as provided by Seoul National University Hospital:

Estimated Enrollment: 100
Study Start Date: June 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00351780

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

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00351780     History of Changes
Other Study ID Numbers: H-0602-027-167
Study First Received: July 12, 2006
Last Updated: July 15, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
fractional flow reserve
bifurcation
stent

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

ClinicalTrials.gov processed this record on November 20, 2014