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Status:

COMPLETED

Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch

Lead Sponsor:

Seung-Jung Park

Collaborating Sponsors:

CardioVascular Research Foundation, Korea

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

Brief Summary

Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.

Detailed Description

Among the bifurcation type, bifurcation lesion without significant side branch stenosis (\<50%) usually did not require side branch stenting, but owing to several putative mechanism including dissecti...

Eligibility Criteria

Inclusion

  • Clinical
  • Patients with angina and documented ischemia or patients with documented silent ischemia
  • Patients who are eligible for intracoronary stenting
  • Age \>18 years, \<75 ages
  • Angiographic
  • De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0
  • Main vessel : \>= 2.5 mm in vessel size, \>= 50% in diameter stenosis and =\< 50 mm in lesion length by visual estimation, in which the lesion is covered with =\< 2 stents
  • Side branch :\>= 2.0 mm in vessel size and \< 50% diameter stenosis by visual estimation

Exclusion

  • History of bleeding diathesis or coagulopathy
  • Pregnant
  • Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus, paclitaxel and zotarolimus
  • Limited life-expectancy (less than 1 year) due to combined serious disease
  • ST-elevation acute myocardial infarction =\< 2 weeks
  • Characteristics of lesion:
  • Left main disease
  • In-stent restenosis
  • Graft vessels
  • TIMI flow =\< grade 2 in the side branch
  • Chronic total occlusion
  • Renal dysfunction, creatinine \>= 2.0mg/dL
  • Contraindication to aspirin, clopidogrel or cilostazol

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

504 Patients enrolled

Trial Details

Trial ID

NCT00694005

Start Date

January 1 2008

End Date

January 1 2015

Last Update

November 20 2015

Active Locations (11)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (11 locations)

1

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

2

Busan Saint Mary's Hospital

Busan, South Korea

3

Cheongju Saint Mary's Hospital

Cheongju-si, South Korea

4

Chungnam National University Hospital

Daejeon, South Korea