Status:
COMPLETED
Optimal Stenting Strategy For True Bifurcation Lesions
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
It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.
Detailed Description
The outcome of percutaneous coronary intervention of bifurcation lesions with bare-metal stents is hindered by increased rates of procedural complications and long-term major adverse cardiac events co...
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 seems to be covered with =\< 2 stents
- Side branch : \>= 2.0 mm in vessel size, \>= 50% in diameter stenosis, and \< 20 mm in lesion length by visual estimation, in which the lesion seems to be covered with single stent
Exclusion
- History of bleeding diathesis or coagulopathy
- Pregnant
- Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus and paclitaxel
- 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
- Chronic total occlusion
- TIMI flow =\< grade 2 in the side branch
- Renal dysfunction, creatinine \>= 2.0mg/dL
- Contraindication to aspirin, clopidogrel or cilostazol
- LV ejection fraction =\< 35%
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00693251
Start Date
January 1 2008
End Date
June 1 2015
Last Update
November 17 2015
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
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
Kangwon University Hospital
Chuncheon, South Korea