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Clinical Trials/KCT0003114
KCT0003114
Recruiting
未知

Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention

Samsung Medical Center0 sites1,620 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Diseases of the circulatory system
Sponsor
Samsung Medical Center
Enrollment
1620
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • ?Subject age 19\-85 years old
  • ?Coronary artery disease requiring PCI
  • ?Patients with complex lesion
  • 1\) True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1\) with side branch \=2\.5mm size
  • 2\) Chronic total occlusion (\=3 months) as target lesion
  • 3\) Unprotected LM disease PCI (LM os, body, distal LM bifurcation including non\-true bifurcation)
  • 4\) Lesion needed \=2 more overlapping stents or lesion length \=30mm by visual estimation
  • 5\) Multi\-vessel PCI (\=2 vessels treated at one PCI session)
  • 6\) Multiple stent needed (\=3 more stent per patient)
  • 7\) In\-stent restenosis lesion as target lesion

Exclusion Criteria

  • ?Target lesions not amenable for PCI by operators decision
  • ?Cardiogenic shock (Killip class IV) at presentation
  • ?Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
  • ?Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
  • ?Pregnancy or breast feeding
  • ?Non\-cardiac co\-morbid conditions are present with life expectancy \<1 year or that may result in protocol non\-compliance (per site investigator’s medical judgment)
  • ?Unwillingness or inability to comply with the procedures described in this protocol.

Outcomes

Primary Outcomes

Not specified

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