Intravascular imaging guided versus angiography guided PCI for patients with complex coronary artery lesio

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0003114
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1620

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
8) Severely calcified lesion (encircling calcium in angiography)

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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified