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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003114

Enrollment

1620

Registered

2018-08-24

Start date

2018-05-29

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Patients will be randomized to either the Intravascular imaging-guidance group or angiography only-guidance group at the time of enrollment with 2:1 ratio. The choice of intravascu

s discretion in the intravascular imaging group. The PCI procedure in the angiography-guided PCI group will be performed as standard procedure.

Eligibility

Sex/Gender

All

Inclusion 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 8) Severely calcified lesion (encircling calcium in angiography)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Target vessel failure	—

Secondary

Measure	Time frame
All-cause death;Cardiac death;Target vessel MI without periprocedural MI;Target vessel MI with periprocedural MI;Any MI without periprocedural MI;Any MI with periprocedural MI;Target lesion revascularization;Target vessel revascularization;Any revascularization;Total procedure time;Total amount of contrast use;Incidence of contrast-induced nephropathy	—

Countries

Korea, Republic of

Contacts

Public ContactJoo Myung Lee

Samsung Medical Center

Outcome results