Status:
ACTIVE_NOT_RECRUITING
Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease
Lead Sponsor:
Samsung Medical Center
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The aim of the study is to compare clinical outcomes between intravascular imaging-guided versus angiography-guided percutaneous coronary intervention (PCI) in complex lesions.
Detailed Description
After introduction of the 2nd generation drug-eluting stents (DES), the rates of device-related failure or target lesion failure such as restenosis and stent thrombosis has been markedly decreased, co...
Eligibility Criteria
Inclusion
- Subject age ≥19 years old
- Coronary artery disease requiring PCI
- Patients with complex lesion
- True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
- Chronic total occlusion (≥3 months) as target lesion
- Unprotected LM disease PCI (LM ostium, body, distal LM bifurcation including non-true bifurcation)
- Long coronary lesions (implanted stent ≥38 mm in length)
- Multi-vessel PCI (≥2 vessels treated at one PCI session)
- Multiple stents needed (≥3 more stent per patient)
- In-stent restenosis lesion as target lesion
- Severely calcified lesion (encircling calcium in angiography)
- Ostial coronary lesion (LAD, LCX, RCA)
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion
- Target lesions not amenable for PCI by operators' decision
- Cardiogenic shock (Killip class IV) at presentation
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
- 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.
Key Trial Info
Start Date :
May 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
1639 Patients enrolled
Trial Details
Trial ID
NCT03381872
Start Date
May 10 2018
End Date
December 31 2025
Last Update
August 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Samsung Medical Center
Seoul, South Korea, 06351