Precise Percutaneous Coronary Intervention for Stent OptimizatIon in treatment of Complex Lesio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007660
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 320
1)Patients >18 years old
2)Patients with stable or unstable angina and complex coronary lesions*
3)Patients who were indicated revascularization
-Diameter stenosis >90% by angiography
-Diameter stenosis with 50~90% with pre-interventional FFR =0.80
4)Patients who underwent implantation of 2nd generation drug-eluting stent
* Definitions of complex coronary lesions
[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] PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
[4] Long coronary lesions (implanted stent =38 mm in length)
[5] Multi-vessel PCI (=2 major epicardial coronary arteries treated at one PCI session)
[6] Multiple stents needed (=3 more stent per patient)
[7] In-stent restenosis lesion as target lesion
[8] Severely calcified lesion (encircling calcium in angiography)
[9] Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion
1)Target lesions not amenable for PCI by operators’ decision
2)Cardiogenic shock (Killip class IV) at presentation
3)Less than TIMI 3 flow of target vessel after index procedure
4)Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
5)Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
6)Renal insufficiency such that an additional contrast medium would be harmful for patient
7)Recent ST-segment elevation myocardial infarction (STEMI)
8)Inability to receive adenosine or nicorandil injection
9)Pregnancy or breast feeding
10)Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator’s medical judgment)
11)Unwillingness or inability to comply with the procedures described in this protocol
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with a suboptimal final post-PCI FFR <0.85
- Secondary Outcome Measures
Name Time Method Rate of target vessel failure (TVF); Rate of all-cause death;Rate of cardiac death;Rate of target vessel MI without periprocedural MI;Rate of target vessel MI with periprocedural MI;Rate of target lesion revascularization (TLR);Rate of target vessel revascularization (TVR);Rate of any MI;Rate of any revascularization;Rate of stent thrombosis;FFR gain between pre- and post-interventional stages;Trans-stent FFR gradient;Post-interventional non-hyperemic pressure ratios;Incidence of contrast-induced nephropathy;Total procedure time;Total amount of contrast dose;Total fluoroscopy time;Total amount of radiation dose