Coronary Disease, Coronary Stenoses
Conditions
Keywords
IVUS guided PCI, QCA guided PCI
Brief summary
The purpose of this study is to compare clinical outcomes between quantitative coronary angiography -guided and Intravascular ultrasound -guided strategy in patients with significant coronary artery disease undergoing sirolimus-eluting Orsiro/Orsiro mission stent implantation.
Interventions
DEVICEquantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent
In the quantitative coronary angiography-guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is chosen to cover the entire length of the culprit lesions according to quantitative coronary angiography measurements. Selection of the sirolimus-eluting Orsiro/Orsiro mission stent size should be guided by both quantitative coronary angiography measurement and visual estimate, and is recommended to be based on distal reference vessel diameter by quantitative coronary angiography (distal reference vessel diameter by quantitative coronary angiography plus \ 10% of distal reference vessel diameter).
DEVICEintravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent
In the intravascular ultrasound -guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is selected by intravascular ultrasound measurements.
Sponsors
Biotronik SE & Co. KG
CHEOL WHAN LEE, M.D., Ph.D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men or women at least 19years of age 2. Typical chest pain or objective evidence of myocardial ischemia suitable for elective PCI 3. Significant coronary artery lesions suitable for sirolimus-eluting Orsiro/Orsiro mission stent implantation 4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
1. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 12 months | the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death (cardiac, vascular, non-cardiovascular) | 12 months | — |
| Myocardial infarction | 12 months | — |
| Stent thrombosis (definite/probable) | 12 months | — |
| Procedural success | 24 hours | Achievement of final stent residual stenosis of less than 30% by QCA with successful deployment of at least one stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (24 hour after an index procedure). |
| Target lesion revascularization | 12 months | — |
| Any revascularization | 12 months | — |
| Economic analysis | 12 months | cost-effectiveness of QCA- versus IVUS-guided DES implantation |
| Stroke | 12 months | — |
Countries
South Korea
Outcome results
None listed