Percutaneous Transluminal Coronary Angioplasty
Conditions
Keywords
bioresorbable vascular scaffold, coronary artery disease
Brief summary
The purpose of this study is to compare clinical outcomes between QCA(quantitative coronary angiography)-guided and imaging-guided strategy in patients with native coronary artery disease undergoing Bioresorbable Vascular Scaffold implantation.
Interventions
PROCEDUREQCA and Aspirin
QCA(quantitative coronary angiography) guided BVS implantation and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day\[or ticagrelor 90mg po bid\]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.
PROCEDUREQCA and Clopidogrel
QCA(quantitative coronary angiography) guided BVS implantation and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day\[or ticagrelor 90mg po bid\]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.
PROCEDUREImaging guided and Aspirin
BVS size and length were selected by on-line IVUS(intravascular ultrasound) or OCT(optical coherence tomography) measurements and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day\[or ticagrelor 90mg po bid\]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.
PROCEDUREImaging guided and Clopidogrel
BVS size and length were selected by on-line IVUS(intravascular ultrasound) or OCT(optical coherence tomography) measurements and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day\[or ticagrelor 90mg po bid\]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women at least 18 years of age * Typical chest pain or objective evidence of myocardial ischemia suitable for elective percutaneous coronary intervention * Native coronary artery lesions with lesion length ≤ 50mm and reference vessel diameter of 2.3 - 3.75mm by QCA(quantitative coronary angiography) assessment * 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
* Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 1 year | 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 |
|---|---|---|
| Any revascularization | 1 year and 5 years | — |
| Device success | 1 day | Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA). |
| Procedural success | 24 hours | Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA with successful delivery and deployment of at least one study scaffold/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 myocardial infarction or repeat target lesion revascularization during the hospital stay (24 hour after an index procedure). |
| Death | 1 year and 5 years | — |
| Target lesion revascularization | 1 year and 5 years | — |
| Scaffold thrombosis | 1 year and 5 years | — |
| Stroke | 1 year and 5 years | — |
| Target lesion failure | 1 year and 5 years | cardiac death, target vessel myocardial infarction or ischemia-driven target lesion failure |
| event rate of net clinical events | 5 years | defined as composite event of cardiovascular death, myocardial infarction, stroke, clinically relevant bleeding |
| Myocardial infarction | 1 year and 5 years | — |
Countries
South Korea
Outcome results
None listed