Coronary Stenosis
Conditions
Keywords
BioResorbable Scaffold, Quantitative Coronary Angiography, Intravascular Imaging
Brief summary
The objective of this trial is to compare clinical outcomes between imaging-guided and QCA-guided strategy in patients with native coronary artery disease undergoing BRS implantation.
Detailed description
The investigators hypothesized that intravascular imaging-guided BRS implantation is superior to QCA-guided BRS implantation with respect to target lesion failure in patients with native coronary artery disease.
Interventions
DEVICEquantitative coronary angiography guided Bioresorbable scaffold implantation
In the QCA-guided group, BRS size and length were chosen by both visual estimation and on-line QCA, and adjunct high-pressure dilation is routinely performed to achieve angiographic residual diameter stenosis less than 30% by QCA and absence of angiographically visible dissections.
DEVICEimaging guided Bioresorbable scaffold implantation
In the imaging-guided group, imaging is used at any step of percutaneous coronary intervention(PCI) before, during, or after PCI. Final image examination after PCI is mandatory.
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
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
* Men or women at least 19 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 less and reference vessel diameter of 2.5 \ 3.75mm by 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 |
|---|---|---|
| Procedural success | 24 hours after an index procedure | Achievement of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography with successful delivery and deployment of at least one study scaffold 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. |
| Death | 1 year, and 5 years | cardiac, vascular, non-cardiovascular |
| Myocardial infarction | 1 year, and 5 years | — |
| Scaffold thrombosis | 1 year, and 5 years | — |
| Stroke | 1 year, and 5 years | — |
| Device success | 1 hour after an index procedure | Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA). |
| Any revascularization | 1 year, and 5 years | — |
| Target lesion failure (TLR) | 1 year, and 5 years | cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization |
| A composite event | 1 year, and 5 years | a composite event of cardiac death, target vessel myocardial infarction, stroke, or clinically significant bleeding(clinically significant bleeding by Bleeding Academic Research Consortium (BARC) type 2,3,4,5) |
| In-scaffold restenosis on coronary CT angiography | 1 year, and 5 years | — |
| Target lesion revascularization | 1 year, and 5 years | — |
Countries
South Korea
Outcome results
None listed