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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quantitative coronary angiography guided | Experimental |
| |
| Intravascular ultrasound guided | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | 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). | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Angiographic exclusion criteria: any of the followings 1)Bypass graft lesions 2)Impaired delivery of IVUS is expected:
Previous percutaneous coronary intervention within 6 months before the index procedure
Previous BVS (bioresorbable vascular scaffold) implantation
Left ventricular ejection fraction (LVEF) < 30%
Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
Persistent thrombocytopenia (platelet count <100,000/µl)
Any history of hemorrhagic stroke or intracranial hemorrhage, Transient ischemic attack or ischemic stroke within the past 6 months
A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor)
Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
Life expectancy < 1 years for any non-cardiac or cardiac causes
Unwillingness or inability to comply with the procedures described in this protocol.
Patient's pregnant or breast-feeding or child-bearing potential.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Anam | South Korea | ||||
| Hallym University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38477913 | Derived | Lee PH, Hong SJ, Kim HS, Yoon YW, Lee JY, Oh SJ, Lee JS, Kang SJ, Kim YH, Park SW, Lee SW, Lee CW; GUIDE-DES Trial Research Group. Quantitative Coronary Angiography vs Intravascular Ultrasonography to Guide Drug-Eluting Stent Implantation: A Randomized Clinical Trial. JAMA Cardiol. 2024 May 1;9(5):428-435. doi: 10.1001/jamacardio.2024.0059. | |
| 35027418 |
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|
| intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent | Device | In the intravascular ultrasound -guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is selected by intravascular ultrasound measurements. |
|
| Death (cardiac, vascular, non-cardiovascular) | 12 months |
| Myocardial infarction | 12 months |
| Stent thrombosis (definite/probable) | 12 months |
| Stroke | 12 months |
| Target lesion revascularization | 12 months |
| Any revascularization | 12 months |
| Economic analysis | cost-effectiveness of QCA- versus IVUS-guided DES implantation | 12 months |
| Gyeonggi-do |
| South Korea |
| National Health Insurance Service Ilsan Hospital | Ilsan | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Gangnam Severance Christian Hospital | Seoul | South Korea |
| Kangbuk Samsung Medical Center | Seoul | South Korea |
| Lee PH, Hong SJ, Kim HS, Yoon YW, Lee JY, Oh SJ, Kang SJ, Kim YH, Park SW, Lee SW, Lee CW; GUIDE-DES Trial Research Group. Quantitative coronary angiography versus intravascular ultrasound guidance for drug-eluting stent implantation (GUIDE-DES): study protocol for a randomised controlled non-inferiority trial. BMJ Open. 2022 Jan 13;12(1):e052215. doi: 10.1136/bmjopen-2021-052215. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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