Coronary Disease Clinical Trial
— GUIDE DESOfficial title:
Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation: GUIDE-DES Trial
Verified date | March 2022 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 1528 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 exclusion criteria: any of the followings 1)Bypass graft lesions 2)Impaired delivery of IVUS is expected: - Extreme angulation (=90°) proximal to or within the target lesion. - Excessive tortuosity (= two 45° angles) proximal to or within the target lesion. - Heavy calcification proximal to or within the target lesion. 2. Previous percutaneous coronary intervention within 6 months before the index procedure 3. Previous BVS (bioresorbable vascular scaffold) implantation 4. Left ventricular ejection fraction (LVEF) < 30% 5. 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. 6. Persistent thrombocytopenia (platelet count <100,000/µl) 7. Any history of hemorrhagic stroke or intracranial hemorrhage, Transient ischemic attack or ischemic stroke within the past 6 months 8. A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor) 9. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure. 10. 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. 11. 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. 12. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal). 13. Life expectancy < 1 years for any non-cardiac or cardiac causes 14. Unwillingness or inability to comply with the procedures described in this protocol. 15. Patient's pregnant or breast-feeding or child-bearing potential. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Anam Hospital | Anam | |
Korea, Republic of | Hallym University Medical Center | Gyeonggi-do | |
Korea, Republic of | National Health Insurance Service Ilsan Hospital | Ilsan | |
Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
Korea, Republic of | Pusan National University Yangsan Hospital | Pusan | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Gangnam Severance Christian Hospital | Seoul | |
Korea, Republic of | Kangbuk Samsung Medical Center | Seoul | |
Korea, Republic of | The Catholic Univ. of Korea Seoul St. Mary's hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
CHEOL WHAN LEE, M.D., Ph.D | Biotronik SE & Co. KG |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Death (cardiac, vascular, non-cardiovascular) | 12 months | ||
Secondary | Myocardial infarction | 12 months | ||
Secondary | Stent thrombosis (definite/probable) | 12 months | ||
Secondary | Stroke | 12 months | ||
Secondary | Target lesion revascularization | 12 months | ||
Secondary | Any revascularization | 12 months | ||
Secondary | Economic analysis | cost-effectiveness of QCA- versus IVUS-guided DES implantation | 12 months |
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