Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation

Coronary Disease Clinical Trial

— GUIDE DES  

Official title:

Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation: GUIDE-DES Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02978456
• Other study ID #: AMCCV2016-24
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 23, 2017
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Coronary Disease
• Coronary Stenoses
• Coronary Stenosis

Intervention

Device:
• quantitative 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).
• intravascular 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
CHEOL WHAN LEE, M.D., Ph.D	Biotronik SE & Co. KG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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