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

Not Applicable

Completed

• Conditions: Coronary Disease; Coronary Stenoses
• Interventions: Device: quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent; Device: intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent

• Registration Number: NCT02978456
• Lead Sponsor: CHEOL WHAN LEE, M.D., Ph.D

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-12-01
• Study Start: 2017-02-23
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1528

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
quantitative coronary angiography guided	quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent	-
Intravascular ultrasound guided	intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent	-

Primary Outcome Measures

Name	Time	Method
Target lesion failure	12 months	the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.

Secondary Outcome Measures

Name	Time	Method
Target lesion revascularization	12 months
Economic analysis	12 months	cost-effectiveness of QCA- versus IVUS-guided DES implantation
Procedural success	24 hours	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).
Stent thrombosis (definite/probable)	12 months
Stroke	12 months
Any revascularization	12 months
Myocardial infarction	12 months
Death (cardiac, vascular, non-cardiovascular)	12 months

Trial Locations

Locations (6)

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

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Christian Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of