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

• Sponsor: CHEOL WHAN LEE, M.D., Ph.D (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02978456
• Collaborator: Biotronik SE & Co. KG (Industry)
• Enrollment: 1,528
• Locations: 9
• Arms: 2
• Anticipated Duration (Months): 71.2
• Patients Per Site: 169.8
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease; Coronary Stenoses	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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1528 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation: GUIDE-DES Trial
• Actual Study Start Date: Feb 23, 2017
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: quantitative coronary angiography guided	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).
Active Comparator: Intravascular ultrasound guided	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. Death (cardiac, vascular, non-cardiovascular) [12 months]

3. Myocardial infarction [12 months]

4. Stent thrombosis (definite/probable) [12 months]

5. Stroke [12 months]

6. Target lesion revascularization [12 months]

7. Any revascularization [12 months]

8. Economic analysis [12 months]

   cost-effectiveness of QCA- versus IVUS-guided DES implantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Previous percutaneous coronary intervention within 6 months before the index procedure

2. Previous BVS (bioresorbable vascular scaffold) implantation

3. Left ventricular ejection fraction (LVEF) < 30%

4. 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.

5. Persistent thrombocytopenia (platelet count <100,000/µl)

6. Any history of hemorrhagic stroke or intracranial hemorrhage, Transient ischemic attack or ischemic stroke within the past 6 months

7. A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor)

8. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.

9. 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.

10. 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.

11. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).

12. Life expectancy < 1 years for any non-cardiac or cardiac causes

13. Unwillingness or inability to comply with the procedures described in this protocol.

14. Patient's pregnant or breast-feeding or child-bearing potential.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Anam		Korea, Republic of
2	Hallym University Medical Center	Gyeonggi-do		Korea, Republic of
3	National Health Insurance Service Ilsan Hospital	Ilsan		Korea, Republic of
4	Gachon University Gil Medical Center	Incheon		Korea, Republic of
5	Pusan National University Yangsan Hospital	Pusan		Korea, Republic of
6	Asan Medical Center	Seoul		Korea, Republic of
7	Gangnam Severance Christian Hospital	Seoul		Korea, Republic of
8	Kangbuk Samsung Medical Center	Seoul		Korea, Republic of
9	The Catholic Univ. of Korea Seoul St. Mary's hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• CHEOL WHAN LEE, M.D., Ph.D
• Biotronik SE & Co. KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CHEOL WHAN LEE, M.D., Ph.D, professor, Division of Cardiology, Department of Internal Medicine, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT02978456
• Other Study ID Numbers: AMCCV2016-24
• First Posted: Dec 1, 2016
• Last Update Posted: Mar 2, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CHEOL WHAN LEE, M.D., Ph.D, professor, Division of Cardiology, Department of Internal Medicine, Asan Medical Center: IVUS guided PCI; QCA guided PCI
• Additional relevant MeSH terms: Coronary Disease; Coronary Stenosis; Sirolimus

Study Results

No Results Posted as of Mar 2, 2022