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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02978456
Recruitment Status : Unknown
Verified March 2022 by CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : December 1, 2016
Last Update Posted : March 2, 2022
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 23, 2017
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Target lesion failure [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 12 months ]
  3. Myocardial infarction [ Time Frame: 12 months ]
  4. Stent thrombosis (definite/probable) [ Time Frame: 12 months ]
  5. Stroke [ Time Frame: 12 months ]
  6. Target lesion revascularization [ Time Frame: 12 months ]
  7. Any revascularization [ Time Frame: 12 months ]
  8. Economic analysis [ Time Frame: 12 months ]
    cost-effectiveness of QCA- versus IVUS-guided DES implantation


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978456


Locations
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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, Korea, Republic of
Sponsors and Collaborators
CHEOL WHAN LEE, M.D., Ph.D
Biotronik SE & Co. KG
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: December 1, 2016    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Asan Medical Center:
IVUS guided PCI
QCA guided PCI
Additional relevant MeSH terms:
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Coronary Disease
Coronary Stenosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Temsirolimus
MTOR Inhibitors
Anti-Bacterial Agents
 Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action