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Completed

NCT Number: NCT02978456

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital, Anam, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women at least 19years of age
  • Typical chest pain or objective evidence of myocardial ischemia suitable for elective PCI
  • Significant coronary artery lesions suitable for sirolimus-eluting Orsiro/Orsiro mission stent implantation
  • 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

  • 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.
  • Previous percutaneous coronary intervention within 6 months before the index procedure
  • Previous BVS (bioresorbable vascular scaffold) implantation
  • Left ventricular ejection fraction (LVEF) < 30%
  • 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.
  • Persistent thrombocytopenia (platelet count <100,000/µl)
  • Any history of hemorrhagic stroke or intracranial hemorrhage, Transient ischemic attack or ischemic stroke within the past 6 months
  • A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor)
  • Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
  • 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.
  • 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.
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
  • Life expectancy < 1 years for any non-cardiac or cardiac causes
  • Unwillingness or inability to comply with the procedures described in this protocol.
  • Patient's pregnant or breast-feeding or child-bearing potential.

Treatment and study plan

quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent

Device

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

Device

In the intravascular ultrasound -guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is selected by intravascular ultrasound measurements.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CHEOL WHAN LEE, M.D., Ph.D

Other

Collaborators

  • Biotronik SE & Co. KG

Registry information

Official study title

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

Acronym: GUIDE DES

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2016
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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