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Coronary DiseaseGUIDE DESNCT02978456

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

A study testing quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent and intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent in people with Coronary Disease and Coronary Stenoses, run by CHEOL WHAN LEE, M.D., Ph.D at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Disease, Coronary Stenoses
What is being tested?
quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent and intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,528 participants
Where
6 sitesSouth Korea
Study dates
23 Feb 2017to 23 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • Korea University Anam Hospital

    Anam

  • Hallym University Medical Center

    Gyeonggi-do

  • National Health Insurance Service Ilsan Hospital

    Ilsan

  • Asan Medical Center

    Seoul

  • Gangnam Severance Christian Hospital

    Seoul

  • Kangbuk Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent, intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent
Keywords
IVUS guided PCI, QCA guided PCI
Medical subject headings
Coronary Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 stentDevice

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

Study groups in NCT02978456
Study groupRoleWhat they receive
quantitative coronary angiography guidedExperimentalNot described
Receives: Device: quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent
Intravascular ultrasound guidedActive comparatorNot described
Receives: Device: intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (8)

  1. 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).

    Measured: 24 hours

  2. Death (cardiac, vascular, non-cardiovascular)

    Measured: 12 months

  3. Myocardial infarction

    Measured: 12 months

  4. Stent thrombosis (definite/probable)

    Measured: 12 months

  5. Stroke

    Measured: 12 months

  6. Target lesion revascularization

    Measured: 12 months

  7. Any revascularization

    Measured: 12 months

  8. Economic analysis

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2016 (estimated)
  2. Study start23 Feb 2017
  3. Primary completion23 Aug 2022
  4. Study completion23 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,528 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02978456
Sponsor's protocol ID
AMCCV2016-24
Acronym
GUIDE DES
Status last verified
Dec 2024
First submitted
22 Nov 2016
Last updated
1 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee PH, Hong SJ, Kim HS, Yoon YW, Lee JY, Oh SJ, Lee JS, Kang SJ, Kim YH, Park SW, Lee SW, Lee CW; GUIDE-DES Trial Research Group. Quantitative Coronary Angiography vs Intravascular Ultrasonography to Guide Drug-Eluting Stent Implantation: A Randomized Clinical Trial. JAMA Cardiol. 2024 May 1;9(5):428-435. doi: 10.1001/jamacardio.2024.0059.

    PubMed 38477913

  • Lee PH, Hong SJ, Kim HS, Yoon YW, Lee JY, Oh SJ, Kang SJ, Kim YH, Park SW, Lee SW, Lee CW; GUIDE-DES Trial Research Group. Quantitative coronary angiography versus intravascular ultrasound guidance for drug-eluting stent implantation (GUIDE-DES): study protocol for a randomised controlled non-inferiority trial. BMJ Open. 2022 Jan 13;12(1):e052215. doi: 10.1136/bmjopen-2021-052215.

    PubMed 35027418

Questions about this trial

What is this clinical trial studying?

A study testing quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent and intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent in people with Coronary Disease and Coronary Stenoses, run by CHEOL WHAN LEE, M.D., Ph.D at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion failure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02978456, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.

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