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

December 31, 2024 updated by: CHEOL WHAN LEE, M.D., Ph.D

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1528

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anam, Korea, Republic of
        • Korea University Anam Hospital
      • Gyeonggi-do, Korea, Republic of
        • Hallym University Medical Center
      • Ilsan, Korea, Republic of
        • National Health Insurance Service Ilsan Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Kangbuk Samsung Medical Center
      • Seoul, Korea, Republic of
        • Gangnam Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Biotronik SE & Co. KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2017

Primary Completion (Actual)

August 23, 2022

Study Completion (Actual)

August 23, 2022

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimated)

December 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 31, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2016-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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