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

Primary Purpose

Coronary Disease, Coronary Stenoses

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
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
Sponsored by
CHEOL WHAN LEE, M.D., Ph.D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring IVUS guided PCI, QCA guided PCI

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Korea University Anam Hospital
  • Hallym University Medical Center
  • National Health Insurance Service Ilsan Hospital
  • Gachon University Gil Medical Center
  • Pusan National University Yangsan Hospital
  • Asan Medical Center
  • Gangnam Severance Christian Hospital
  • Kangbuk Samsung Medical Center
  • The Catholic Univ. of Korea Seoul St. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

quantitative coronary angiography guided

Intravascular ultrasound guided

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Death (cardiac, vascular, non-cardiovascular)
Myocardial infarction
Stent thrombosis (definite/probable)
Stroke
Target lesion revascularization
Any revascularization
Economic analysis
cost-effectiveness of QCA- versus IVUS-guided DES implantation

Full Information

First Posted
November 22, 2016
Last Updated
March 1, 2022
Sponsor
CHEOL WHAN LEE, M.D., Ph.D
Collaborators
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT02978456
Brief Title
Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation
Acronym
GUIDE DES
Official Title
Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation: GUIDE-DES Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHEOL WHAN LEE, M.D., Ph.D
Collaborators
Biotronik SE & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Coronary Stenoses
Keywords
IVUS guided PCI, QCA guided PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1528 (Actual)

8. Arms, Groups, and Interventions

Arm Title
quantitative coronary angiography guided
Arm Type
Experimental
Arm Title
Intravascular ultrasound guided
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent
Intervention Description
In the intravascular ultrasound -guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is selected by intravascular ultrasound measurements.
Primary Outcome Measure Information:
Title
Target lesion failure
Description
the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Procedural success
Description
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).
Time Frame
24 hours
Title
Death (cardiac, vascular, non-cardiovascular)
Time Frame
12 months
Title
Myocardial infarction
Time Frame
12 months
Title
Stent thrombosis (definite/probable)
Time Frame
12 months
Title
Stroke
Time Frame
12 months
Title
Target lesion revascularization
Time Frame
12 months
Title
Any revascularization
Time Frame
12 months
Title
Economic analysis
Description
cost-effectiveness of QCA- versus IVUS-guided DES implantation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Korea University Anam Hospital
City
Anam
Country
Korea, Republic of
Facility Name
Hallym University Medical Center
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
National Health Insurance Service Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Christian Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35027418
Citation
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.
Results Reference
derived

Learn more about this trial

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

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