NCT02978456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,528

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

5.5 years

First QC Date

November 22, 2016

Last Update Submit

December 31, 2024

Conditions

Coronary DiseaseCoronary Stenoses

Keywords

IVUS guided PCIQCA guided PCI

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (8)

  • Procedural success

    24 hours

  • Death (cardiac, vascular, non-cardiovascular)

    12 months

  • Myocardial infarction

    12 months

  • Stent thrombosis (definite/probable)

    12 months

  • Stroke

    12 months

  • +3 more secondary outcomes

Study Arms (2)

quantitative coronary angiography guided

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

Intravascular ultrasound guided

ACTIVE COMPARATOR
Device: intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent

Interventions

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).

quantitative coronary angiography guided
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.

Intravascular ultrasound guided

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Korea University Anam Hospital

Anam, South Korea

Location

Hallym University Medical Center

Gyeonggi-do, South Korea

Location

National Health Insurance Service Ilsan Hospital

Ilsan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Gangnam Severance Christian Hospital

Seoul, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 38477913DERIVED

  • 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.

    PMID: 35027418DERIVED

MeSH Terms

Conditions

Coronary DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor, Division of Cardiology, Department of Internal Medicine

Study Record Dates

First Submitted

November 22, 2016

First Posted

December 1, 2016

Study Start

February 23, 2017

Primary Completion

August 23, 2022

Study Completion

August 23, 2022

Last Updated

January 1, 2025

Record last verified: 2024-12

Locations

KR(6)