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Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PCI with IVUS guidance
PCI without IVUS guidance
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 20 years old or older
  • Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia
  • Non-emergent conditions
  • Patients with signed informed consent
  • Stent length ≥28 mm by angiography estimation
  • Significant coronary artery stenosis (> 50% by visual estimate) considered for coronary revascularization with stent implantation
  • Reference vessel diameter of 2.5 to 4.0 mm by operator assessment

Exclusion Criteria:

  • Acute ST elevation myocardial infarction within 48 hours
  • Contraindication to anti-platelet agents & bleeding history within prior 3 months
  • Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus or other -limus group

  • Prior history of the following presentations

    • Cerebral vascular accident (not including transient ischemic attack)
    • Peripheral artery occlusive diseases
    • Thromboembolic disease
    • Stent thrombosis
  • Age > 80 years old
  • Severe hepatic dysfunction (3 times normal reference values)
  • Significant renal dysfunction (Serum creatinine > 2.0 mg/dl)
  • Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
  • Cardiogenic shock
  • LVEF < 40%
  • Pregnant women or women with potential childbearing
  • Life expectancy < 1 year
  • Left main disease requiring PCI
  • Bifurcation lesion with 2-stent technique
  • Chronic total occlusion
  • Presence of previously implanted DES within 6-month
  • In-stent restenosis lesion

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCI with IVUS guidance

PCI without IVUS guidance

Arm Description

PCI(percutaneous coronary intervention) with IVUS(IntraVascular UltraSound) group

PCI(percutaneous coronary intervention) group

Outcomes

Primary Outcome Measures

Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance
Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance

Secondary Outcome Measures

Full Information

First Posted
March 3, 2011
Last Updated
July 25, 2016
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01308281
Brief Title
Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)
Official Title
Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed as a prospective, randomized, multi-center trial to demonstrate an inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting stents(EES) at long lesions(> 28 mm) in clinical outcomes at 12 months as a primary objective and safety of 6- month dual antiplatelet therapy following EES implantation in comparison with a 12-month dual antiplatelet therapy.
Detailed Description
The primary purpose of this study is to investigate the impact of IVUS guidance on the clinical outcomes after implantation of DES at long lesions > 28 mm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1079 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCI with IVUS guidance
Arm Type
Experimental
Arm Description
PCI(percutaneous coronary intervention) with IVUS(IntraVascular UltraSound) group
Arm Title
PCI without IVUS guidance
Arm Type
Active Comparator
Arm Description
PCI(percutaneous coronary intervention) group
Intervention Type
Procedure
Intervention Name(s)
PCI with IVUS guidance
Other Intervention Name(s)
PCI with IVUS guidance group
Intervention Description
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
Intervention Type
Procedure
Intervention Name(s)
PCI without IVUS guidance
Intervention Description
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
Primary Outcome Measure Information:
Title
Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance
Description
Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance
Time Frame
12 months after the index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20 years old or older Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia Non-emergent conditions Patients with signed informed consent Stent length ≥28 mm by angiography estimation Significant coronary artery stenosis (> 50% by visual estimate) considered for coronary revascularization with stent implantation Reference vessel diameter of 2.5 to 4.0 mm by operator assessment Exclusion Criteria: Acute ST elevation myocardial infarction within 48 hours Contraindication to anti-platelet agents & bleeding history within prior 3 months Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus or other -limus group Prior history of the following presentations Cerebral vascular accident (not including transient ischemic attack) Peripheral artery occlusive diseases Thromboembolic disease Stent thrombosis Age > 80 years old Severe hepatic dysfunction (3 times normal reference values) Significant renal dysfunction (Serum creatinine > 2.0 mg/dl) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis Cardiogenic shock LVEF < 40% Pregnant women or women with potential childbearing Life expectancy < 1 year Left main disease requiring PCI Bifurcation lesion with 2-stent technique Chronic total occlusion Presence of previously implanted DES within 6-month In-stent restenosis lesion
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
35861828
Citation
Lee SY, Zhang JJ, Mintz GS, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Kan J, Pan T, Gao X, Ge Z, Chen SL, Hong MK. Procedural Characteristics of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention and Their Clinical Implications. J Am Heart Assoc. 2022 Jul 19;11(14):e025258. doi: 10.1161/JAHA.122.025258. Epub 2022 Jul 15.
Results Reference
derived
PubMed Identifier
32588238
Citation
Jang JY, Jung HW, Lee BK, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Kwon HM, Jang Y. Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation. Cardiovasc Drugs Ther. 2021 Apr;35(2):343-352. doi: 10.1007/s10557-020-07008-7.
Results Reference
derived
PubMed Identifier
30475845
Citation
Jang JY, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Jang Y. Optimal duration of DAPT after second-generation drug-eluting stent in acute coronary syndrome. PLoS One. 2018 Nov 26;13(11):e0207386. doi: 10.1371/journal.pone.0207386. eCollection 2018.
Results Reference
derived
PubMed Identifier
27212028
Citation
Hong SJ, Shin DH, Kim JS, Kim BK, Ko YG, Choi D, Her AY, Kim YH, Jang Y, Hong MK; IVUS-XPL Investigators. 6-Month Versus 12-Month Dual-Antiplatelet Therapy Following Long Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial. JACC Cardiovasc Interv. 2016 Jul 25;9(14):1438-46. doi: 10.1016/j.jcin.2016.04.036. Epub 2016 May 17.
Results Reference
derived
PubMed Identifier
26556051
Citation
Hong SJ, Kim BK, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Kang TS, Kang WC, Her AY, Kim YH, Hur SH, Hong BK, Kwon H, Jang Y, Hong MK; IVUS-XPL Investigators. Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2155-63. doi: 10.1001/jama.2015.15454. Erratum In: JAMA. 2016 Feb 2;315(5):518. Kim, Yonghoon [corrected to Kim, Yong Hoon].
Results Reference
derived

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Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)

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