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Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions

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ClinicalTrials.gov Identifier: NCT05200637
Recruitment Status : Not yet recruiting
First Posted : January 21, 2022
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Ying-Chang Tung, Chang Gung Memorial Hospital

Study Description
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Brief Summary:
This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting stent (Xience, Abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. How the differences in stent platforms affect vessel healing process will be examined by optical coherence tomography.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Orsiro stent Device: Xience stent Device: Any drug-eluting stent Not Applicable

Detailed Description:
Patients with true coronary bifurcation lesions (Medina [1, 1, 1] or [0, 1, 1]) will be enrolled and randomized to undergo two-stent double kissing crush technique with Orsiro or Xience. Pre-intervention and post-stenting optical coherence tomography will be performed during the index procedure. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy. All subjects will receive coronary angiography and optical coherence tomography follow-up at 3 and 12 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with true coronary bifurcation lesions will be randomized to undergo two-stent DK-crush technique with Orsiro or Xience. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel, Active Controlled Study to Evaluate the Vascular Response of Orsiro vs. Xience Drug Eluting Stent System in Subjects With Coronary Bifurcation Lesions
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

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MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Orsiro
Two-stent DK-crush technique with Orsiro
 Device: Orsiro stent
Orsiro stent
Active Comparator: Xience
Two-stent DK-crush technique with Xience
 Device: Xience stent
Xience stent
Single stent
Provisional one-stent strategy with any drug-eluting stent
 Device: Any drug-eluting stent
Any drug-eluting stent


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of stent strut coverage at bifurcation segments [ Time Frame: 3 months post-procedure ]

Secondary Outcome Measures :
  1. Neointimal thickness (μm) at bifurcation segments [ Time Frame: 3 months post-procedure ]
  2. Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments [ Time Frame: 3 months post-procedure ]
  3. Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments [ Time Frame: 3 months post-procedure ]
  4. Percentage of acquired malapposed struts at bifurcation segments [ Time Frame: 3 months post-procedure ]
  5. Percentage of stent strut coverage at bifurcation segments [ Time Frame: 12 months post-procedure ]
  6. Neointimal thickness (μm) at bifurcation segments [ Time Frame: 12 months post-procedure ]
  7. Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments [ Time Frame: 12 months post-procedure ]
  8. Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments [ Time Frame: 12 months post-procedure ]
  9. Percentage of acquired malapposed struts at bifurcation segments [ Time Frame: 12 months post-procedure ]
  10. In-stent late-lumen loss by quantitative coronary analysis [ Time Frame: 3 months post-procedure ]
  11. In-segment late lumen loss by quantitative coronary analysis [ Time Frame: 3 months post-procedure ]
  12. Target Lesion Revascularization (TLR) [ Time Frame: 3 months post-procedure ]
  13. Target Vessel Revascularization (TVR) [ Time Frame: 3 months post-procedure ]
  14. Target Lesion Failure (TLF) [ Time Frame: 3 months post-procedure ]
    Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR

  15. Major Cardiac Adverse Events (MACE) [ Time Frame: 3 months post-procedure ]
    Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR)

  16. Instent late-lumen loss by quantitative coronary analysis [ Time Frame: 12 months post-procedure ]
  17. In-segment late lumen loss by quantitative coronary analysis [ Time Frame: 12 months post-procedure ]
  18. Target Lesion Revascularization (TLR) [ Time Frame: 12 months post-procedure ]
  19. Target Vessel Revascularization (TVR) [ Time Frame: 12 months post-procedure ]
  20. Target Lesion Failure (TLF) [ Time Frame: 12 months post-procedure ]
    Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR

  21. Major Cardiac Adverse Events (MACE) [ Time Frame: 12 months post-procedure ]
    Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR)

  22. Stent thrombosis [ Time Frame: 1 months post-procedure ]
    Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis

  23. Stent thrombosis [ Time Frame: 3 months post-procedure ]
    Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis

  24. Stent thrombosis [ Time Frame: 12 months post-procedure ]
    Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are at least 20 years old and present with acute or chronic coronary syndrome.
  2. Patients who are suitable for PCI with DES implantation and provide written informed consent.
  3. Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique.
  4. Target vessels suitable for OCT examination.
  5. Women of childbearing potential must have a negative pregnancy (serum and/or urine) test within 7 days prior to index procedure in accordance with the institutional standard of care. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.

Exclusion Criteria:

  1. Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT)
  2. Estimated glomerular filtration rate < 45 ml/min/1.73 m2
  3. Liver cirrhosis
  4. Life expectancy < 1 year
  5. Planned surgery within 3 months
  6. Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months
  7. Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05200637


Contacts
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Contact: Ying-Chang Tung, MD 886-3-3281200 ext 8162 n12374@cgmh.org.tw
Contact: Chi-Jen Chang, MD 886-3-3281200 ext 8162 chijenformosa@gmail.com

Locations
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Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Ying-Chang Tung, MD Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
Study Chair: Chi-Jen Chang, MD Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
Study Director: Chia-Pin Lin, MD Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
More Information
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Responsible Party: Ying-Chang Tung, Assistant Professor, Department of Cardiology, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT05200637    
Other Study ID Numbers: 202101599A3
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ying-Chang Tung, Chang Gung Memorial Hospital:
Drug-eluting stents
Coronary bifurcation lesions
Double-kissing crush technique
Optical coherence tomography
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases