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Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis (HOST-ONYX)

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ClinicalTrials.gov Identifier: NCT03151018
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital

Brief Summary:

The objectives of this study are

  1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent.
  2. To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent.
  3. To compare the long-term efficacy and safety of coronary stenting between the Resolute Onyx™ stent and other contemporary drug-eluting stents which had established their own registry.

Condition or disease Intervention/treatment
Coronary Artery Disease Acute Coronary Syndrome Myocardial Infarction Angina Pectoris Device: Resolute Onyx

Detailed Description:

Secondary endpoints are

  1. Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI (percutaneous coronary intervention),
  2. Target vessel failure
  3. Composite rate of cardiac death and any MI, 3 years
  4. Composite rate of all death and any MI
  5. Composite rate of all death, any MI, and any repeat revascularization
  6. Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
  7. Clinical device and procedural success

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions - Registry-based Study on the Effect and Safety of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Onyx Registry
Study Start Date : May 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2021

Group/Cohort Intervention/treatment
Onyx
The patients who received PCI with Resolute Onyx stent(s)
Device: Resolute Onyx
Other Name: Zotarolimus-eluting stent




Primary Outcome Measures :
  1. Target lesion failure [ Time Frame: 12 months ]
    Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)


Secondary Outcome Measures :
  1. Stent thrombosis, acute [ Time Frame: within 24 hours after index PCI ]
    according to Academic Research Consortium (ARC) definition

  2. Stent thrombosis, subacute [ Time Frame: from 24 hours to 30 days after index PCI ]
    according to ARC definition

  3. Stent thrombosis, late [ Time Frame: from 30 days to 1 year after index PCI ]
    according to ARC definition

  4. Stent thrombosis, very-late [ Time Frame: 1 year ~ up to 3 years ]
    according to ARC definition

  5. Target vessel failure [ Time Frame: 12 months ]
    Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)

  6. Composite rate of cardiac death and myocardial infarction [ Time Frame: 12 months, 3 years ]
    as title

  7. Composite rate of all-cause death and any myocardial infarction [ Time Frame: 12 months, 3 years ]
    as title

  8. Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization [ Time Frame: 12 months, 3 years ]
    as title

  9. Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: 12 months, 3 years ]
    we will estimate this outcome with relevant questionnaire

  10. Clinical device and procedural success rate [ Time Frame: intraoperative ( index PCI) ]
    device success : residual stenosis <30%, final thrombolysis in myocardial infarction (TIMI) flow grade III procedural success : device success + no adverse events immediate after the procedure



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All coronary arterial disease patients who received percutaneous coronary intervention with Resolute Onyx™ stent(s)
Criteria

Inclusion Criteria:

  • Age above 19
  • Patients who received PCI with Resolute Onyx™ stent(s)

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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): NCT03151018


Contacts
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Contact: Hyo-soo Kim, MD, PhD +82-2-2072-2226 hyosoo@snu.ac.kr

Locations
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Korea, Republic of
Kosin University Gospel Hospital Recruiting
Busan, Korea, Republic of
Contact: Jeong Ho Heo         
Soon Chun Hyang University Hospital Cheonan Recruiting
Cheonan, Korea, Republic of
Contact: Dong-Kyo Jin, MD,PhD       bluesky@schch.co.kr   
Principal Investigator: Dong-Kyu Jin, MD,PhD         
Chungbuk National University Hospital Recruiting
Chonju, Korea, Republic of
Contact: Jang-Hwan Bae, MD,PhD       drcorazon@hanmail.net   
Principal Investigator: Jang-Hwan Bae, MD,PhD         
Myongji Hospital Recruiting
Goyang, Korea, Republic of
Contact: Deok-Kyu Cho         
Gwangju Christian Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Seung Uk Lee         
Kwangju Veterans Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Won Kim, MD,PhD       mylovekw@hanmail.net   
Principal Investigator: Won Kim, MD,PhD         
Presbyterian Medical Center Recruiting
Jeonju, Korea, Republic of
Contact: Je-Young Rhew, MD,PhD       jkrhew@hanafos.com   
Principal Investigator: Je-Young Rhew, MD,PhD         
Gyeongsang National University Hospital Recruiting
Jinju, Korea, Republic of
Contact: Choong-Hwan Cwak, MD,PhD       cwakch@korea.com   
Principal Investigator: Choong-Hwan Cwak, MD,PhD         
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Contact: Han-Cheol Lee, MD,PhD       glaraone@hanmail.net   
Principal Investigator: Han-Cheol Lee, MD,PhD         
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of
Contact: Dong-Ju Choi, MD,PhD       djchoi@snu.ac.kr   
Principal Investigator: Dong-Ju Choi, MD,PhD         
Gangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jin-Ho Kang, MD,PhD       jinho2.kang@samsung.com   
Principal Investigator: Jin-Ho Kang, MD,PhD         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyuk-Moon Kwon, MD,PhD       kwonhm@yuhs.ac   
Principal Investigator: Hyuk-Moon Kwon, MD,PhD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hyun-Cheol Kwon, MD,PhD       hcgwon@skku.edu   
Principal Investigator: Hyun-Cheol Kwon, MD,PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyo-Soo Kim, MD, PhD    82-2-2072-2226    hyosoo@snu.ac.kr   
Principal Investigator: Hyo-soo Kim, MD, PhD         
Sub-Investigator: Bon-Kwon Koo, MD, PhD         
Sub-Investigator: Hyun-Jae Kang, MD, PhD         
Sub-Investigator: Hae-Young Lee, MD, PhD         
Sub-Investigator: Hyun-Jae Cho, MD, PhD         
Sub-Investigator: Kyung-Woo Park, MD, PhD         
Sub-Investigator: Han-Mo Yang, MD, PhD         
Sub-Investigator: Jung-Kyu Han, MD, PhD         
Sub-Investigator: Sang-Eun Lee, MD, PhD         
Soonchunhyang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Min-Soo Hyon, MD,PhD       mshyon@hosp.sch.ac.kr   
Principal Investigator: Min-Soo Hyon, MD,PhD         
St. Vincent's Hospital Recruiting
Suwon, Korea, Republic of
Contact: Geon-Woong Moon, MD,PhD       cardiomoon@gmail.com   
Principal Investigator: Geon-Woong Moon, MD,PhD         
Sponsors and Collaborators
Seoul National University Hospital
Medtronic
Investigators
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Study Chair: Hyo-soo Kim, MD, PhD Seoul National University Hospital

Additional Information:

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Responsible Party: Hyo-Soo Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03151018     History of Changes
Other Study ID Numbers: HOST-ONYX
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

Keywords provided by Hyo-Soo Kim, Seoul National University Hospital:
coronary artery disease
percutaneous coronary intervention
zotarolimus-eluting stents

Additional relevant MeSH terms:
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Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs