Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis (HOST-ALPINE)

July 26, 2016 updated by: Hyo-Soo Kim, Seoul National University Hospital

Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions- Registry-based Study on the Effect and Safety of Xience Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Alpine Registry

The objectives of this study are

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Secondary endpoints of this study are

Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI

Target vessl failure

Composite rate of cardiac death and any MI, 3 years

Composite rate of all death and any MI

Composite rate of all death, any MI, and any repeat revascularization

Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy

Study Type

Observational

Enrollment (Anticipated)

1533

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
          • Sang-Ho Jo, MD,PhD
        • Principal Investigator:
          • Sang-Ho Jo, MD,PhD
      • Busan, Korea, Republic of
        • Recruiting
        • Busan Paik Hospital
        • Contact:
          • Tae-Hyun Yang
      • Busan, Korea, Republic of
        • Recruiting
        • Kosin University Gospel Hospital
      • Cheonan, Korea, Republic of
        • Recruiting
        • Dankook University Hospital
        • Contact:
          • Byung-Eun Park, MD,PhD
        • Principal Investigator:
          • Byung-Eun Park, MD,PhD
      • Cheonan, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Cheonan Hospital
        • Contact:
          • Sang-Ho Park
        • Principal Investigator:
          • Sang-Ho Park
      • Chongju, Korea, Republic of
        • Recruiting
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of
        • Recruiting
        • Yongnam University Medical Center
        • Contact:
        • Principal Investigator:
          • Jong-Sun Park, MD,PhD
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
          • Myung-Ho Jeong
      • Iksan, Korea, Republic of
        • Recruiting
        • Wonkwang University Hospital
        • Contact:
        • Principal Investigator:
          • Seok-Kyo Oh, MD,PhD
      • Inchon, Korea, Republic of
        • Recruiting
        • Inha University Hospital
        • Contact:
        • Principal Investigator:
          • Seong-Il Woo, MD,PhD
      • Jeonju, Korea, Republic of
        • Recruiting
        • Presbyterian Medical Center
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • In-Ho Chae, MD,PhD
        • Principal Investigator:
          • In-Ho Chae, MD,PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Boramae Hospital
        • Contact:
        • Principal Investigator:
          • Sang-Hyun Kim, MD,PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangdong Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Kyoo-Rok Han, MD,PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangbuk Samsung Hospital
        • Contact:
          • Ki-Cheol Sung, MD,PhD
        • Principal Investigator:
          • Ki-Cheol Sung, MD,PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Medical Center
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of
        • Recruiting
        • Kangwon National University Hospital
        • Contact:
          • Yong-Hoon Kim
        • Principal Investigator:
          • Yong-Hoon Kim
      • Wonju, Gangwon-do, Korea, Republic of
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:
          • Jung-Han Yoon
        • Principal Investigator:
          • Jung-Han Yoon
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Sejong General Hospital
        • Principal Investigator:
          • Young-Jin Choi
        • Contact:
          • Young-Jin Choi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All coronary arterial disease patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent(s)

Description

Inclusion Criteria:

  • The patient agrees to participate in this study by signing the informed consent form.

Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form

Exclusion Criteria:

  • There are no exclusion criteria for this registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alpine
The patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™
Device: Alpine
Other Names:
  • Everolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months
Composite rate of cardiac death and myocardial infarction
Time Frame: 12 months, 3 years
12 months, 3 years
Composite rate of all-cause death and any myocardial infarction
Time Frame: 12 months, 3 years
12 months, 3 years
Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization
Time Frame: 12 months, 3 years
12 months, 3 years
Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy
Time Frame: 12 months, 3 years
12 months, 3 years
Clinical device and procedural success rate
Time Frame: intraoperative
intraoperative
Stent thrombosis
Time Frame: within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year
acute (within 24 hours), subacute (1 - 30 days), late (31 days - 1 year), very late (>1 year)
within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

July 24, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOST-ALPINE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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