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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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