CClinicalTrials.gg
Status unknownNCT02845804HOST-ALPINEUpdated Jul 27, 2016

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

An observational study in Coronary Artery Disease, Percutaneous Coronary Intervention and Acute Coronary Syndrome, sponsored by Seoul National University Hospital. Status unknown at 20 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-07-27.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,533
Ages
19 Years and older
Sex
All
01

Study summary

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
Read the 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

02

Conditions studied

  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
  • Acute Coronary Syndrome
  • Angina Pectoris

Keywords

  • coronary artery disease
  • percutaneous coronary intervention
  • everolimus-eluting stents
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 1,533 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • There are no exclusion criteria for this registry.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,533 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Alpine

    The patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™

    Device: Alpine

Interventions

  • DeviceAlpine

    Also known as: Everolimus-eluting stent

06

What researchers measure

Primary outcomes

  1. Target lesion failure

    Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)

    Time frame: 12 months

Secondary outcomes

  1. Target vessel failure

    Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)

    Time frame: 12 months

  2. Composite rate of cardiac death and myocardial infarction

    Time frame: 12 months, 3 years

  3. Composite rate of all-cause death and any myocardial infarction

    Time frame: 12 months, 3 years

  4. Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization

    Time frame: 12 months, 3 years

  5. Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy

    Time frame: 12 months, 3 years

  6. Clinical device and procedural success rate

    Time frame: intraoperative

  7. Stent thrombosis

    acute (within 24 hours), subacute (1 - 30 days), late (31 days - 1 year), very late (\>1 year)

    Time frame: within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year

07

Study locations

20 of 20 sites recruiting
  • Kangwon National University Hospital
    Chuncheon, Gangwon-do, Korea, Republic of
    • Yong-Hoon Kim · Contact
    • Yong-Hoon Kim · Principal investigator
    Recruiting
  • Wonju Severance Christian Hospital
    Wonju, Gangwon-do, Korea, Republic of
    • Jung-Han Yoon · Contact
    • Jung-Han Yoon · Principal investigator
    Recruiting
  • Sejong General Hospital
    Bucheon, Gyeonggi-do, Korea, Republic of
    • Young-Jin Choi · Contact
    • Young-Jin Choi · Principal investigator
    Recruiting
  • Hallym University Sacred Heart Hospital
    Anyang, Korea, Republic of
    • Sang-Ho Jo, MD,PhD · Contact
    • Sang-Ho Jo, MD,PhD · Principal investigator
    Recruiting
  • Busan Paik Hospital
    Busan, Korea, Republic of
    • Tae-Hyun Yang · Contact
    Recruiting
  • Kosin University Gospel Hospital
    Busan, Korea, Republic of
    • Jeong Ho Heo · Contact
    Recruiting
  • Dankook University Hospital
    Cheonan, Korea, Republic of
    • Byung-Eun Park, MD,PhD · Contact
    • Byung-Eun Park, MD,PhD · Principal investigator
    Recruiting
  • SoonChunHyang University Cheonan Hospital
    Cheonan, Korea, Republic of
    • Sang-Ho Park · Contact
    • Sang-Ho Park · Principal investigator
    Recruiting
  • Chungbuk National University Hospital
    Chongju, Korea, Republic of
    Recruiting
  • Yongnam University Medical Center
    Daegu, Korea, Republic of
    • Jong-Sun Park, MD,PhD · Contact · pjs@medical.yu.ac.kr
    • Jong-Sun Park, MD,PhD · Principal investigator
    Recruiting
  • Chonnam National University Hospital
    Gwangju, Korea, Republic of
    • Myung-Ho Jeong · Contact
    Recruiting
  • Wonkwang University Hospital
    Iksan, Korea, Republic of
    Recruiting
  • Inha University Hospital
    Inchon, Korea, Republic of
    • Seong-Il Woo, MD,PhD · Contact · wjswgs@naver.com
    • Seong-Il Woo, MD,PhD · Principal investigator
    Recruiting
  • Presbyterian Medical Center
    Jeonju, Korea, Republic of
    • Je-Young Rhew, MD,PhD · Contact · jkrhew@hanafos.com
    • Je-Young Rhew, MD,PhD · Principal investigator
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam, Korea, Republic of
    • In-Ho Chae, MD,PhD · Contact
    • In-Ho Chae, MD,PhD · Principal investigator
    Recruiting
  • Gangbuk Samsung Hospital
    Seoul, Korea, Republic of
    • Ki-Cheol Sung, MD,PhD · Contact
    • Ki-Cheol Sung, MD,PhD · Principal investigator
    Recruiting
  • Hanyang University Medical Center
    Seoul, Korea, Republic of
    • Young-Hyo Lim · Contact
    • Young-Hyo Lim · Principal investigator
    Recruiting
  • Kangdong Sacred Heart Hospital
    Seoul, Korea, Republic of
    • Kyoo-Rok Han, MD,PhD · Contact · krheart@hallym.or.kr
    • Kyoo-Rok Han, MD,PhD · Principal investigator
    Recruiting
  • Seoul Boramae Hospital
    Seoul, Korea, Republic of
    • Sang-Hyun Kim, MD,PhD · Contact · shkimmd@snu.ac.kr
    • Sang-Hyun Kim, MD,PhD · Principal investigator
    Recruiting
  • Seoul National University Hospital
    Seoul, Korea, Republic of
    • Hyo-soo Kim, MD, PhD · Contact · hyosoo@snu.ac.kr · +82-2-2072-2223
    • Hyo-soo Kim, MD, PhD · Principal investigator
    • Bon-Kwon Koo, MD, PhD · Sub investigator
    • Hyun-Jae Kang, MD, PhD · Sub investigator
    • Jung-Kyu Han, MD, PhD · Sub investigator
    • Sang-Eun Lee, MD, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02845804
Lead sponsor
Seoul National University Hospital
Collaborators
Abbott
Responsible party
Hyo-Soo Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jul 27, 2016
Start date
Jul 2015
Primary completion
Jul 2018 (estimated)
Completion
Jul 2021 (estimated)
Last update
Jul 27, 2016

Study contacts

Hyo-soo Kim, MD, PhD
Contact
hyosoo@snu.ac.kr
+82-2-2072-2226
Hyo-soo Kim, MD, PhD
study chair · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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