Coronary Artery DiseaseHOST-ALPINENCT02845804
Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Seoul National University Hospital at 20 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome
- What is being tested?
- Alpine
- Type of treatment
- Medical device
- How many people
- 1,533 participants
- Where
- 20 sitesSouth Korea
- Study dates
- Jul 2015to Jul 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All coronary arterial disease patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent(s)
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria for this registry.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites, 20 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang
Sang-Ho Jo, MD,PhD
Sang-Ho Jo, MD,PhD
- Recruiting
Sejong General Hospital
Bucheon-si, Gyeonggi-do
Young-Jin Choi
Young-Jin Choi
- Recruiting
Busan Paik Hospital
Busan
Tae-Hyun Yang
- Recruiting
Kosin University Gospel Hospital
Busan
Jeong Ho Heo
- Recruiting
Dankook University Hospital
Cheonan
Byung-Eun Park, MD,PhD
Byung-Eun Park, MD,PhD
- Recruiting
SoonChunHyang University Cheonan Hospital
Cheonan
Sang-Ho Park
Sang-Ho Park
- Recruiting
Kangwon National University Hospital
Chuncheon, Gangwon-do
Yong-Hoon Kim
Yong-Hoon Kim
- Recruiting
Yongnam University Medical Center
Daegu
Jong-Sun Park, MD,PhD, pjs@medical.yu.ac.kr
Jong-Sun Park, MD,PhD
- Recruiting
Chonnam National University Hospital
Gwangju
Myung-Ho Jeong
- Recruiting
Wonkwang University Hospital
Iksan
Seok-Kyo Oh, MD,PhD, oskcar@wonkwang.ac.kr
Seok-Kyo Oh, MD,PhD
- Recruiting
Inha University Hospital
Inchon
Seong-Il Woo, MD,PhD, wjswgs@naver.com
Seong-Il Woo, MD,PhD
- Recruiting
Chungbuk National University Hospital
Jeonju
Jang-Hwan Bae, MD,PhD, drcorazon@hanmail.net
Jang-Hwan Bae, MD,PhD
- Recruiting
Presbyterian Medical Center
Jeonju
Je-Young Rhew, MD,PhD, jkrhew@hanafos.com
Je-Young Rhew, MD,PhD
- Recruiting
Seoul National University Bundang Hospital
Seongnam
In-Ho Chae, MD,PhD
In-Ho Chae, MD,PhD
- Recruiting
Gangbuk Samsung Hospital
Seoul
Ki-Cheol Sung, MD,PhD
Ki-Cheol Sung, MD,PhD
- Recruiting
Hanyang University Medical Center
Seoul
Young-Hyo Lim
Young-Hyo Lim
- Recruiting
Kangdong Sacred Heart Hospital
Seoul
Kyoo-Rok Han, MD,PhD, krheart@hallym.or.kr
Kyoo-Rok Han, MD,PhD
- Recruiting
Seoul Boramae Hospital
Seoul
Sang-Hyun Kim, MD,PhD, shkimmd@snu.ac.kr
Sang-Hyun Kim, MD,PhD
- Recruiting
Seoul National University Hospital
Seoul
Hyo-soo Kim, MD, PhD, +82-2-2072-2223, hyosoo@snu.ac.kr
Hyo-soo Kim, MD, PhD
- Recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do
Jung-Han Yoon
Jung-Han Yoon
About this study
Official title: 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
- To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent
- To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent
- 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
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome, Angina Pectoris
- Being tested
- Alpine
- Keywords
- coronary artery disease, percutaneous coronary intervention, everolimus-eluting stents
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlpineDevice
Also called Everolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Alpine | The patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ Receives: Device: Alpine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
Measured: 12 months
Secondary outcomes (7)
Target vessel failure
Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
Measured: 12 months
Composite rate of cardiac death and myocardial infarction
Measured: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction
Measured: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization
Measured: 12 months, 3 years
Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy
Measured: 12 months, 3 years
Clinical device and procedural success rate
Measured: intraoperative
Stent thrombosis
acute (within 24 hours), subacute (1 - 30 days), late (31 days - 1 year), very late (>1 year)
Measured: within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,533 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
- Investigators
- Hyo-soo Kim, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845804
- Sponsor's protocol ID
- HOST-ALPINE
- Acronym
- HOST-ALPINE
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02845804
- Acronym / sponsor ID
- HOST-ALPINE / HOST-ALPINE
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome, Angina Pectoris
- Keywords
- coronary artery disease, percutaneous coronary intervention, everolimus-eluting stents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,533 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are
- To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent
- To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent
- 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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpine | – | Device: AlpineThe patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All coronary arterial disease patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent(s)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlpineAlso: Everolimus-eluting stent | Device | Alpine |
Primary outcome
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)
7 secondary outcomes
Target vessel failure
Time frame: 12 months
Composite rate of cardiac death and myocardial infarction
Time frame: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction
Time frame: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization
Time frame: 12 months, 3 years
Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy
Time frame: 12 months, 3 years
Clinical device and procedural success rate
Time frame: intraoperative
Stent thrombosis
Time frame: within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyo-soo Kim, MD, PhD study chair
Seoul National University Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Seoul National University Hospital at 20 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyo-soo Kim, MD, PhD (+82-2-2072-2226, hyosoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.