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

NCT02845804 | Unknown DMC

• 1 other identifier: HOST-ALPINE
• Study Type: observational
• Target: 1,533
• Locations: 1 country
• Sites: 20

Brief Summary

The objectives of this study are

1. 1.To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent
2. 2.To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent
3. 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

Conditions

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

Keywords

coronary artery disease; percutaneous coronary intervention; everolimus-eluting stents

Outcome Measures

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)

  12 months

Secondary Outcomes (7)

• Target vessel failure

  12 months

• Composite rate of cardiac death and myocardial infarction

  12 months, 3 years

• Composite rate of all-cause death and any myocardial infarction

  12 months, 3 years

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

  12 months, 3 years

• Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy

  12 months, 3 years

Study Arms (1)

Alpine

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

Device: Alpine

Interventions

Alpine DEVICE

Also known as: Everolimus-eluting stent

Alpine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Abbott: collaborator

Study Sites (20)

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

RECRUITING

Sejong General Hospital

Bucheon-si, Gyeonggi-do, South Korea

RECRUITING

Hallym University Sacred Heart Hospital

Anyang, South Korea

RECRUITING

Busan Paik Hospital

Busan, South Korea

RECRUITING

Kosin University Gospel Hospital

Busan, South Korea

RECRUITING

Dankook University Hospital

Cheonan, South Korea

RECRUITING

SoonChunHyang University Cheonan Hospital

Cheonan, South Korea

RECRUITING

Yongnam University Medical Center

Daegu, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Wonkwang University Hospital

Iksan, South Korea

RECRUITING

Inha University Hospital

Inchon, South Korea

RECRUITING

Chungbuk National University Hospital

Jeonju, South Korea

RECRUITING

Presbyterian Medical Center

Jeonju, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

Gangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

Hanyang University Medical Center

Seoul, South Korea

RECRUITING

Kangdong Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Seoul Boramae Hospital

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyo-soo Kim, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Hyo-soo Kim, MD, PhD

CONTACT

+82-2-2072-2226; hyosoo@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2021
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

KR (20)