IRIS XPEDITION: XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice

• Sponsor: Seung-Jung Park (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02042300
• Collaborator: CardioVascular Research Foundation, Korea (Other), Abbott (Industry)
• Enrollment: 4,000
• Locations: 26
• Anticipated Duration (Months): 122
• Patients Per Site: 153.8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate effectiveness and safety of XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Transluminal Coronary Angioplasty; Coronary Artery Disease	Device: XIENCE Xpedition/Alpine/Sierra

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Effectiveness and Safety of XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jul 1, 2020
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
IRIS-Xpedition/Alpine/Sierra Cohort XIENCE Xpedition/Alpine/Sierra	Device: XIENCE Xpedition/Alpine/Sierra

Outcome Measures

Primary Outcome Measures

1. Composite event rate [1year]

   Death, non fatal myocardial infarction, Target Vessel Revascularization

Secondary Outcome Measures

1. All death [5year]

2. Cardiac death [5year]

3. Myocardial infarction [5year]

4. Composite event of death or myocardial infarction [5year]

5. Composite event of cardiac death or myocardial infarction [5year]

6. Target Vessel revascularization [5year]

7. Target lesion revascularization [5year]

8. Stent thrombosis by an Academic Research Consortium (ARC) criteria [5year]

9. Stroke [5year]

10. procedural success [3day]

    defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization participants will be followed for the duration of hospital stay, an expected average of 3days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 19 and more

• Intervention with XIENCE Xpedition or Alpine or Sierra everolimus eluting coronary stent

• Agreed with written informed consent form

Exclusion Criteria:

• Intervention with XIENCE Xpedition or Alpine or Sierra everolimus eluting coronary stent and other drug eluting stent at the same time

• Life expectancy of 1year and under

• Cardiac shock

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hallym University Sacred Heart Hospital	Anyang		Korea, Republic of
2	Soon Chun Hyang University Hospital Bucheon	Bucheon		Korea, Republic of
3	Soon Chun Hyang University Hospital Cheonan	Cheonan		Korea, Republic of
4	Gangwon National Univ. Hospital	Chuncheon		Korea, Republic of
5	Daegu Catholic University Medical Center	Daegu		Korea, Republic of
6	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
7	Yeungnam University Medical Center	Daegu		Korea, Republic of
8	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon		Korea, Republic of
9	Gangneung Asan Hospital	Gangneung		Korea, Republic of
10	Chonnam National University Hospital	Gwangju		Korea, Republic of
11	Gachon University Gil Hospital	Incheon		Korea, Republic of
12	Inha University Hospital	Incheon		Korea, Republic of
13	ChonBuk National University Hospital	Jeonju		Korea, Republic of
14	Kwangju Christian Hospital	Kwangju		Korea, Republic of
15	Dong-A Medical Center	Pusan		Korea, Republic of
16	Inje University HAEUNDAE Paik Hospital	Pusan		Korea, Republic of
17	Inje University Pusan Paik Hospital	Pusan		Korea, Republic of
18	Pusan National University Hospital	Pusan		Korea, Republic of
19	Asan Medical Center	Seoul		Korea, Republic of
20	Korea University Guro Hospital	Seoul		Korea, Republic of
21	Seoul Veterans Hospital	Seoul		Korea, Republic of
22	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul		Korea, Republic of
23	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul		Korea, Republic of
24	The Catholic University of Korea Uijeongbu St. Mary's Hospital	Uijeongbu		Korea, Republic of
25	Ulsan University Hospital	Ulsan		Korea, Republic of
26	Pusan National University Yangsan Hospital	Yangsan		Korea, Republic of

Sponsors and Collaborators

• Seung-Jung Park
• CardioVascular Research Foundation, Korea
• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Jung Park, MD,PhD, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT02042300
• Other Study ID Numbers: AMCCV2013-11
• First Posted: Jan 22, 2014
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Seung-Jung Park, MD,PhD, Asan Medical Center: XIENCE Xpedition; Routine Clinical Practice; Alpine; Sierra
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Sep 13, 2021