IRIS Sierra: Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice

• Sponsor: Seung-Jung Park (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03967158
• Collaborator: CardioVascular Research Foundation, Korea (Other)
• Enrollment: 2,000
• Locations: 12
• Anticipated Duration (Months): 96.3
• Patients Per Site: 166.7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Disease	Device: Xience Sierra stent

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY
• Actual Study Start Date: Dec 23, 2019
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Consecutive percutaneous coronary intervention	Device: Xience Sierra stent; Percutaneous coronary intervention with Xience Sierra stent

Outcome Measures

Primary Outcome Measures

1. Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) [1 year]

Secondary Outcome Measures

1. All cause death [5 year]

2. Cardiac death [5 year]

3. Myocardial Infarction [5 year]

4. Composite event rate of death or myocardial infarction (MI) [5 year]

5. Composite event rate of cardiac death or myocardial infarction (MI) [5 year]

6. Target- Vessel Revascularization [5 year]

7. Target- Lesion Revascularization [5 year]

8. Stent thrombosis [5 year]

9. Stroke [5 year]

10. Procedural Success rate [5 year]

    Procedural success rate is defined as < 30 % final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization.

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

• Patient with Xience Sierra Everolimus eluting coronary stent

Exclusion Criteria:

• Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time

• Life-expectancy less than 1 year

• Cardiac shock

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dong-A Medical Center	Busan		Korea, Republic of
2	Inje University Busan Paik Hospital	Busan		Korea, Republic of
3	Gangwon National Univ. Hospital	Chuncheon		Korea, Republic of
4	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
5	Gangneung Asan Hospital	Gangneung		Korea, Republic of
6	ChonBuk National University Hospital	Jeonju		Korea, Republic of
7	Asan Medical Center	Seoul		Korea, Republic of
8	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul		Korea, Republic of
9	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul		Korea, Republic of
10	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul		Korea, Republic of
11	St.carollo Hospital	Suncheon		Korea, Republic of
12	Wonju Severance Christian Hospital	Wonju		Korea, Republic of

Sponsors and Collaborators

• Seung-Jung Park
• CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Jung Park, Professor, Division of Interventional Cardiology. Cardiovascular Center, Asan Medical Center. University of Ulsan, College of Medicine, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03967158
• Other Study ID Numbers: AMCCV2019-03
• First Posted: May 30, 2019
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seung-Jung Park, Professor, Division of Interventional Cardiology. Cardiovascular Center, Asan Medical Center. University of Ulsan, College of Medicine, Asan Medical Center: Xience Sierra; Drug Eluting Stent; Percutaneous coronary intervention
• Additional relevant MeSH terms: Coronary Artery Disease; Coronary Disease

Study Results

No Results Posted as of Sep 13, 2021