IRISUltimaster: IRIS Ultimaster Cohort in the IRIS-DES Registry

• Sponsor: Duk-Woo Park, MD (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02719106
• Collaborator: CardioVascular Research Foundation, Korea (Other)
• Enrollment: 1,000
• Locations: 17
• Anticipated Duration (Months): 96.1
• Patients Per Site: 58.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the relative effectiveness and safety of Ultimaster stent compared to other drug eluting stents.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Ultimaster stent

Study Design

• Study Type: Observational
• Actual Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Effectiveness and Safety of Ultimaster® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
• Actual Study Start Date: Jul 20, 2016
• Actual Primary Completion Date: Jul 24, 2020
• Anticipated Study Completion Date: Jul 24, 2024

Arms and Interventions

Arm	Intervention/Treatment
Ultimaster stent	Device: Ultimaster stent

Outcome Measures

Primary Outcome Measures

1. Composite event [1year]

   The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

Secondary Outcome Measures

1. All death [5years]

2. Cardiac death [5years]

3. Myocardial infarction [5years]

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

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

6. Target Vessel revascularization [5years]

   Defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve). Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 %

7. Target Lesion revascularization [5years]

   Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

8. Stent thrombosis [5years]

   DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: >24 hours to 30 days post; late stent thrombosis: >30 days to 1 year post; Very late stent thrombosis: >1 year post;

9. Stroke [5years]

10. Procedural success [3days]

    Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death

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 Ultimaster stent

• Agreed with written informed consent form

Exclusion Criteria:

• Intervention with Ultimaster 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	Sejong General hospital	Bucheon		Korea, Republic of
2	Dong-A Medical Center	Busan		Korea, Republic of
3	Gangwon National Univ. Hospital	Chuncheon		Korea, Republic of
4	Daegu Catholic University Medical Center	Daegu		Korea, Republic of
5	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
6	Gangneung Asan Hospital	Gangneung		Korea, Republic of
7	Inje University Ilsan Paik Hospital	Ilsan		Korea, Republic of
8	Inha University Hospital	Incheon		Korea, Republic of
9	Kwangju Christian Hospital	Kwangju		Korea, Republic of
10	Pusan National University Hospital	Pusan		Korea, Republic of
11	Asan Medical Center	Seoul		Korea, Republic of
12	The Catholic Univ. of Korea Seoul St. Mary's hospital	Seoul		Korea, Republic of
13	The Catholic University of Korea St. Paul's Hospital	Seoul		Korea, Republic of
14	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul		Korea, Republic of
15	The Catholic University of Korea St. Vincent's Hospital	Suwon		Korea, Republic of
16	Ulsan University Hospital	Ulsan		Korea, Republic of
17	Wonju Severance Christian Hospital	Wonju		Korea, Republic of

Sponsors and Collaborators

• Duk-Woo Park, MD
• CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duk-Woo Park, MD, Sponsor-investigator, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT02719106
• Other Study ID Numbers: AMCCV2016-05
• First Posted: Mar 25, 2016
• 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 Duk-Woo Park, MD, Sponsor-investigator, Asan Medical Center: real world data; percutaneous coronary intervention; drug eluting stent
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Sep 13, 2021