Coronary Stenosis Clinical Trial
— IRIS-ROTAOfficial title:
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Verified date | December 2023 |
Source | Asan Medical Center |
Contact | Seung-jung Park, MD |
sjpark[@]amc.seoul.kr | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2028 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Patients = 19 years old - Patients who received rotational atherectomy - The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site. Exclusion Criteria: - Life expectancy <1y |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Soon Chun Hyang University Hospital Bucheon | Bucheon | |
Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
Korea, Republic of | Chungnam National University Hospital | Daejeon | |
Korea, Republic of | The Catholic University of Korea, Daejeon ST. Mary's Hospital | Daejeon | |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Inje University Pusan Paik Hospital | Pusan | |
Korea, Republic of | Bundang CHA Hospital | Seongnam | |
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seung-Jung Park | CardioVascular Research Foundation, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target vessel failure (TVF) | Target vessel failure (TVF) composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target Vessel Revascularization (TVR) at 12 months after the procedure. | 1 year | |
Secondary | All death | 1-,6-, and 12-months, and 3-,5-years | ||
Secondary | Cardiac death | 1-,6-, and 12-months, and 3-,5-years | ||
Secondary | Myocardial infarction | 1-,6-, and 12-months, and 3-,5-years | ||
Secondary | Composite of death or myocardial infarction | 1-,6-, and 12-months, and 3-,5-years | ||
Secondary | Composite of cardiac death or myocardial infarction | 1-,6-, and 12-months, and 3-,5-years | ||
Secondary | Target-lesion revascularization (TLR) | 1-,6-, and 12-months, and 3-,5-years | ||
Secondary | Target-vessel revascularization (TVR) | 1-,6-, and 12-months, and 3-,5-years | ||
Secondary | Stent thrombosis | according to Academic Research Consortium (ARC) criteria | 1-,6-, and 12-months, and 3-,5-years | |
Secondary | Stroke | 1-,6-, and 12-months, and 3-,5-years | ||
Secondary | Procedural success | Post-procedural diameter stenosis < 30% without death, Q-wave myocardial infarction, or urgent revascularization during the index admission | 7 days |
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