Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice

Coronary Stenosis Clinical Trial

— IRIS-ROTA  

Official title:

Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03427996
• Other study ID #: AMCCV2018-02
• Status: Recruiting
• Start date: September 4, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Seung-jung Park, MD
• Email: sjpark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis, Coronary
• Coronary Artery Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Procedure:
• Rotational atherectomy
Percutaneous coronary intervention with rotational atherectomy

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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