Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice (IRIS-ROTA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Stenosis; Atherosclerosis, Coronary
• Intervention / Treatment: Procedure: Rotational atherectomy

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jung-hee Ham, RN; Phone Number: 82230104728; Email: cvcrc5@amc.seoul.kr
• Study Contact Backup: Name: Seung-jung Park, MD; Email: sjpark@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Recruiting
    • Soon Chun Hyang University Hospital Bucheon
    • Contact: Nae-Hee Lee, MD
    • Principal Investigator: Nae-Hee Lee, MD
  • Daegu, Korea, Republic of
    • Recruiting
    • Daegu Catholic University Medical Center
    • Contact: Kee-Sik Kim, MD
    • Principal Investigator: Kee-Sik Kim, MD
  • Daejeon, Korea, Republic of
    • Terminated
    • Chungnam National University Hospital
  • Daejeon, Korea, Republic of
    • Withdrawn
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Gwangju, Korea, Republic of
    • Not yet recruiting
    • Chonnam National University Hospital
    • Contact: Young-jun Hong, MD
    • Principal Investigator: Young-jun Hong, MD
  • Pusan, Korea, Republic of
    • Active, not recruiting
    • Inje University Pusan Paik Hospital
  • Seongnam, Korea, Republic of
    • Terminated
    • Bundang CHA Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Seung-jung Park, MD
    • Principal Investigator: Seung-jung Park, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive percutaneous coronary intervention patients receiving rotational atherectomy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary disease	Procedure: Rotational atherectomy; Percutaneous coronary intervention with rotational atherectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All death		1-,6-, and 12-months, and 3-,5-years
Cardiac death		1-,6-, and 12-months, and 3-,5-years
Myocardial infarction		1-,6-, and 12-months, and 3-,5-years
Composite of death or myocardial infarction		1-,6-, and 12-months, and 3-,5-years
Composite of cardiac death or myocardial infarction		1-,6-, and 12-months, and 3-,5-years
Target-lesion revascularization (TLR)		1-,6-, and 12-months, and 3-,5-years
Target-vessel revascularization (TVR)		1-,6-, and 12-months, and 3-,5-years
Stent thrombosis	according to Academic Research Consortium (ARC) criteria	1-,6-, and 12-months, and 3-,5-years
Stroke		1-,6-, and 12-months, and 3-,5-years
Procedural success	Post-procedural diameter stenosis < 30% without death, Q-wave myocardial infarction, or urgent revascularization during the index admission	7 days

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: rotational atherectomy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Coronary Stenosis
• Other Study ID Numbers: AMCCV2018-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No