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

• Sponsor: Seung-Jung Park (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03427996
• Collaborator: CardioVascular Research Foundation, Korea (Other)
• Enrollment: 500
• Locations: 8
• Anticipated Duration (Months): 111.9
• Patients Per Site: 62.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis, Coronary; Coronary Stenosis	Procedure: Rotational atherectomy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study
• Actual Study Start Date: Sep 4, 2018
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Target vessel failure (TVF) [1 year]

   Target vessel failure (TVF) composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target Vessel Revascularization (TVR) at 12 months after the procedure.

Secondary Outcome Measures

1. All death [1-,6-, and 12-months, and 3-,5-years]

2. Cardiac death [1-,6-, and 12-months, and 3-,5-years]

3. Myocardial infarction [1-,6-, and 12-months, and 3-,5-years]

4. Composite of death or myocardial infarction [1-,6-, and 12-months, and 3-,5-years]

5. Composite of cardiac death or myocardial infarction [1-,6-, and 12-months, and 3-,5-years]

6. Target-lesion revascularization (TLR) [1-,6-, and 12-months, and 3-,5-years]

7. Target-vessel revascularization (TVR) [1-,6-, and 12-months, and 3-,5-years]

8. Stent thrombosis [1-,6-, and 12-months, and 3-,5-years]

   according to Academic Research Consortium (ARC) criteria

9. Stroke [1-,6-, and 12-months, and 3-,5-years]

10. Procedural success [7 days]

    Post-procedural diameter stenosis < 30% without death, Q-wave myocardial infarction, or urgent revascularization during the index admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soon Chun Hyang University Hospital Bucheon	Bucheon		Korea, Republic of
2	Daegu Catholic University Medical Center	Daegu		Korea, Republic of
3	Chungnam National University Hospital	Daejeon		Korea, Republic of
4	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon		Korea, Republic of
5	Chonnam National University Hospital	Gwangju		Korea, Republic of
6	Inje University Pusan Paik Hospital	Pusan		Korea, Republic of
7	Bundang CHA Hospital	Seongnam		Korea, Republic of
8	Asan Medical Center	Seoul		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 Cardiology, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03427996
• Other Study ID Numbers: AMCCV2018-02
• First Posted: Feb 9, 2018
• 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 Cardiology, Asan Medical Center: rotational atherectomy
• Additional relevant MeSH terms: Atherosclerosis; Coronary Stenosis; Coronary Artery Disease; Myocardial Ischemia

Study Results

No Results Posted as of Sep 13, 2021