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

Recruiting

• Conditions: Atherosclerosis, Coronary; Coronary Stenosis
• Interventions: Procedure: Rotational atherectomy

• Registration Number: NCT03427996
• Lead Sponsor: Seung-Jung Park

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-09
• Study Start: 2018-09-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2029-12-31
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary disease	Rotational atherectomy	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (8)

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, Korea, Republic of