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

NCT03427996 | Recruiting

• 1 other identifier: AMCCV2018-02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Atherosclerosis, Coronary; Coronary Stenosis

Keywords

rotational atherectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (1)

Coronary disease

Procedure: Rotational atherectomy

Interventions

Rotational atherectomy PROCEDURE

Percutaneous coronary intervention with rotational atherectomy

Coronary disease

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive percutaneous coronary intervention patients receiving rotational atherectomy

You may qualify if:

• 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.

You may not qualify if:

• Life expectancy \<1y

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (8)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

RECRUITING

Daegu Catholic University Medical Center

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

TERMINATED

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

WITHDRAWN

Chonnam National University Hospital

Gwangju, South Korea

NOT YET RECRUITING

Inje University Pusan Paik Hospital

Pusan, South Korea

TERMINATED

Bundang CHA Hospital

Seongnam, South Korea

TERMINATED

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Atherectomy, Coronary

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Central Study Contacts

Seung-jung Park, MD

CONTACT

sjpark@amc.seoul.kr

Jung-hee Ham, RN

CONTACT

82230104728; cvcrc5@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Division of Cardiology

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 9, 2018
• Study Start: September 4, 2018
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2034
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

KR (8)