Recruiting NCT03427996
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rotational atherectomy.
- Who it may be relevant to
- Registry conditions: Atherosclerosis, Coronary, Coronary Stenosis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Overview
This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.
Interventions
- Procedure Rotational atherectomy
Percutaneous coronary intervention with rotational atherectomy
Primary outcome measures
- Target vessel failure (TVF) [Time frame: 1 year]
Secondary outcome measures (10)
- All death [Time frame: 1-,6-, and 12-months, and 3-,5-years]
- Cardiac death [Time frame: 1-,6-, and 12-months, and 3-,5-years]
- Myocardial infarction [Time frame: 1-,6-, and 12-months, and 3-,5-years]
- Composite of death or myocardial infarction [Time frame: 1-,6-, and 12-months, and 3-,5-years]
- Composite of cardiac death or myocardial infarction [Time frame: 1-,6-, and 12-months, and 3-,5-years]
- Target-lesion revascularization (TLR) [Time frame: 1-,6-, and 12-months, and 3-,5-years]
- Target-vessel revascularization (TVR) [Time frame: 1-,6-, and 12-months, and 3-,5-years]
- Stent thrombosis [Time frame: 1-,6-, and 12-months, and 3-,5-years]
- Stroke [Time frame: 1-,6-, and 12-months, and 3-,5-years]
- Procedural success [Time frame: 7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 8 centers
- Soon Chun Hyang University Hospital Bucheon — Bucheon-si
- Daegu Catholic University Medical Center — Daegu
- Chungnam National University Hospital — Daejeon
- The Catholic University of Korea, Daejeon ST. Mary's Hospital — Daejeon
- Chonnam National University Hospital — Gwangju
- Inje University Pusan Paik Hospital — Pusan
- Bundang CHA Hospital — Seongnam
- Asan Medical Center — Seoul
Identifiers
NCT: NCT03427996 · AMCCV2018-02