Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeung-Jung Park
About this trial
This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Life expectancy <1y
Trial population
Consecutive percutaneous coronary intervention patients receiving rotational atherectomy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Rotational atherectomy
Procedure/SurgeryPercutaneous coronary intervention with rotational atherectomy
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Coronary disease1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
All death
Time frame
1-,6-, and 12-months, and 3-,5-years2
Cardiac death
Time frame
1-,6-, and 12-months, and 3-,5-years3
Myocardial infarction
Time frame
1-,6-, and 12-months, and 3-,5-years4
Composite of death or myocardial infarction
Time frame
1-,6-, and 12-months, and 3-,5-yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seung-Jung Park
Lead sponsor
Asan Medical Center
Sponsor institution
CardioVascular Research Foundation, Korea
Collaborator
Source ClinicalTrials.gov