ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03427996
Recruitment Status : Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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

Condition or disease Intervention/treatment
Atherosclerosis, Coronary Coronary Stenosis Procedure: Rotational atherectomy

Study Type : Observational
Estimated 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
Estimated Study Start Date : August 31, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2025

Group/Cohort Intervention/treatment
Coronary disease Procedure: Rotational atherectomy
Percutaneous coronary intervention with rotational atherectomy




Primary Outcome Measures :
  1. Target vessel failure (TVF) [ Time Frame: 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 [ Time Frame: 1-,6-, and 12-months, and 3-,5-years ]
  2. Cardiac death [ Time Frame: 1-,6-, and 12-months, and 3-,5-years ]
  3. Myocardial infarction [ Time Frame: 1-,6-, and 12-months, and 3-,5-years ]
  4. Composite of death or myocardial infarction [ Time Frame: 1-,6-, and 12-months, and 3-,5-years ]
  5. Composite of cardiac death or myocardial infarction [ Time Frame: 1-,6-, and 12-months, and 3-,5-years ]
  6. Target-lesion revascularization (TLR) [ Time Frame: 1-,6-, and 12-months, and 3-,5-years ]
  7. Target-vessel revascularization (TVR) [ Time Frame: 1-,6-, and 12-months, and 3-,5-years ]
  8. Stent thrombosis [ Time Frame: 1-,6-, and 12-months, and 3-,5-years ]
    according to Academic Research Consortium (ARC) criteria

  9. Procedural success [ Time Frame: 7 days ]
    Post-procedural diameter stenosis < 30% without death, Q-wave myocardial infarction, or urgent revascularization during the index admission



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive percutaneous coronary intervention patients receiving rotational atherectomy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427996


Contacts
Contact: Seung-jung Park, MD sjpark@amc.seoul.kr
Contact: Jung-hee Ham, RN 82230104728 cvcrc5@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea

Responsible Party: Seung-Jung Park, Professor, Division of Cardiology, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03427996     History of Changes
Other Study ID Numbers: AMCCV2018-02
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
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, Asan Medical Center:
rotational atherectomy

Additional relevant MeSH terms:
Atherosclerosis
Coronary Stenosis
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases