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Trial record 10 of 89 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

Drug-Eluting Balloon Registry in Routine Clinical Practice (IRIS DEB)

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ClinicalTrials.gov Identifier: NCT02038660
Recruitment Status : Recruiting
First Posted : January 16, 2014
Last Update Posted : June 27, 2018
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
B. Braun Korea Co., Ltd.
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Brief Summary:
The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.

Condition or disease Intervention/treatment
Coronary Artery Disease Angioplasty, Balloon Device: Balloon angioplasty

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study
Actual Study Start Date : January 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with coronary artery disease Device: Balloon angioplasty



Primary Outcome Measures :
  1. Composite Event [ Time Frame: 1year ]
    Death, Non-fatal myocardial infarction, Target vessel revascularization


Secondary Outcome Measures :
  1. All cause death [ Time Frame: 5year ]
  2. Cardiac death [ Time Frame: 5year ]
  3. Myocardial infarction [ Time Frame: 5year ]
  4. Composite event [ Time Frame: 5year ]
    Death or myocardial infarction

  5. Composite event [ Time Frame: 5year ]
    Cardiac death or myocardial infarction

  6. Target vessel revascularization [ Time Frame: 5year ]
  7. Target lesion revascularization [ Time Frame: 5year ]
  8. Stent thrombosis [ Time Frame: 5year ]
    Classification of stent thrombosis according to Academic Research Consortium criteria

  9. Procedural Success [ Time Frame: 3day ]

    Defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization.

    Participants will be followed for the duration of hospital stay, an expected average of 3days.




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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with balloon angioplasty
Criteria

Inclusion Criteria:

  • After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow
  • Age 20 and more
  • Treated with Balloon angioplasty
  • Signed informed consent and agreed to follow protocol

Exclusion Criteria:

  • Allergy to paclitaxel, antiplatelet
  • History of side effect to heparin, aspirin, thienopyridines
  • History of bleeding tendency, coagulation disorder, blood transfusion reaction

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): NCT02038660


Locations
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Korea, Republic of
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Korea, Republic of
Contact: NAE-HEE LEE, MD       naeheelee@naver.com   
Principal Investigator: NAE-HEE LEE, MD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: CHANG-WOOK NAM, MD       ncwcv@dsmc.or.kr   
Principal Investigator: CHANG-WOOK NAM, MD         
The Catholic University of Korea, Daejeon ST. Mary's Hospital Recruiting
Daejeon, Korea, Republic of
Contact: SUNG-HO HER, MD       hhhsungho@naver.com   
Principal Investigator: SUNG-HO HER, MD         
Dong-A Medical Center Recruiting
Pusan, Korea, Republic of
Contact: MOO-HYUN KIM, MD       kmh60@damc.or.kr   
Principal Investigator: MOO-HYUN KIM, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: SEUNG-JUNG PARK, MD       sjpark@amc.seoul.kr   
Contact: JUNG-HWA LEE       nurse9726@amc.seoul.kr   
Principal Investigator: SEUNG-JUNG PARK, MD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: SEUNG-UN NA, MD       swrha617@yahoo.co.kr   
Principal Investigator: SEUNG-UN NA, MD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: EUN-SEOK SHIN, MD       sesim98@yahoo.co.kr   
Principal Investigator: EUN-SEOK SHIN, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
B. Braun Korea Co., Ltd.

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Responsible Party: Seung-Jung Park, MD,PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02038660     History of Changes
Other Study ID Numbers: AMCCV2013-10
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Keywords provided by Seung-Jung Park, Asan Medical Center:
Coronary Artery Disease
Angioplasty, Balloon

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