Coronary Artery Disease Clinical Trial
— IRIS DEBOfficial title:
Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study
| NCT number | NCT02038660 |
| Other study ID # | AMCCV2013-10 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2014 |
| Est. completion date | June 2028 |
| Verified date | December 2023 |
| Source | Asan Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 1500 |
| Est. completion date | June 2028 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Soon Chun Hyang University Hospital Bucheon | Bucheon | |
| Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
| Korea, Republic of | The Catholic University of Korea, Daejeon ST. Mary's Hospital | Daejeon | |
| Korea, Republic of | Dong-A Medical Center | Pusan | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Gangnam Severance Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Ulsan University Hospital | Ulsan |
| Lead Sponsor | Collaborator |
|---|---|
| Seung-Jung Park | B. Braun Korea Co., Ltd., CardioVascular Research Foundation, Korea |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite Event | Death, Non-fatal myocardial infarction, Target vessel revascularization | 1year | |
| Secondary | All cause death | 5year | ||
| Secondary | Cardiac death | 5year | ||
| Secondary | Myocardial infarction | 5year | ||
| Secondary | Composite event | Death or myocardial infarction | 5year | |
| Secondary | Composite event | Cardiac death or myocardial infarction | 5year | |
| Secondary | Target vessel revascularization | 5year | ||
| Secondary | Target lesion revascularization | 5year | ||
| Secondary | Stent thrombosis | Classification of stent thrombosis according to Academic Research Consortium criteria | 5year | |
| Secondary | Stroke | 5year | ||
| Secondary | Procedural Success | 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. |
3day |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
| Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
| Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
| Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
| Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
| Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
| Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
| Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
| Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
| Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
| Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
| Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
| Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
| Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
| Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
| Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
| Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
| Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
| Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
| Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |