Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Teikyo University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Attenuated plaque ≥ 5mm by intravascular ultrasound(IVUS) was reported to be high risk for distal embolism in Acute coronary syndrome(ACS). The purpose of this study is to assess the effect of thrombus aspiration catheter and distal protection device (filter wire; Filtrap™) in the aforementioned subgroup of patients at high risk for distal embolism.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filtrapâ„¢+ Thrombus aspiration catheter | Active Comparator |
| |
| Thrombus aspiration catheter | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filtrapâ„¢ + Thrombus aspiration catheter | Procedure | Combination of distal protection device (Filtrapâ„¢ )and thrombus aspiration catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI) | a day |
| Measure | Description | Time Frame |
|---|---|---|
| Rise in CK-MB and troponin I or T the next morning after PCI (Peak of CK too in case of ST-segment elevation myocardial infarction ) | a day | |
| Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure |
Not provided
Inclusion Criteria:
Patients who were diagnosed as ACS and meet the following criteria.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kiyoshi Hibi, Doctor | Yokohama City Universiy Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yokohama City University Medical Center | Yokohama | Kanagawa | 232-0024 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30077678 | Derived | Hibi K, Kozuma K, Sonoda S, Endo T, Tanaka H, Kyono H, Koshida R, Ishihara T, Awata M, Kume T, Tanabe K, Morino Y, Tsukahara K, Ikari Y, Fujii K, Yamasaki M, Yamanaka T, Kimura K, Isshiki T; VAMPIRE 3 Investigators. A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound. JACC Cardiovasc Interv. 2018 Aug 27;11(16):1545-1555. doi: 10.1016/j.jcin.2018.03.021. Epub 2018 Aug 1. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 19, 2020 | |
| Reset | Apr 2, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Thrombus aspiration catheter | Procedure | Thrombus aspiration catheter only |
|
| 10months |
| Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline | 8-12months |
| TIMI flow grade | 8-12months |
| Corrected TIMI frame count | 8-12months |
| Myocardial blush grade | 8-12months |
| Incidence of any revascularization | 8-12months |
| Incidence of stent thrombosis | 8-12months |
| Plaque protrusion by IVUS inside the stent | 8-12months |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 19, 2020 | Apr 2, 2020 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided