Coronary Artery Disease
Conditions
Keywords
Distal protection device, Thrombus aspiration, Coronary Artery Disease, Coronary Disease, Acute Coronary Syndrome
Brief summary
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.
Interventions
PROCEDUREFiltrap™ + Thrombus aspiration catheter
Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter
PROCEDUREThrombus aspiration catheter
Thrombus aspiration catheter only
Sponsors
Teikyo University
Yokohama City University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients who were diagnosed as ACS and meet the following criteria. * Patients with acute myocardial infarction or unstable angina within 2 months from onset. * Patients who have severe coronary stenosis which require PCI and in whom attenuated plaque ≥ 5mm (longitudinally) by IVUS before PCI is observed prior to balloon dilatation and stent deployment.
Exclusion criteria
* Patients who need balloon expansion (including small diameter balloon) for IVUS catheter crossing. * Patients who were resuscitated after dead on arrival * Graft lesion or in-stent restenosis lesion * Patients on dialysis or renal failure (Cr\>1.5mg/dl). * Left main trunk lesion * Target vessel size is \<2.5mm or \>5mm * Ineligible for PCI * Lactating and (possibly) pregnant woman or having possibility of pregnant * Patients who are considered ineligible by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI) | a day |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure | 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 |
| 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 any revascularization | 8-12months |
| Incidence of stent thrombosis | 8-12months |
| Plaque protrusion by IVUS inside the stent | 8-12months |
| Myocardial blush grade | 8-12months |
Countries
Japan
Outcome results
None listed