Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)

Study Overview
=================
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.

Official Title
-----------------
Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Filtrap™ + Thrombus aspiration catheter
* Procedure: Thrombus aspiration catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filtrap™+ Thrombus aspiration catheter<br> | Procedure: Filtrap™ + Thrombus aspiration catheter<br>* Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter<br>|
| Active Comparator: Thrombus aspiration catheter<br> | Procedure: Thrombus aspiration catheter<br>* Thrombus aspiration catheter only<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI) |  | a day | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Distal protection device, Thrombus aspiration, Coronary Artery Disease, Coronary Disease, Acute Coronary Syndrome