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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Filtrap™+ Thrombus aspiration catheter

Group Type ACTIVE_COMPARATOR

Filtrap™ + Thrombus aspiration catheter

Intervention Type PROCEDURE

Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter

Thrombus aspiration catheter

Group Type ACTIVE_COMPARATOR

Thrombus aspiration catheter

Intervention Type PROCEDURE

Thrombus aspiration catheter only

Interventions

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Filtrap™ + Thrombus aspiration catheter

Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter

Intervention Type PROCEDURE

Thrombus aspiration catheter

Thrombus aspiration catheter only

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No