Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS) (VAMPIRE3)

Yokohama City University Medical Center

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Procedure: Thrombus aspiration catheter

Procedure: Filtrap™ + Thrombus aspiration catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01460966

D110922004

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Volunteers

No Healthy Volunteers

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