Status:
COMPLETED
Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
Lead Sponsor:
Yokohama City University Medical Center
Collaborating Sponsors:
Teikyo University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Phase:
NA
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 thrombu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01460966
Start Date
July 1 2012
End Date
January 31 2017
Last Update
April 20 2017
Active Locations (1)
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1
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024