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

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01460966
• Lead Sponsor: Yokohama City University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-27
• Study Start: 2012-07
• Primary Completion: 2015-12-23
• Study Completion: 2017-01-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)	a day

Secondary Outcome Measures

Name	Time	Method
Incidence of stent thrombosis	8-12months
Plaque protrusion by IVUS inside the stent	8-12months
Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline	8-12months
Myocardial blush grade	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 clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure	10months
TIMI flow grade	8-12months
Incidence of any revascularization	8-12months
Corrected TIMI frame count	8-12months

Trial Locations

Locations (1)

Yokohama City University Medical Center; 🇯🇵 Yokohama, Kanagawa, Japan