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

April 19, 2017 updated by: Kiyoshi Hibi, Yokohama City University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Filtrap™+ Thrombus aspiration catheter
Procedure: Filtrap™ + Thrombus aspiration catheter
Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter
ACTIVE_COMPARATOR: Thrombus aspiration catheter
Procedure: Thrombus aspiration catheter
Thrombus aspiration catheter only

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yokohama City University Medical Center

Collaborators

Teikyo University

Investigators

  • Study Chair: Kiyoshi Hibi, Doctor, Yokohama City Universiy Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

December 23, 2015

Study Completion (ACTUAL)

January 31, 2017

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (ESTIMATE)

October 27, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D110922004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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