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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Filtrap™ + Thrombus aspiration catheter
Thrombus aspiration catheter
Sponsored by
Yokohama City University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Distal protection device, Thrombus aspiration, Coronary Artery Disease, Coronary Disease, Acute Coronary Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yokohama City University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Filtrap™+ Thrombus aspiration catheter

Thrombus aspiration catheter

Arm Description

Outcomes

Primary Outcome Measures

Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2011
Last Updated
April 19, 2017
Sponsor
Yokohama City University Medical Center
Collaborators
Teikyo University
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1. Study Identification

Unique Protocol Identification Number
NCT01460966
Brief Title
Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
Acronym
VAMPIRE3
Official Title
Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 23, 2015 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yokohama City University Medical Center
Collaborators
Teikyo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Distal protection device, Thrombus aspiration, Coronary Artery Disease, Coronary Disease, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filtrap™+ Thrombus aspiration catheter
Arm Type
Active Comparator
Arm Title
Thrombus aspiration catheter
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Filtrap™ + Thrombus aspiration catheter
Intervention Description
Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter
Intervention Type
Procedure
Intervention Name(s)
Thrombus aspiration catheter
Intervention Description
Thrombus aspiration catheter only
Primary Outcome Measure Information:
Title
Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)
Time Frame
a day
Secondary Outcome Measure Information:
Title
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
Title
Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure
Time Frame
10months
Title
Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline
Time Frame
8-12months
Title
TIMI flow grade
Time Frame
8-12months
Title
Corrected TIMI frame count
Time Frame
8-12months
Title
Myocardial blush grade
Time Frame
8-12months
Title
Incidence of any revascularization
Time Frame
8-12months
Title
Incidence of stent thrombosis
Time Frame
8-12months
Title
Plaque protrusion by IVUS inside the stent
Time Frame
8-12months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Hibi, Doctor
Organizational Affiliation
Yokohama City Universiy Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30077678
Citation
Hibi K, Kozuma K, Sonoda S, Endo T, Tanaka H, Kyono H, Koshida R, Ishihara T, Awata M, Kume T, Tanabe K, Morino Y, Tsukahara K, Ikari Y, Fujii K, Yamasaki M, Yamanaka T, Kimura K, Isshiki T; VAMPIRE 3 Investigators. A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound. JACC Cardiovasc Interv. 2018 Aug 27;11(16):1545-1555. doi: 10.1016/j.jcin.2018.03.021. Epub 2018 Aug 1.
Results Reference
derived

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

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