NCT01460966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

October 17, 2011

Last Update Submit

April 19, 2017

Conditions

Coronary Artery Disease

Keywords

Distal protection deviceThrombus aspirationCoronary Artery DiseaseCoronary DiseaseAcute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

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

    a day

Secondary Outcomes (9)

  • 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

  • Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline

    8-12months

  • TIMI flow grade

    8-12months

  • Corrected TIMI frame count

    8-12months

  • +4 more secondary outcomes

Study Arms (2)

Filtrap™+ Thrombus aspiration catheter

ACTIVE COMPARATOR
Procedure: Filtrap™ + Thrombus aspiration catheter

Thrombus aspiration catheter

ACTIVE COMPARATOR
Procedure: Thrombus aspiration catheter

Interventions

Filtrap™ + Thrombus aspiration catheterPROCEDURE

Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter

Filtrap™+ Thrombus aspiration catheter
Thrombus aspiration catheterPROCEDURE

Thrombus aspiration catheter only

Thrombus aspiration catheter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

Related Publications (1)

  • 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.

    PMID: 30077678DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kiyoshi Hibi, Doctor

    Yokohama City Universiy Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yokohama City University Medical Center

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 27, 2011

Study Start

July 1, 2012

Primary Completion

December 23, 2015

Study Completion

January 31, 2017

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

JP(1)