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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460966
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Teikyo University
Information provided by (Responsible Party):
Kiyoshi Hibi, Yokohama City University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Filtrap™ + Thrombus aspiration catheter Procedure: Thrombus aspiration catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
Study Start Date : July 2012
Actual Primary Completion Date : December 23, 2015
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI) [ Time Frame: a day ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure [ Time Frame: 10months ]
  3. Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline [ Time Frame: 8-12months ]
  4. TIMI flow grade [ Time Frame: 8-12months ]
  5. Corrected TIMI frame count [ Time Frame: 8-12months ]
  6. Myocardial blush grade [ Time Frame: 8-12months ]
  7. Incidence of any revascularization [ Time Frame: 8-12months ]
  8. Incidence of stent thrombosis [ Time Frame: 8-12months ]
  9. Plaque protrusion by IVUS inside the stent [ Time Frame: 8-12months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460966


Locations
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Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Sponsors and Collaborators
Yokohama City University Medical Center
Teikyo University
Investigators
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Study Chair: Kiyoshi Hibi, Doctor Yokohama City Universiy Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kiyoshi Hibi, Yokohama City University Medical Center
ClinicalTrials.gov Identifier: NCT01460966    
Other Study ID Numbers: D110922004
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Keywords provided by Kiyoshi Hibi, Yokohama City University Medical Center:
Distal protection device
Thrombus aspiration
Coronary Artery Disease
Coronary Disease
Acute Coronary Syndrome
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Embolism
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis