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OpenTrials
Completed

NCT Number: NCT01460966

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

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.

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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filtrap™ + Thrombus aspiration catheter

Procedure

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

Thrombus aspiration catheter

Procedure

Thrombus aspiration catheter only

Primary outcomes

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

    Time frame: a day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Yokohama City University Medical Center

Other

Collaborators

  • Teikyo University

Registry information

Acronym: VAMPIRE3

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Oct 27, 2011
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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