Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS) (VAMPIRE3)
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ClinicalTrials.gov Identifier: NCT01460966 |
Recruitment Status :
Completed
First Posted : October 27, 2011
Last Update Posted : April 20, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Procedure: Filtrap™ + Thrombus aspiration catheter Procedure: Thrombus aspiration catheter | Not Applicable |
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 |
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 |
- Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI) [ Time Frame: a day ]
- 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 ]
- Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure [ Time Frame: 10months ]
- Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline [ Time Frame: 8-12months ]
- TIMI flow grade [ Time Frame: 8-12months ]
- Corrected TIMI frame count [ Time Frame: 8-12months ]
- Myocardial blush grade [ Time Frame: 8-12months ]
- Incidence of any revascularization [ Time Frame: 8-12months ]
- Incidence of stent thrombosis [ Time Frame: 8-12months ]
- Plaque protrusion by IVUS inside the stent [ Time Frame: 8-12months ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
Yokohama City University Medical Center | |
Yokohama, Kanagawa, Japan, 232-0024 |
Study Chair: | Kiyoshi Hibi, Doctor | Yokohama City Universiy Medical Center |
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 |
Distal protection device Thrombus aspiration Coronary Artery Disease Coronary Disease Acute Coronary Syndrome |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Embolism Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Embolism and Thrombosis |