Coronary Artery DiseaseVAMPIRE3NCT01460966
Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
A study testing Filtrap™ + Thrombus aspiration catheter and Thrombus aspiration catheter in people with Coronary Artery Disease, run by Yokohama City University Medical Center at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Filtrap™ + Thrombus aspiration catheter and Thrombus aspiration catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2012to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Ineligible for PCI
- Lactating and (possibly) pregnant woman or having possibility of pregnant
- Patients who are considered ineligible by the attending physician
Trial locations and contacts
1 site in 1 country.
Japan1 site
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Filtrap™ + Thrombus aspiration catheter, Thrombus aspiration catheter
- Keywords
- Distal protection device, Thrombus aspiration, Coronary Artery Disease, Coronary Disease, Acute Coronary Syndrome
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtrap™ + Thrombus aspiration catheterProcedure or surgery
Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter
Thrombus aspiration catheterProcedure or surgery
Thrombus aspiration catheter only
| Study group | Role | What they receive |
|---|---|---|
| Filtrap™+ Thrombus aspiration catheter | Active comparator | Not described Receives: Procedure: Filtrap™ + Thrombus aspiration catheter |
| Thrombus aspiration catheter | Active comparator | Not described Receives: Procedure: Thrombus aspiration catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)
Measured: 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 )
Measured: a day
Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure
Measured: 10months
Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline
Measured: 8-12months
TIMI flow grade
Measured: 8-12months
Corrected TIMI frame count
Measured: 8-12months
Myocardial blush grade
Measured: 8-12months
Incidence of any revascularization
Measured: 8-12months
Incidence of stent thrombosis
Measured: 8-12months
Plaque protrusion by IVUS inside the stent
Measured: 8-12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startJul 2012
- Primary completion23 Dec 2015
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Teikyo University
- Responsible party
- Principal investigator, Kiyoshi Hibi, Yokohama City University Medical Center
- Investigators
- Kiyoshi Hibi, Doctor, Study chair, Yokohama City Universiy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460966
- Sponsor's protocol ID
- D110922004
- Acronym
- VAMPIRE3
- Status last verified
- Apr 2017
- First submitted
- 17 Oct 2011
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30077678
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
- ClinicalTrials.gov ID
- NCT01460966
- Acronym / sponsor ID
- VAMPIRE3 / D110922004
- Conditions
- Coronary Artery Disease
- Keywords
- Distal protection device, Thrombus aspiration, Coronary Artery Disease, Coronary Disease, Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Collaborators
- Teikyo University
- Study start
- Jul 2012
- Primary completion
- 23 Dec 2015 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filtrap™+ Thrombus aspiration catheter | Active comparator | Procedure: Filtrap™ + Thrombus aspiration catheter |
| Thrombus aspiration catheter | Active comparator | Procedure: Thrombus aspiration catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filtrap™ + Thrombus aspiration catheterCombination of distal protection device (Filtrap™ )and thrombus aspiration catheter | Procedure or surgery | Filtrap™+ Thrombus aspiration catheter |
| Thrombus aspiration catheterThrombus aspiration catheter only | Procedure or surgery | Thrombus aspiration catheter |
Primary outcome
Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)
Time frame: a day
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Derived from this study: PubMed 30077678Hibi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiyoshi Hibi, Doctor study chair
Yokohama City Universiy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filtrap™ + Thrombus aspiration catheter and Thrombus aspiration catheter in people with Coronary Artery Disease, run by Yokohama City University Medical Center at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI) (time frame: a day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01460966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.