Clinical trial NCT01460966: Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
Official title: Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Distal protection device
Thrombus aspiration
Coronary Artery Disease
Coronary Disease
Acute Coronary Syndrome
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
Collaborators: name: Teikyo University
First posted: 2011-10-27
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)
timeFrame: a day
Secondary outcomes:
measure: 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 )
timeFrame: a day
measure: Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure
timeFrame: 10months
measure: Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline
timeFrame: 8-12months
measure: TIMI flow grade
timeFrame: 8-12months
measure: Corrected TIMI frame count
timeFrame: 8-12months
measure: Myocardial blush grade
timeFrame: 8-12months
measure: Incidence of any revascularization
timeFrame: 8-12months
measure: Incidence of stent thrombosis
timeFrame: 8-12months
measure: Plaque protrusion by IVUS inside the stent
timeFrame: 8-12months
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
Study officials:
affiliation: Yokohama City Universiy Medical Center
name: Kiyoshi Hibi, Doctor
role: STUDY_CHAIR
References:
citation: 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.