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

Coronary Artery Disease Clinical Trial

— VAMPIRE3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460966
• Other study ID #: D110922004
• Status: Completed
• Phase: N/A
• First received: October 17, 2011
• Last updated: April 19, 2017
• Start date: July 2012
• Est. completion date: January 31, 2017

Study information

• Verified date: April 2017
• Source: Yokohama City University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 at high risk for distal embolism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 31, 2017
• Est. primary completion date: December 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Embolism
• Myocardial Ischemia

Intervention

Procedure:
• Filtrap™ + Thrombus aspiration catheter
Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter
• Thrombus aspiration catheter
Thrombus aspiration catheter only

Locations

Country	Name	City	State
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Yokohama City University Medical Center	Teikyo University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)		a day
Secondary	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 )		a day
Secondary	Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure		10months
Secondary	Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline		8-12months
Secondary	TIMI flow grade		8-12months
Secondary	Corrected TIMI frame count		8-12months
Secondary	Myocardial blush grade		8-12months
Secondary	Incidence of any revascularization		8-12months
Secondary	Incidence of stent thrombosis		8-12months
Secondary	Plaque protrusion by IVUS inside the stent		8-12months