NCT00370578

Brief Summary

Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI). The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI population. Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2006

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 28, 2007

Status Verified

August 1, 2006

First QC Date

August 9, 2006

Last Update Submit

August 27, 2007

Conditions

Angioplasty

Keywords

STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW

Outcome Measures

Primary Outcomes (2)

  • Limitation of infarct size

  • Early and follow up related (MACE)-major adverse cardiac events

Secondary Outcomes (1)

  • Efficacy of using aspiration device after every stage of Primary angiplasty

Interventions

repeated thrombus aspiration during primary PCIDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with STEMI\<12 from synptoms onset
  • eligble for primary PCI regardless of initial TIMI flow grade.
  • patients for rescue PCI after failed thrombolysis will also be included

You may not qualify if:

  • womwn with known pregnancy or who are lactating
  • pts with allergy to aspirin, clopidogrel or heparin
  • inability to obtain informed consent
  • known existence of life threatening diseases with a life expectency less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek Medical Center

Afula, 18101, Israel

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionThrombosis

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisEmbolism and Thrombosis

Study Officials

  • Yoav Turgeman, MD

    Technion-school of medicine, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YOAV TURGEMAN, MD

CONTACT

972-46494016yoav_t@clalit.org.il

LIMOR ILAN- BUSHARI, MD

CONTACT

972-46495273limor_il@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 31, 2006

Study Start

September 1, 2006

Study Completion

June 1, 2008

Last Updated

August 28, 2007

Record last verified: 2006-08

Locations

IL(1)