NCT00275990

Brief Summary

The purpose of this study is to determine whether prompt removal of thrombus (blood clot) from a blocked coronary artery using the AngioJet rheolytic thrombectomy device will result in improved blood flow within the heart and a smaller final infarct size (reduced injury to the heart muscle).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
501

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

3.8 years

First QC Date

January 10, 2006

Last Update Submit

October 8, 2014

Conditions

Myocardial Infarction

Keywords

coronary thrombectomythrombectomy for acute myocardial infarctionC14.280.647.500C14.907.553.355.500

Outcome Measures

Primary Outcomes (2)

  • ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG

    30 minutes post procedure

  • Infarction size measured by technetium Tc 99m sestamibi imaging at 30 days

    30 days post-procedure

Secondary Outcomes (4)

  • Post-procedure- TIMI flow, TIMI myocardial blush, and corrected TIMI frame count

    post-procedure

  • 30 days- Technetium Tc 99m sestamibi infarct size, MACE

    30 days post-procedure

  • 6 months- MACE

    6 months post-procedure

  • 12 months- MACE

    12 months post-procedure

Study Arms (2)

thrombectomy before stenting

EXPERIMENTAL

thrombectomy before stenting

Device: rheolytic thrombectomy with direct stenting

directing stenting alone

ACTIVE COMPARATOR

directing stenting alone

Device: direct stenting

Interventions

rheolytic thrombectomy with direct stentingDEVICE
thrombectomy before stenting
direct stentingDEVICE
directing stenting alone

Eligibility Criteria

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

You may qualify if:

  • Patient age \> 18 years
  • ST-segment elevation myocardial infarction
  • Angiographically visible thrombus
  • Presentation within 6 hours of symptom onset for primary percutaneous coronary intervention
  • Patient, or relative or legal guardian,provides written informed consent
  • Patient has no childbearing potential or is not pregnant

You may not qualify if:

  • Prior administration of thrombolysis for current MI
  • Participation in another Study
  • Major surgery within past 6 weeks
  • History of stroke within 30 days, or any history of hemorrhagic stroke
  • Severe hypertension (systolic BP \> 200 mm Hg or diastolic BP \> 110 mm Hg) not controlled on antihypertensive therapy
  • Known neutropenia ( \<1000 neutrophils per mm3) or known severe thrombocytopenia (\< 50,000 platelets per mm3)
  • Known prior history of renal insufficiency
  • Co-morbidities with expected survival \< 1 year
  • Patient unwilling to receive blood products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Careggi Hospital, Division of Cardiology

Florence, Italy

Location

Related Publications (2)

  • Antoniucci D, Valenti R, Migliorini A, Parodi G, Memisha G, Santoro GM, Sciagra R. Comparison of rheolytic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2004 Apr 15;93(8):1033-5. doi: 10.1016/j.amjcard.2004.01.011.

    PMID: 15081450BACKGROUND

  • Migliorini A, Stabile A, Rodriguez AE, Gandolfo C, Rodriguez Granillo AM, Valenti R, Parodi G, Neumann FJ, Colombo A, Antoniucci D; JETSTENT Trial Investigators. Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial. J Am Coll Cardiol. 2010 Oct 12;56(16):1298-306. doi: 10.1016/j.jacc.2010.06.011. Epub 2010 Aug 5.

    PMID: 20691553RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • David Antoniucci, MD

    Azienda Ospedaliero-Universitaria Careggi, Florence, ITALY

    PRINCIPAL INVESTIGATOR

  • Antonio Colombo, MD

    San Raffaelle Hospital, Milan ITALY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

December 1, 2005

Primary Completion

October 1, 2009

Study Completion

August 1, 2010

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

IT(1)