NCT00314002

Brief Summary

Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism Study Population: Patients \>/= 18 years of age with massive pulmonary embolism suitable for mechanical thrombectomy with Aspirex 11F. Treatment: Aspirex 11F assisted thrombectomy \_\_\_\_\_\_\_\_\_ The study was terminated early. After having treated seven (7) patients, it was decided in April 2007 that the handling characteristics of the test device should be upgraded before continuing the trial as planned. Therefore, the study was long-term interrupted and finally terminated early. This decision was made by the sponsor in full accordance with the principal investigator. Further studies shall be conducted to show effectiveness and safety of the Aspirex PE catheter thrombectomy device. \_\_\_\_\_\_\_\_\_ Primary Endpoints:

  • Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis or at least contraindication for lysis. Exclusion Criteria:
  • Systemic embolism in the presence of an arterial septal defect or patent foramen ovale.
  • Free floating right heart thrombi, left heart thrombi.
  • Life expectancy, due to underlying disease, less than one month.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2005

Geographic Reach
2 countries

5 active sites

Status
terminated

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

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

First QC Date

April 11, 2006

Last Update Submit

August 6, 2009

Conditions

Pulmonary Embolism

Keywords

Massive pulmonary embolismCatheter thrombectomy

Outcome Measures

Primary Outcomes (2)

  • Immediate decrease in mean pulmonary artery pressure

  • Technical success

Secondary Outcomes (2)

  • Improved flow in the treated main and lobar pulmonary arteries

  • In-hospital mortality will not exceed 20%

Interventions

Mechanical ThrombectomyDEVICE

Eligibility Criteria

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

You may qualify if:

  • Patients \>= 18 years of age with pulmonary embolism and cardiogenic shock, defined as a systolic arterial pressure \<= 90 mmHg, a drop in systolic arterial pressure \>= 40 mmHg for \>= 15 minutes, or ongoing administration of catecholamines for systemic arterial hypotension
  • Subtotal or total filling defect in the left and/or right main pulmonary artery due to massive PE, as assessed by chest computed tomography or by conventional pulmonary angiography
  • Right ventricular dysfunction on echocardiography: RV systolic hypokinesis and/or RV dilation (optional)
  • Failed thrombolysis or at least one of the following contraindications to PE thrombolysis present:
  • Active bleeding
  • History of intracranial bleeding
  • Surgery, delivery, organ biopsy, puncture of a non-compressible vessel within 10 days
  • History of stroke
  • Gastrointestinal bleeding within 10 days
  • Significant trauma within 15 days
  • Head injury requiring hospitalization within 1 year
  • Active cancer with known hemorrhagic risk
  • Neurosurgery or ophthalmologic surgery within the past year
  • Platelets \< 50,000 or INR \>2.0
  • Pregnancy

You may not qualify if:

  • Systemic (paradoxical) embolism in the presence of an atrial septal defect or patent foramen ovale
  • Free floating right heart thrombi, left heart thrombi
  • Life expectancy due to underlying disease less than one month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Herz-Gefässklinik Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

Location

Klinik für Diagnostische Radiologie Christian-Albrechts-Universität Kiel

Kiel, 24105, Germany

Location

Universität Leipzig Herzzentrum

Leipzig, 04289, Germany

Location

Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120, Germany

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Related Publications (1)

  • Kucher N, Windecker S, Banz Y, Schmitz-Rode T, Mettler D, Meier B, Hess OM. Percutaneous catheter thrombectomy device for acute pulmonary embolism: in vitro and in vivo testing. Radiology. 2005 Sep;236(3):852-8. doi: 10.1148/radiol.2363041287. Epub 2005 Jul 12.

    PMID: 16014440BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Nils Kucher, MD

    Universitätsspital Zürich (USZ) Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Study Start

October 1, 2005

Study Completion

April 1, 2007

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

CH(1)DE(4)