Catheter Thrombectomy in Patients With Massive Pulmonary Embolism

This study has been terminated.
(After treatment of 7 patients, it was decided that the handling characteristics of the test device should be upgraded before continuing the trial as planned.)
Sponsor:
Information provided by:
Straub Medical AG
ClinicalTrials.gov Identifier:
NCT00314002
First received: April 11, 2006
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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

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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.

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Primary Endpoints:

  1. Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP).
  2. The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures.

Secondary Endpoints:

  1. Thrombectomy with the Aspirex catheter device is associated with improved flow in the treated main and lobar pulmonary arteries as assessed by the angiographic Miller index.
  2. There will be no significant mechanical haemolysis as assessed by plasma free haemoglobin levels.
  3. In-hospital mortality will not exceed 20%.

Study Design: A prospective international multicenter non-randomized registry assessing the safety and efficacy of the Aspirex 11F mechanical thrombectomy device.

Sample Size: Maximum of 50 patients

Inclusion Criteria:

  • 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.

Condition Intervention Phase
Pulmonary Embolism
Device: Mechanical Thrombectomy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by Straub Medical AG:

Primary Outcome Measures:
  • Immediate decrease in mean pulmonary artery pressure
  • Technical success

Secondary Outcome Measures:
  • Improved flow in the treated main and lobar pulmonary arteries
  • In-hospital mortality will not exceed 20%

Estimated Enrollment: 50
Study Start Date: October 2005
Estimated Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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
  3. Right ventricular dysfunction on echocardiography: RV systolic hypokinesis and/or RV dilation (optional)
  4. 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

Exclusion Criteria

  1. Systemic (paradoxical) embolism in the presence of an atrial septal defect or patent foramen ovale
  2. Free floating right heart thrombi, left heart thrombi
  3. Life expectancy due to underlying disease less than one month
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314002

Locations
Germany
Herz-Gefässklinik Bad Neustadt
Bad Neustadt, Germany, 97616
Klinik für Diagnostische Radiologie Christian-Albrechts-Universität Kiel
Kiel, Germany, 24105
Universität Leipzig Herzzentrum
Leipzig, Germany, 04289
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany, 39120
Switzerland
Kantonsspital Luzern
Luzern, Switzerland, 6000
Sponsors and Collaborators
Straub Medical AG
Investigators
Principal Investigator: Nils Kucher, MD Universitätsspital Zürich (USZ) Switzerland
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00314002     History of Changes
Other Study ID Numbers: APE1
Study First Received: April 11, 2006
Last Updated: August 6, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by Straub Medical AG:
Massive pulmonary embolism
Catheter thrombectomy

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014