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Catheter Thrombectomy in Patients With Massive Pulmonary Embolism

NCT00314002 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-08-07

No results posted yet for this study

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

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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.

Conditions

Interventions

DEVICE

Mechanical Thrombectomy

Sponsors & Collaborators

  • Straub Medical AG

    lead INDUSTRY

Principal Investigators

  • Nils Kucher, MD · Universitätsspital Zürich (USZ) Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Completion
2007-04-30

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00314002 on ClinicalTrials.gov