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| Sponsor: | University Hospital, Geneva |
|---|---|
| Information provided by: | University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT00780767 |
Purpose
This pilot study is mainly aimed to evaluate the feasibility and safety of the percutaneous Angiojet Rheolytic Thrombectomy (ART) in patients presenting a MPE. Secondarily the effectiveness of this treatment modality will also be estimated.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Embolism |
Device: ANGIOJET RHEOLYTIC THROMBECTOMY |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Angiojet Rheolytic Thrombectomy In Case of Massive Pulmonary Embolism A Prospective Single Center Feasibility and Safety Pilot Trial |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients where a hemodynamic stability (SI=1) is hardly obtained despite increasing dose of drug support.
Exclusion Criteria:
Contacts and Locations| Contact: Robert F Bonvini, MD | 0041 22 372 72 00 | robert.bonvini@hcuge.ch |
| Switzerland | |
| Univesity hospital of geneva | Recruiting |
| Geneva, GE, Switzerland, 1211 | |
| Contact: robert f bonvini, md 0041 22 372 72 00 robert.bonvini@hcuge.ch | |
| Principal Investigator: robert f bonvini, md | |
More Information
| Responsible Party: | University Hospital of Geneva |
| ClinicalTrials.gov Identifier: | NCT00780767 History of Changes |
| Other Study ID Numbers: | Angiojet in MPE |
| Study First Received: | October 27, 2008 |
| Last Updated: | October 27, 2008 |
| Health Authority: | Switzerland: Ethical committee university Hospital of Geneva |
|
angiojet massive pulmonary embolism RHEOLYTIC THROMBECTOMY patients presenting with massive pulmonary embolism |
|
Embolism Pulmonary Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |