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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 February 2021 |
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Main ID: |
NCT02674672 |
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Date of registration:
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02/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
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Scientific title:
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A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02674672 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pulmonary thrombo-embolism with contraindication to anticoagulation.
- Failure of anticoagulant therapy in thrombo-embolic diseases.
- Prevention of pulmonary embolism in patients with a recent history ( <3 months) of
DVT/ PE who need to undergo urgent surgery at high risk of DVT/PE with temporary
contra-indication to the use of therapeutic doses of anticoagulants.
- Emergency treatment following massive pulmonary embolism where anticipated benefits of
conventional therapy are reduced and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is
contraindicated
Exclusion Criteria:
- The filter should not be implanted in patients with :
- A vena cava which has a diameter < 14 mm or > 28 mm (due to the risk of device
migration)
- Risk of septic embolism
- Known allergy to the materials contained in the kit, allergy to contrast media.
- Severely disabled patients whose life-expectancy, up to 6 months, appears limited
according to the investigator's opinion.
In addition, exclusion criteria are also extended to :
- Patients who cannot be regularly followed up by the participating center
- Subject who already has an implanted vena cava filter
- Subject who has a duplicated IVC
- Subject who has a contrast allergy to both iodinated contrast and non-iodinated
contrast material
- Subject unable to understand information about participation in the study due to a
language barrier, intellectual deficiency, psychiatric problems…
- Subject who has a renal failure (creatinemia clearance < 30ml/min)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Thrombo-embolism
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Intervention(s)
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Device: VenaTech® (VenaTech Retrievable Filter)
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Primary Outcome(s)
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Safety and the efficacy of filter implantation and retrieval by the study of technical success rate of filter placement, and filter removal (when filter removal procedure is schedule) within 12 weeks of implantation
[Time Frame: 12 weeks]
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Secondary ID(s)
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AAG-G-H-1419
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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