A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
1 other identifier
interventional
40
1 country
1
Brief Summary
To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 2, 2016
CompletedFirst Posted
Study publicly available on registry
February 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFebruary 3, 2021
February 1, 2016
1.4 years
February 2, 2016
February 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 weeks
Study Arms (1)
VenaTech Retrievable arm
EXPERIMENTALVenaTech Retrievable arm
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital européen Georges Pompidou
Paris, 75908, France
Related Publications (1)
Dean C, Kim YI, Sanchez O, Martelli N, Sapoval M, Pellerin O. Safety and efficacy of the VenaTech Retrievable inferior vena cava filter: a first-in-man single-center prospective study. CVIR Endovasc. 2022 Oct 4;5(1):50. doi: 10.1186/s42155-022-00325-y.
PMID: 36194306DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2016
First Posted
February 4, 2016
Study Start
September 1, 2015
Primary Completion
February 1, 2017
Study Completion
May 1, 2017
Last Updated
February 3, 2021
Record last verified: 2016-02