Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2017-04-03
2021-08-05
Brief Summary
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Stent therapy has been proven to be an effective form of therapy in the treatment of chronic iliofemoral and iliocaval post-thrombotic obstruction. During the first post-intervention day intermittent pneumatic compression stockings (IPCS) are necessary to augment venous flow. This will inherently prevent early stent occlusion. Our aim is to investigate whether the Geko device is effective as IPCS regarding augmentation of flow in post-thrombotic patients during the first day after stenting.
Objective: The primary objective of this study is to identify whether the Geko system is effective in augmenting flow compared to IPCS in post-thrombotic limbs before after stenting.
Study design: Interventional pilot study with randomized cross-sectional design.
Study population: Patients with a post-thrombotic obstruction undergoing a percutaneous procedure (PTA, stenting).
Intervention (if applicable): Treatment with intermittent pneumatic compression stockings (IPCS) and Geko-device.
Main study parameters/endpoints: The main endpoint and parameter of this study is time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography using its pulse wave Doppler function.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Geko Device
Neuromuscular Stimulator
Flow augmentation
Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome
IPCS
Intermittent Pneumotic Compression Stocking
Flow augmentation
Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome
Interventions
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Flow augmentation
Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Cees Wittens, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Hospital
Locations
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Maastricht UMC
Maastricht, Limburg, Netherlands
Countries
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References
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Summers JA, Clinch J, Radhakrishnan M, Healy A, McMillan V, Morris E, Rua T, Ofuya M, Wang Y, Dimmock PW, Lewis C, Peacock JL, Keevil SF. The geko electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance. Appl Health Econ Health Policy. 2015 Apr;13(2):135-47. doi: 10.1007/s40258-014-0139-0.
Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.
Other Identifiers
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NL59864.068.16
Identifier Type: -
Identifier Source: org_study_id
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