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Reaching total sample size was not feasible within the anticipated time frame.
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Rationale:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geko Device | Active Comparator | Neuromuscular Stimulator |
|
| IPCS | Active Comparator | Intermittent Pneumotic Compression Stocking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flow augmentation | Device | Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Averaged Maximum Flow Velocity | time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography (DUS) using its pulse wave Doppler function | Five times one minute measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cees Wittens, MD,PhD | Maastricht University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht UMC | Maastricht | Limburg | 6202 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25403719 | Background | 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. | |
| 24722790 |
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| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| 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. |
| D002318 |
| Cardiovascular Diseases |
| D014689 | Venous Insufficiency |