Flow Augmentation Study in Postthrombotic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Flow Augmentation With Geko Device in Patients With Postthrombotic Syndrome a Prospective Randomised Cross-Over Trial

Conditions
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Postthrombotic Syndrome

Intervention / Treatment
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* Device: Flow augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-thrombotic obstruction that requires percutaneous intervention through stenting, minimally 18 years of age Exclusion Criteria: Peripheral arterial disease, comorbidities leading to impaired muscle function of either lower limb, co-morbidities affecting the circulatory system, history of deep venous surgery in either lower limb or groin, allergies to the plasters, pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Geko Device<br>Neuromuscular Stimulator | Device: Flow augmentation<br>* Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome<br>|
| Active Comparator: IPCS<br>Intermittent Pneumotic Compression Stocking | Device: Flow augmentation<br>* Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |