NCT03111758

Flow Augmentation Study in Postthrombotic Patients

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Postthrombotic Syndrome

Interventions

Type	Name	Description
DEVICE	Flow augmentation	Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome

Timeline

• Start date: 2017-04-03
• Primary completion: 2021-08-05
• Completion: 2021-08-05
• First posted: 2017-04-13
• Last updated: 2022-03-04

Locations

1 site across 1 country: Netherlands