Clinical Trial: Flow Augmentation Study in Postthrombotic Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome: Time Averaged Maximum Flow Velocity [ Time Frame: Five times one minute measurement ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Maastricht University Medical Center

Dates:
Date Received: April 7, 2017
Date Started: April 3, 2017
Date Completion: October 30, 2017
Last Updated: May 12, 2017
Last Verified: April 2017