Flow Augmentation Study in Postthrombotic Patients

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03111758

Enrollment

Registered

2017-04-13

Start date

2017-04-03

Completion date

2021-08-05

Last updated

2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postthrombotic Syndrome

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.

Interventions

DEVICEFlow augmentation

Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Time Averaged Maximum Flow Velocity	Five times one minute measurement	time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography (DUS) using its pulse wave Doppler function

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026