Flow Augmentation Study in Postthrombotic Patients

Not Applicable

Terminated

• Conditions: Postthrombotic Syndrome
• Interventions: Device: Flow augmentation

• Registration Number: NCT03111758
• Lead Sponsor: Maastricht University Medical Center

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 Description

Not available

Study Timeline

• Study Start: 2017-04-03
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-13
• Primary Completion: 2021-08-05
• Study Completion: 2021-08-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IPCS	Flow augmentation	Intermittent Pneumotic Compression Stocking
Geko Device	Flow augmentation	Neuromuscular Stimulator

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maastricht UMC; 🇳🇱 Maastricht, Limburg, Netherlands