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Flow Augmentation Study in Postthrombotic Patients

NCT03111758 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-04

No results posted yet for this study

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

DEVICE

Flow augmentation

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

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Cees Wittens, MD,PhD · Maastricht University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2021-08-05
Completion
2021-08-05

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03111758 on ClinicalTrials.gov