NCT03111758

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2021

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

4.3 years

First QC Date

April 7, 2017

Last Update Submit

February 16, 2022

Conditions

Postthrombotic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Time Averaged Maximum Flow Velocity

    time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography (DUS) using its pulse wave Doppler function

    Five times one minute measurement

Study Arms (2)

Geko Device

ACTIVE COMPARATOR

Neuromuscular Stimulator

Device: Flow augmentation

IPCS

ACTIVE COMPARATOR

Intermittent Pneumotic Compression Stocking

Device: Flow augmentation

Interventions

Flow augmentationDEVICE

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

Geko DeviceIPCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-thrombotic obstruction that requires percutaneous intervention through stenting, minimally 18 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Related Publications (2)

  • Summers JA, Clinch J, Radhakrishnan M, Healy A, McMillan V, Morris E, Rua T, Ofuya M, Wang Y, Dimmock PW, Lewis C, Peacock JL, Keevil SF. The geko electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance. Appl Health Econ Health Policy. 2015 Apr;13(2):135-47. doi: 10.1007/s40258-014-0139-0.

    PMID: 25403719BACKGROUND

  • Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.

    PMID: 24722790RESULT

MeSH Terms

Conditions

Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous Insufficiency

Study Officials

  • Cees Wittens, MD,PhD

    Maastricht University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 13, 2017

Study Start

April 3, 2017

Primary Completion

August 5, 2021

Study Completion

August 5, 2021

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations

NL(1)