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Flow Augmentation Study in Postthrombotic Patients

Primary Purpose

Postthrombotic Syndrome

Status

Terminated

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Flow augmentation

About this trial

This is an interventional prevention trial for Postthrombotic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Maastricht UMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Geko Device

IPCS

Arm Description

Neuromuscular Stimulator

Intermittent Pneumotic Compression Stocking

Outcomes

Primary Outcome Measures

Time Averaged Maximum Flow Velocity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03111758

First Posted

April 7, 2017

Last Updated

February 16, 2022

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03111758

Brief Title

Flow Augmentation Study in Postthrombotic Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

Reaching total sample size was not feasible within the anticipated time frame.

Study Start Date

April 3, 2017 (Actual)

Primary Completion Date

August 5, 2021 (Actual)

Study Completion Date

August 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postthrombotic Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Geko Device

Arm Type

Active Comparator

Arm Description

Neuromuscular Stimulator

Arm Title

IPCS

Arm Type

Active Comparator

Arm Description

Intermittent Pneumotic Compression Stocking

Intervention Type

Device

Intervention Name(s)

Flow augmentation

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Averaged Maximum Flow Velocity

Description

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

Time Frame

Five times one minute measurement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cees Wittens, MD,PhD

Organizational Affiliation

Maastricht University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht UMC

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6202 AZ

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

25403719

Citation

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.

Results Reference

background

PubMed Identifier

24722790

Citation

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.

Results Reference

result

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Flow Augmentation Study in Postthrombotic Patients

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