Postthrombotic SyndromeNCT03111758
Flow Augmentation Study in Postthrombotic Patients
A study testing Flow augmentation in people with Postthrombotic Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postthrombotic Syndrome
- What is being tested?
- Flow augmentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Apr 2017to 5 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-thrombotic obstruction that requires percutaneous intervention through stenting, minimally 18 years of age
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flow Augmentation With Geko Device in Patients With Postthrombotic Syndrome a Prospective Randomised Cross-Over Trial
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.
Read more
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
- Being tested
- Flow augmentation
- Medical subject headings
- Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow augmentationDevice
Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome
| Study group | Role | What they receive |
|---|---|---|
| Geko Device | Active comparator | Neuromuscular Stimulator Receives: Device: Flow augmentation |
| IPCS | Active comparator | Intermittent Pneumotic Compression Stocking Receives: Device: Flow augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Averaged Maximum Flow Velocity
time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography (DUS) using its pulse wave Doppler function
Measured: Five times one minute measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start3 Apr 2017
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Why it stopped: Reaching total sample size was not feasible within the anticipated time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postthrombotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cees Wittens, MD,PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111758
- Sponsor's protocol ID
- NL59864.068.16
- Status last verified
- Feb 2022
- First submitted
- 7 Apr 2017
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25403719Williams 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.
PubMed 24722790
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Augmentation With Geko Device in Patients With Postthrombotic Syndrome a Prospective Randomised Cross-Over Trial
- ClinicalTrials.gov ID
- NCT03111758
- Acronym / sponsor ID
- NL59864.068.16
- Conditions
- Postthrombotic Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reaching total sample size was not feasible within the anticipated time frame.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geko Device | Active comparator | Device: Flow augmentationNeuromuscular Stimulator |
| IPCS | Active comparator | Device: Flow augmentationIntermittent Pneumotic Compression Stocking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-thrombotic obstruction that requires percutaneous intervention through stenting, minimally 18 years of age
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow augmentationAugmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome | Device | Geko Device, IPCS |
Primary outcome
Time Averaged Maximum Flow Velocity
Time frame: Five times one minute measurement
time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography (DUS) using its pulse wave Doppler function
Results and safety
The study was stopped early (reason given: Reaching total sample size was not feasible within the anticipated time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 25403719Summers 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 publication: PubMed 24722790Williams 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.
Related trials for Postthrombotic Syndrome
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PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
Deep Vein Thrombosis
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Vflower Stent System for Iliofemoral Vein Stenosis and Occlusion: A Multicenter Real-World Study
Iliofemoral Vein Stenosis, Iliofemoral Vein Occlusion
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DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
Vascular, DVT - Deep Vein Thrombosis
RecruitingPhase 3
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)
Venous Thromboembolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cees Wittens, MD,PhD principal investigator
Maastricht University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow augmentation in people with Postthrombotic Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Reaching total sample size was not feasible within the anticipated time frame.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Averaged Maximum Flow Velocity (time frame: Five times one minute measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03111758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.