Post Thrombotic SyndromeSEvERe-PTSNCT05744843
Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome
A study testing exercise and Deep venous stenting in people with Post Thrombotic Syndrome, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The goal of this pilot study and randomised control trial is to compare a smartphone-based exercise programme to deep venous stenting in patients with Post Thrombotic Syndrome. The main questions it aims to answer are: Is exercise as effective as stenting in these patients? What type of exercise is useful in these… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Thrombotic Syndrome
- What is being tested?
- exercise and Deep venous stenting
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2023to Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with symptomatic chronic venous outflow obstruction secondary to PTS or other cause affecting the Inferior Vena Cava (IVC) or iliofemoral vein(s) for greater than 12 months duration AND clinical indication for Deep Venous Stenting.
Who cannot join
- Deep Vein Thrombosis or Pulmonary Embolism within the last 12 months
- Significant or untreated left sided heart disease
- Significant or untreated respiratory disease
- Significant renal disease
- Significant liver disease
- Significant Musculoskeletal or Neurological disease
Show all 12Show fewer
- Active cancer
- Life expectancy of less than 2 years or non-ambulatory status
- Current or Planned pregnancy within the study period
- Any other contraindication to exercise
- Any impairment preventing the provision of informed consent and compliance with study protocol
- Healthy Volunteers in the control group with presence of any arterial or venous disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St. Thomas' Hospital, Guy's and St. Thomas' NHS Foundation Trust
London, SE1 7EH
Ehsanul K Choudhury, MRCS, +44 20 71887188 ext. 53821, ehsanul.choudhury@gstt.nhs.uk
Stephen A Black, FRCS
About this study
Official title: Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome Pilot Study and Randomised Control Trial
The goal of this pilot study and randomised control trial is to compare a smartphone-based exercise programme to deep venous stenting in patients with Post Thrombotic Syndrome.
The main questions it aims to answer are:
Read more
- Is exercise as effective as stenting in these patients?
- What type of exercise is useful in these patients?
- Can exercise be used to improve the results from surgery?
Participants will be split into two groups at random. They will complete a smartphone-based exercise programme or have a deep venous stent.
They will do the following tests before and after.
- Exercise testing
- Calf muscle strength and function tests
- Ultrasound of the deep veins
- Quality of life questionnaires
- Clinical assessment of their disease
They will be compared to healthy volunteers in the pilot study. Investigators will compare exercise to stenting to see if it improves symptoms in these patients. The pilot study will help decide how many patients are needed and what exercise tests will be used for the Randomised control trial.
Read the detailed description
This is a non-commercial pilot study, leading to a randomised control trial.
Primary objective:
- To evaluate smartphone-based exercise as an alternative to stenting in patients with IVC and Iliofemoral vein outflow obstruction secondary to Post Thrombotic Syndrome (PTS).
Secondary objectives:
- To characterise symptomatology and response to different exercise modalities in patients with chronic venous insufficiency.
- Evaluate exercise physiology in patients with chronic venous insufficiency before and after a supervised exercise programme.
- To explore the use of available technologies, such as smart phone applications and wearable devices to deliver a remotely monitored exercise programme.
- To establish a method of assessment of flow (inflow and collateral flow) in patients with symptomatic venous obstruction.
- To understand the impact of stent shape and compression on venous flow and the subsequent patient outcomes.
- To set criteria for the stratification of patient treatment based upon objective and quantitative measures in patients with venous claudication.
Participants will be recruited to the following three groups:
Group 1. Patients with PTS that will undergo remotely supervised exercise Group 2. Patients with PTS that will undergo stenting Group 3. Healthy volunteers
All participants will undergo series of exercise tests and imaging assessments. Participants in group 1 will have these tests repeated at the end of the exercise programme, and group 2 when they attend for their six to eight week follow up visit. Participants in group 1 will be able to re-join the waiting list for stenting on the condition that they have agreement from their named consultant. Investigators anticipate all study activities to be completed before group 1 participants would have received a date for stenting, as current waiting times for stenting is in excess of 18 months.
Patients from both groups 1 and 2 will be loaned an activity tracker (FitBit) to wear. Group 1 will be asked to wear the tracker from day 1 of the exercise programme, group 2 will be asked to wear the tracker from the first post operative day. Both groups will wear the tracker until the follow up visit. This will allow measurement of general activity in both groups and allow for monitoring of compliance with exercise in group 1.
- Conditions
- Post Thrombotic Syndrome
- Being tested
- exercise, Deep venous stenting
- Keywords
- deep venous, exercise, remote, stenting
- Medical subject headings
- Postthrombotic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Also called remote exercise programme, smartphone-based exercise programme
cardiovascular and lower limb strengthening exercise programme
Deep venous stentingProcedure or surgery
Also called Endovascular Stent reconstruction of Deep Vein
Planned surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-based exercise arm | Experimental | Eight to twelve week smartphone delivered exercise programme Receives: Behavioral: exercise |
| Stenting Arm | Active comparator | Deep venous stenting as standard of care Receives: Procedure: Deep venous stenting |
| Healthy Volunteers | No intervention | Healthy Volunteers for baseline testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Villalta score.
0-30, >5 diagnostic of post thrombotic disease. 5-9 is mild disease, 9-4 moderate and >15 Severe. (15 automatically added in the presence of a venous leg ulcer). Change in Villalta score
Measured: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. 3) Study completion, 6 months
Secondary outcomes (5)
VO2 max - maximal oxygen consumption
change in peak VO2 max on cardiopulmonary exercise testing. Increased value indicates improvement, decreased value indicates deterioration
Measured: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
Six minute walk test
change in six minute walk test. Increased distance indicates improvement, decreased distance indicates deterioration.
Measured: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
Incline walk test
Time to onset of symptoms and total incline and speed achieved. Longer time to onset, steeper incline achieved and faster speed acheived indicate improvement.
Measured: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
Calf ejection fraction
change in calf ejection fraction by plethysmography
Measured: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
Venous Insufficiency Epidemiological and Economic Study quality of life and symptoms (VEINES-QoL/Sym) - disease specific quality of life instrument for Chronic Venous Disorders of the Leg
Change in VEINES-QoL/Sym score - higher value indicates better outcome
Measured: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. 3) Study completion, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start5 Sep 2023
- Primary completionOct 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Thrombotic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen A Black, FRCS, Principal investigator, St Thomas' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744843
- Sponsor's protocol ID
- 315612
- Acronym
- SEvERe-PTS
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
PubMed 39968829
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome Pilot Study and Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05744843
- Acronym / sponsor ID
- SEvERe-PTS / 315612
- Conditions
- Post Thrombotic Syndrome
- Keywords
- deep venous, exercise, remote, stenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 27 Feb 2023 (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.
The goal of this pilot study and randomised control trial is to compare a smartphone-based exercise programme to deep venous stenting in patients with Post Thrombotic Syndrome.
The main questions it aims to answer are:
- Is exercise as effective as stenting in these patients?
- What type of exercise is useful in these patients?
- Can exercise be used to improve the results from surgery?
Participants will be split into two groups at random. They will complete a smartphone-based exercise programme or have a deep venous stent.
They will do the following tests before and after.
- Exercise testing
- Calf muscle strength and function tests
- Ultrasound of the deep veins
- Quality of life questionnaires
- Clinical assessment of their disease
They will be compared to healthy volunteers in the pilot study. Investigators will compare exercise to stenting to see if it improves symptoms in these patients. The pilot study will help decide how many patients are needed and what exercise tests will be used for the Randomised control trial.
Detailed description
This is a non-commercial pilot study, leading to a randomised control trial.
Primary objective:
- To evaluate smartphone-based exercise as an alternative to stenting in patients with IVC and Iliofemoral vein outflow obstruction secondary to Post Thrombotic Syndrome (PTS).
Secondary objectives:
- To characterise symptomatology and response to different exercise modalities in patients with chronic venous insufficiency.
- Evaluate exercise physiology in patients with chronic venous insufficiency before and after a supervised exercise programme.
- To explore the use of available technologies, such as smart phone applications and wearable devices to deliver a remotely monitored exercise programme.
- To establish a method of assessment of flow (inflow and collateral flow) in patients with symptomatic venous obstruction.
- To understand the impact of stent shape and compression on venous flow and the subsequent patient outcomes.
- To set criteria for the stratification of patient treatment based upon objective and quantitative measures in patients with venous claudication.
Participants will be recruited to the following three groups:
Group 1. Patients with PTS that will undergo remotely supervised exercise Group 2. Patients with PTS that will undergo stenting Group 3. Healthy volunteers
All participants will undergo series of exercise tests and imaging assessments. Participants in group 1 will have these tests repeated at the end of the exercise programme, and group 2 when they attend for their six to eight week follow up visit. Participants in group 1 will be able to re-join the waiting list for stenting on the condition that they have agreement from their named consultant. Investigators anticipate all study activities to be completed before group 1 participants would have received a date for stenting, as current waiting times for stenting is in excess of 18 months.
Patients from both groups 1 and 2 will be loaned an activity tracker (FitBit) to wear. Group 1 will be asked to wear the tracker from day 1 of the exercise programme, group 2 will be asked to wear the tracker from the first post operative day. Both groups will wear the tracker until the follow up visit. This will allow measurement of general activity in both groups and allow for monitoring of compliance with exercise in group 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smartphone-based exercise arm | Experimental | Behavioral: exerciseEight to twelve week smartphone delivered exercise programme |
| Stenting Arm | Active comparator | Procedure: Deep venous stentingDeep venous stenting as standard of care |
| Healthy Volunteers | No intervention | –Healthy Volunteers for baseline testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic chronic venous outflow obstruction secondary to PTS or other cause affecting the Inferior Vena Cava (IVC) or iliofemoral vein(s) for greater than 12 months duration AND clinical indication for Deep Venous Stenting.
Key exclusion criteria (12 listed)
- Deep Vein Thrombosis or Pulmonary Embolism within the last 12 months
- Significant or untreated left sided heart disease
- Significant or untreated respiratory disease
- Significant renal disease
- Significant liver disease
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 |
|---|---|---|
| exerciseAlso: remote exercise programme, smartphone-based exercise programmecardiovascular and lower limb strengthening exercise programme | Behavioural | Smartphone-based exercise arm |
| Deep venous stentingAlso: Endovascular Stent reconstruction of Deep VeinPlanned surgical intervention | Procedure or surgery | Stenting Arm |
Primary outcome
Villalta score.
Time frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. 3) Study completion, 6 months
0-30, >5 diagnostic of post thrombotic disease. 5-9 is mild disease, 9-4 moderate and >15 Severe. (15 automatically added in the presence of a venous leg ulcer). Change in Villalta score
5 secondary outcomes
VO2 max - maximal oxygen consumption
Time frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
Six minute walk test
Time frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
Incline walk test
Time frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
Calf ejection fraction
Time frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
Venous Insufficiency Epidemiological and Economic Study quality of life and symptoms (VEINES-QoL/Sym) - disease specific quality of life instrument for Chronic Venous Disorders of the Leg
Time frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. 3) Study completion, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 39968829Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
- Individual participant dataSharing planned: No
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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.
Stephen A Black, FRCS principal investigator
St Thomas' 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 exercise and Deep venous stenting in people with Post Thrombotic Syndrome, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 12 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehsanul K Choudhury, MRCS (+44 20 7188 7188 ext. 53821, ehsanul.choudhury@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Villalta score. (time frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. 3) Study completion, 6 months). 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 NCT05744843, which also lists 1 linked publication.
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 13 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.