Post Thrombotic SyndromeCELEST-LTNCT06046807
Long-Term Post Thrombotic Syndrome Assessment (CELEST Long Term).
An observational study of Post Thrombotic Syndrome, run by Laboratoires Innothera at 1 site in France.
Trial summary
The CELEST Long term is a prospective study, assessing the very long term risk of post thrombotic syndrome (PTS) in patients enrolled in the CELEST double-blind RCT. All patients enrolled in CELEST RCT will benefit from a 7-year follow-up visit conducted over the phone. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post Thrombotic Syndrome
- What is being tested?
- Phone call
- How many people
- 288 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2023to 24 Dec 2023
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were enrolled in the CELEST RCT
Who may be able to join
- Patients enrolled and followed in the CELEST RCT*
Who cannot join
- Patients who withdrew consent or died during the 2-year follow-up of the CELEST RCT.
- Patients who decline or are unable to participate (including severe memory loss issues) to the long-term follow-up
- CELEST RCT main inclusion/exclusion criteria were: adult (>18 years at time of enrolment) patients first unilateral acute symptomatic proximal lower limb DVT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determine the Proportion of Patients With Disabling Post Thrombotic Syndrome (Moderate or Severe) in the Long Term Within the Cohort of Patients Who Participated in the Trial CELEST Therapy.
The CELEST Long term is a prospective study, assessing the very long term risk of post thrombotic syndrome (PTS) in patients enrolled in the CELEST double-blind RCT. All patients enrolled in CELEST RCT will benefit from a 7-year follow-up visit conducted over the phone. The primary objective is to assess the proportion of patients with moderate-severe PTS assessed with the patient reported Villalta score and the 2 main secondary objectives are to assess predictors of moderate to severe PTS and the impact of initial compression stockings strength (25mmHg vs. 35mmHg) on the development of moderate-severe PTS. Up to 288 patients may participate.
The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial compression stockings strengths on the risk of PTS.
Read the detailed description
The CELEST double blind RCT demonstrated that 25mmHg elastic compression stockings (ECS) were non inferior to 35mmHg ECS to prevent post thrombotic syndrome (PTS) 2 years after a first proximal deep vein thrombosis (DVT). Likely because of lack of statistical power the investigators were not able to demonstrate that 25mmHg ECS were superior in the overall RCT population and that 35mmHg ECS were superior in patients optimally adherent to ECS. Furthermore, few data are available on the very long term (>5 years).
The CELEST Long term is a prospective study, assessing the very long term risk of PTS in patients enrolled in the CELEST RCT. All patients enrolled in CELEST RCT and willing to participate are eligible and will benefit from a 7-year follow-up visit conducted over the phone.
Primary objective is to assess the proportion of patients with moderate-severe PTS defined as a patient reported Villalta score (PRVS) ≥10 or a venous leg ulcer ipsilateral to index DVT. Secondary objectives include predictors of moderate to severe PTS, impact of initial ECS strength on the development of moderate-severe PTS, impact of anticoagulant treatment (type and duration) on the development of moderate to severe PTS, proportion of PTS (defined as PRVS≥5 or ipsilateral leg ulcer) and impact of PTS on patient's QOL. Study should last 1 year and up to 288 patients may participate.
The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial CE strengths on the risk of PTS.
- Conditions
- Post Thrombotic Syndrome
- Being tested
- Phone call
- Keywords
- Post thrombotic syndrome, Elastic compression stockings, long-term follow-up, Deep vein Thrombosis
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callOther
This follow-up will be conducted over the phone and by mail (some questionnaire may be sent by patient, as per his/her preference)
| Study group | Role | What they receive |
|---|---|---|
| 35mmHg ECS | Subjects with first proximal DVT allocated to wear 35 mmHg elastic compression stockings (ECS) for 2 years during the CELEST RCT Receives: Other: Phone call | |
| 25mmHg ECS | Subjects with first proximal DVT allocated to wear 25 mmHg elastic compression stockings (ECS) for 2 years during the CELEST RCT Receives: Other: Phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with moderate-severe PTS in the whole cohort
PTS defined with the patient reported Villalta score (PRVS). Moderate-severe PTS: PRVS≥10 or presence of a venous leg ulcer in the leg ipsilateral to index DVT
The Villalta score consists in 11 questions (5 on subjective symptoms and 6 on objective signs).
Each question is coded between 0 and 3 (0: none - 1: mild - 2: moderate - 3: severe). The total score is the sum of the 11 questions and therefore ranges from 0 to 33, where a high value indicates a high level of disability.
An additional question asks about the presence of ulcers. If the calculated score is < 15, a value of 15 is assigned to the ulcer score.
The thresholds used are as follows:
- presence of PTS if Villalta ≥ 5
- presence of disabling PTS (moderate, severe) if Villalta ≥ 10
- presence of severe PTS if Villalta ≥ 15
Measured: At the phone follow-up up to 3 months
Secondary outcomes (11)
Predictors of moderate-severe PTS
Predictors of moderate-severe PTS in the whole cohort
Measured: Since enrolment in the CELEST CRT
Impact of initial ECS strength on the development of moderate-severe PTS
Comparison of proportion of moderate-severe PTS between patients randomized in the 25mmHg ECS vs. 35mmHg ECS group
Measured: Since enrollment in the CELEST study
Impact of initial type of ECS on the development of moderate-severe PTS
Comparison of proportion of moderate-severe PTS between patients who chose to wear above knee vs. below knee ECS during CELEST RCT
Measured: Since enrollment in the CELEST study
Impact of adherence to RCT's ECS on the development of moderate-severe PTS
Comparison of proportion of moderate-severe PTS according to adherence to ECS during CELEST RCT
Measured: Since enrollment in the CELEST study
Assessment of the use of ECS after the end of the RCT in terms of use, strength, length, adherence, duration
Description of the use of ECS among study participants since the end of their participation in the CELEST RCT
Measured: Since enrolment in the CELEST study with focus on the period end of RCT to long-term follow-up
Factors influencing the the decision to continue, stop or resume ECS
Description of the reasons that led to the decision to continue, stop or resume ECS
Measured: During the 2-year celest study and during the long-term follow-up
Impact of anticoagulant treatment on the development of moderate-severe PTS
Comparison of proportion of moderate-severe PTS according to type and duration of anticoagulant treatment during CELEST RCT
Measured: During the 2-year celest study and during the long-term follow-up
Proportion of patients with any PTS
PTS present if PRVS≥5 or presence of a venous leg ulcer in the leg ipsilateral to index DVT
Measured: At the phone follow-up up to 3 months
Predictors of any PTS
Predictors of PTS (defined as a PRVS≥5 or presence of a venous leg ulcer in the leg ipsilateral to index DVT) in the whole cohort
Measured: At the phone follow-up up to 3 months
Proportion of patients who developed a serious adverse events (SAE) in the cohort
SAEs assessed are death, venous thromboembolic recurrence, major bleeding and peripheral arterial disease. SAEs are defined according to the International Society on Thrombosis and Haemostasis criteria. These events will be adjudicated by the study adjudication committee
Measured: During the 2-year celest study and during the long-term follow-up
Impact of PTS on patients' quality of life
Comparison of QOL scores according to the presence or absence of PTS and its severity; QOL will be assessed using CIVIQ-20 questionnaire
Measured: At the phone follow-up up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start24 Jul 2023
- Primary completion24 Oct 2023 (estimated)
- Study completion24 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Innothera
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Floralis
- Responsible party
- Sponsor
- Investigators
- Jean Luc Bosson, MD, PhD, Principal investigator, University Grenoble Alpes, FranceJean Philippe Galanaud, MD, PhD, Principal investigator, University of Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046807
- Sponsor's protocol ID
- 2023-A00528-37
- Acronym
- CELEST-LT
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Relevant deidentified participant data (with a data dictionary) will be available to other researchers on reasonable request after publication, approval from both principal investigators and sponsor, and after a data access agreement is signed
Publications
Ten Cate-Hoek AJ. Lower strength stockings: is less better? Lancet Haematol. 2022 Dec;9(12):e865-e866. doi: 10.1016/S2352-3026(22)00266-6. No abstract available.
PubMed 36455603Utne KK, Ghanima W, Foyn S, Kahn S, Sandset PM, Wik HS. Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome. Thromb Haemost. 2016 Jan;115(2):361-367. doi: 10.1160/th15-04-0318. Epub 2015 Sep 17.
PubMed 26422814Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.
PubMed 23682905Kaatz S, Ahmad D, Spyropoulos AC, Schulman S; Subcommittee on Control of Anticoagulation. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26. doi: 10.1111/jth.13140. No abstract available.
PubMed 26764429Kraaijpoel N, Tritschler T, Guillo E, Girard P, Le Gal G. Definitions, adjudication, and reporting of pulmonary embolism-related death in clinical studies: A systematic review. J Thromb Haemost. 2019 Oct;17(10):1590-1607. doi: 10.1111/jth.14570. Epub 2019 Jul 31.
PubMed 31301689Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54. doi: 10.1007/BF00439228.
PubMed 8993100Makedonov I, Kahn SR, Galanaud JP. Prevention and Management of the Post-Thrombotic Syndrome. J Clin Med. 2020 Mar 27;9(4):923. doi: 10.3390/jcm9040923.
PubMed 32230912Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available.
PubMed 25246013Galanaud JP, Genty-Vermorel C, Barrellier MT, Becker F, Jabbour V, Blaise S, Bura-Riviere A, Comte A, Grange C, Guenneguez H, Maufus M, Ouvry P, Richaud C, Rolland C, Schmidt J, Sevestre MA, Verriere F, Bosson JL; CELEST trial investigators. 25 mm Hg versus 35 mm Hg elastic compression stockings to prevent post-thrombotic syndrome after deep vein thrombosis (CELEST): a randomised, double-blind, non-inferiority trial. Lancet Haematol. 2022 Dec;9(12):e886-e896. doi: 10.1016/S2352-3026(22)00247-2.
PubMed 36455606Galanaud JP, Genty-Vermorel C, Rolland C, Comte A, Ouvry P, Bertaina I, Verriere F, Bosson JL. Compression stockings to prevent postthrombotic syndrome: Literature overview and presentation of the CELEST trial. Res Pract Thromb Haemost. 2020 Oct 30;4(8):1239-1250. doi: 10.1002/rth2.12445. eCollection 2020 Nov.
PubMed 33313464
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Proportion of Patients With Disabling Post Thrombotic Syndrome (Moderate or Severe) in the Long Term Within the Cohort of Patients Who Participated in the Trial CELEST Therapy.
- ClinicalTrials.gov ID
- NCT06046807
- Acronym / sponsor ID
- CELEST-LT / 2023-A00528-37
- Conditions
- Post Thrombotic Syndrome
- Keywords
- Post thrombotic syndrome, Elastic compression stockings, long-term follow-up, Deep vein Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Laboratoires InnotheraIndustry (pharma, biotech, devices)
- Collaborators
- Floralis
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 24 Oct 2023 (estimated)
- Study completion
- 24 Dec 2023 (estimated)
- First posted
- 21 Sep 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 CELEST Long term is a prospective study, assessing the very long term risk of post thrombotic syndrome (PTS) in patients enrolled in the CELEST double-blind RCT. All patients enrolled in CELEST RCT will benefit from a 7-year follow-up visit conducted over the phone. The primary objective is to assess the proportion of patients with moderate-severe PTS assessed with the patient reported Villalta score and the 2 main secondary objectives are to assess predictors of moderate to severe PTS and the impact of initial compression stockings strength (25mmHg vs. 35mmHg) on the development of moderate-severe PTS. Up to 288 patients may participate.
The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial compression stockings strengths on the risk of PTS.
Detailed description
The CELEST double blind RCT demonstrated that 25mmHg elastic compression stockings (ECS) were non inferior to 35mmHg ECS to prevent post thrombotic syndrome (PTS) 2 years after a first proximal deep vein thrombosis (DVT). Likely because of lack of statistical power the investigators were not able to demonstrate that 25mmHg ECS were superior in the overall RCT population and that 35mmHg ECS were superior in patients optimally adherent to ECS. Furthermore, few data are available on the very long term (>5 years).
The CELEST Long term is a prospective study, assessing the very long term risk of PTS in patients enrolled in the CELEST RCT. All patients enrolled in CELEST RCT and willing to participate are eligible and will benefit from a 7-year follow-up visit conducted over the phone.
Primary objective is to assess the proportion of patients with moderate-severe PTS defined as a patient reported Villalta score (PRVS) ≥10 or a venous leg ulcer ipsilateral to index DVT. Secondary objectives include predictors of moderate to severe PTS, impact of initial ECS strength on the development of moderate-severe PTS, impact of anticoagulant treatment (type and duration) on the development of moderate to severe PTS, proportion of PTS (defined as PRVS≥5 or ipsilateral leg ulcer) and impact of PTS on patient's QOL. Study should last 1 year and up to 288 patients may participate.
The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial CE strengths on the risk of PTS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 35mmHg ECS | – | Other: Phone callSubjects with first proximal DVT allocated to wear 35 mmHg elastic compression stockings (ECS) for 2 years during the CELEST RCT |
| 25mmHg ECS | – | Other: Phone callSubjects with first proximal DVT allocated to wear 25 mmHg elastic compression stockings (ECS) for 2 years during the CELEST RCT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were enrolled in the CELEST RCT
Key inclusion criteria (1 listed)
- Patients enrolled and followed in the CELEST RCT*
Key exclusion criteria (3 listed)
- Patients who withdrew consent or died during the 2-year follow-up of the CELEST RCT.
- Patients who decline or are unable to participate (including severe memory loss issues) to the long-term follow-up
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 |
|---|---|---|
| Phone callThis follow-up will be conducted over the phone and by mail (some questionnaire may be sent by patient, as per his/her preference) | Other | 25mmHg ECS, 35mmHg ECS |
Primary outcome
Proportion of patients with moderate-severe PTS in the whole cohort
Time frame: At the phone follow-up up to 3 months
PTS defined with the patient reported Villalta score (PRVS). Moderate-severe PTS: PRVS≥10 or presence of a venous leg ulcer in the leg ipsilateral to index DVT The Villalta score consists in 11 questions (5 on subjective symptoms and 6 on objective signs). Each question is coded between 0 and 3 (0: none - 1: mild - 2: moderate - 3: severe). The total score is the sum of the 11 questions and therefore ranges from 0 to 33, where a high value indicates a high level of disability. An additional question asks about the presence of ulcers. If the calculated score is < 15, a value of 15 is assigned to the ulcer score. The thresholds used are as follows: * presence of PTS if Villalta ≥ 5 * presence of disabling PTS (moderate, severe) if Villalta ≥ 10 * presence of severe PTS if Villalta ≥ 15
11 secondary outcomes
Predictors of moderate-severe PTS
Time frame: Since enrolment in the CELEST CRT
Impact of initial ECS strength on the development of moderate-severe PTS
Time frame: Since enrollment in the CELEST study
Impact of initial type of ECS on the development of moderate-severe PTS
Time frame: Since enrollment in the CELEST study
Impact of adherence to RCT's ECS on the development of moderate-severe PTS
Time frame: Since enrollment in the CELEST study
Assessment of the use of ECS after the end of the RCT in terms of use, strength, length, adherence, duration
Time frame: Since enrolment in the CELEST study with focus on the period end of RCT to long-term follow-up
Factors influencing the the decision to continue, stop or resume ECS
Time frame: During the 2-year celest study and during the long-term follow-up
Impact of anticoagulant treatment on the development of moderate-severe PTS
Time frame: During the 2-year celest study and during the long-term follow-up
Proportion of patients with any PTS
Time frame: At the phone follow-up up to 3 months
Predictors of any PTS
Time frame: At the phone follow-up up to 3 months
Proportion of patients who developed a serious adverse events (SAE) in the cohort
Time frame: During the 2-year celest study and during the long-term follow-up
Impact of PTS on patients' quality of life
Time frame: At the phone follow-up up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 36455603Ten Cate-Hoek AJ. Lower strength stockings: is less better? Lancet Haematol. 2022 Dec;9(12):e865-e866. doi: 10.1016/S2352-3026(22)00266-6. No abstract available.
- Background: PubMed 26422814Utne KK, Ghanima W, Foyn S, Kahn S, Sandset PM, Wik HS. Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome. Thromb Haemost. 2016 Jan;115(2):361-367. doi: 10.1160/th15-04-0318. Epub 2015 Sep 17.
- Background: PubMed 23682905Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.
- Background: PubMed 26764429Kaatz S, Ahmad D, Spyropoulos AC, Schulman S; Subcommittee on Control of Anticoagulation. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26. doi: 10.1111/jth.13140. No abstract available.
- Background: PubMed 31301689Kraaijpoel N, Tritschler T, Guillo E, Girard P, Le Gal G. Definitions, adjudication, and reporting of pulmonary embolism-related death in clinical studies: A systematic review. J Thromb Haemost. 2019 Oct;17(10):1590-1607. doi: 10.1111/jth.14570. Epub 2019 Jul 31.
- Background: PubMed 8993100Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54. doi: 10.1007/BF00439228.
- Background: PubMed 32230912Makedonov I, Kahn SR, Galanaud JP. Prevention and Management of the Post-Thrombotic Syndrome. J Clin Med. 2020 Mar 27;9(4):923. doi: 10.3390/jcm9040923.
- Background: PubMed 25246013Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available.
- Results publication: PubMed 36455606Galanaud JP, Genty-Vermorel C, Barrellier MT, Becker F, Jabbour V, Blaise S, Bura-Riviere A, Comte A, Grange C, Guenneguez H, Maufus M, Ouvry P, Richaud C, Rolland C, Schmidt J, Sevestre MA, Verriere F, Bosson JL; CELEST trial investigators. 25 mm Hg versus 35 mm Hg elastic compression stockings to prevent post-thrombotic syndrome after deep vein thrombosis (CELEST): a randomised, double-blind, non-inferiority trial. Lancet Haematol. 2022 Dec;9(12):e886-e896. doi: 10.1016/S2352-3026(22)00247-2.
- Results publication: PubMed 33313464Galanaud JP, Genty-Vermorel C, Rolland C, Comte A, Ouvry P, Bertaina I, Verriere F, Bosson JL. Compression stockings to prevent postthrombotic syndrome: Literature overview and presentation of the CELEST trial. Res Pract Thromb Haemost. 2020 Oct 30;4(8):1239-1250. doi: 10.1002/rth2.12445. eCollection 2020 Nov.
- Individual participant dataSharing planned: Undecided. Relevant deidentified participant data (with a data dictionary) will be available to other researchers on reasonable request after publication, approval from both principal investigators and sponsor, and after a data access agreement is signed
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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.
Jean Luc Bosson, MD, PhD principal investigator
University Grenoble Alpes, France
Jean Philippe Galanaud, MD, PhD principal investigator
University of Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Thrombotic Syndrome, run by Laboratoires Innothera at 1 site in France.
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 3 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 21 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 France. 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 Carole Rolland, MSc (04 76 76 50 40, carole.rolland@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with moderate-severe PTS in the whole cohort (time frame: At the phone follow-up up to 3 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 NCT06046807, which also lists 10 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 21 Sep 2023.