Venous RecanalisationCHEVROPISNCT05954663
Clinical and Hemodynamic Evaluation After Venous Recanalization of Post-thrombotic Iliofemoral Syndromes
An observational study of Venous Recanalisation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT). The endovascular recanalization and stenting technique has become the gold standard treatment for medically resistant and disabling PTS. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Venous Recanalisation
- What is being tested?
- Basic demographic information
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 26 Feb 2022
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population with a disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis.
Who may be able to join
- Disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis.
Who cannot join
- Inability to consent
- Age <18 years old
- Life expectancy <3 months
- Incomplete medical records
- Lost in follow up
Trial locations and contacts
1 site in 1 country.
About this study
Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT). The endovascular recanalization and stenting technique has become the gold standard treatment for medically resistant and disabling PTS.
Stent thrombosis is a significant complication of this procedure; the risk factors for thrombosis are poorly understood.
Read more
Monitoring the patency of the stent is a key component in maintaining clinical success.
Doppler ultrasound is the first-line diagnostic tool for monitoring patients with venous stents, and has the potential to allow accurate assessment of venous stent obstruction.
Absence of validated morphological and hemodynamic echodoppler criteria for the follow-up of these stents.
- Main objective: Clinical and hemodynamic results of venous recanalisations by stenting in the chronic phase
- Secondary objective (s):
- External validation of hemodynamic criteria proposed in the literature to detect venous stent obstruction
- Risk factors for venous stent restenosis
- Conditions
- Venous Recanalisation
- Being tested
- Basic demographic information
- Keywords
- Post-thrombotic syndrome, Deep vein thrombosisA, Endovascular recanalization and stenting, Morphological and hemodynamic echodoppler criteria, Venous stent restenosis
- Medical subject headings
- Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic demographic informationOther
Basic demographic information: age, sex, weight, height, BMI. Comorbidities: history of major bleeding, cardiovascular comorbidities, diabetes mellitus, renal failure, smoking, hormone therapy Anticoagulant and antiplatelet therapy (molecule, duration and indication, before and after intervention) Procedure data: number and type of stents implanted, diameters and lengths, name of stented venous segments Postoperative complications: bleeding complications, pelvic pain, early thrombosis, early pulmonary embolism
- Clinical examination carried out 1 month after the operation and more than 6 months after the operation
- Data from the control ultrasound performed 1 month after the operation and more than 6 months after the operation
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent venous recanalization by angioplasty-stenting | Patients who underwent venous recanalization by angioplasty-stenting for post-thrombotic iliofemoral syndromes from June 2014 to June 2021. Receives: Other: Basic demographic information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Villalta score
- Score ≤ 4: No TPS.
- Score between 5 and 14: mild TPS.
- Score between 10-14: moderate TPS.
- Score ≥ 15 or ulcer present: severe TPS.
Measured: 6 first month post intervention
Stent patency
Analyze of venous patency of each venous segment Maximum peak flow velocity (in centimetres per second) at each venous segment Location of the implanted stents Cranial and caudal extremity Total length Diameter
Measured: 6 first month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Nov 2020
- Primary completion1 Feb 2022
- Study completion26 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous RecanalisationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954663
- Sponsor's protocol ID
- 69HCL22_1131
- Acronym
- CHEVROPIS
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Hemodynamic Evaluation After Venous Recanalization of Post-thrombotic Iliofemoral Syndromes
- ClinicalTrials.gov ID
- NCT05954663
- Acronym / sponsor ID
- CHEVROPIS / 69HCL22_1131
- Conditions
- Venous Recanalisation
- Keywords
- Post-thrombotic syndrome, Deep vein thrombosisA, Endovascular recanalization and stenting, Morphological and hemodynamic echodoppler criteria, Venous stent restenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 20 Jul 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.
Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT). The endovascular recanalization and stenting technique has become the gold standard treatment for medically resistant and disabling PTS.
Stent thrombosis is a significant complication of this procedure; the risk factors for thrombosis are poorly understood.
Monitoring the patency of the stent is a key component in maintaining clinical success.
Doppler ultrasound is the first-line diagnostic tool for monitoring patients with venous stents, and has the potential to allow accurate assessment of venous stent obstruction.
Absence of validated morphological and hemodynamic echodoppler criteria for the follow-up of these stents.
- Main objective: Clinical and hemodynamic results of venous recanalisations by stenting in the chronic phase
- Secondary objective (s):
- External validation of hemodynamic criteria proposed in the literature to detect venous stent obstruction
- Risk factors for venous stent restenosis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent venous recanalization by angioplasty-stenting | – | Other: Basic demographic informationPatients who underwent venous recanalization by angioplasty-stenting for post-thrombotic iliofemoral syndromes from June 2014 to June 2021. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with a disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis.
Key inclusion criteria (1 listed)
- Disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis.
Key exclusion criteria (5 listed)
- Inability to consent
- Age <18 years old
- Life expectancy <3 months
- Incomplete medical records
- Lost in 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 |
|---|---|---|
| Basic demographic informationBasic demographic information: age, sex, weight, height, BMI. Comorbidities: history of major bleeding, cardiovascular comorbidities, diabetes mellitus, renal failure, smoking, hormone therapy Anticoagulant and antiplatelet therapy (molecule, duration and indication, before and after intervention) Procedure data: number and type of stents implanted, diameters and lengths, name of stented venous segments Postoperative complications: bleeding complications, pelvic pain, early thrombosis, early pulmonary embolism * Clinical examination carried out 1 month after the operation and more than 6 months after the operation * Data from the control ultrasound performed 1 month after the operation and more than 6 months after the operation | Other | Patients who underwent venous recanalization by angioplasty-stenting |
Primary outcome
Clinical improvement
Time frame: 6 first month post intervention
Villalta score * Score ≤ 4: No TPS. * Score between 5 and 14: mild TPS. * Score between 10-14: moderate TPS. * Score ≥ 15 or ulcer present: severe TPS.
Stent patency
Time frame: 6 first month post intervention
Analyze of venous patency of each venous segment Maximum peak flow velocity (in centimetres per second) at each venous segment Location of the implanted stents Cranial and caudal extremity Total length Diameter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Venous Recanalisation, run by Hospices Civils de Lyon 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 5 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: finished, as of the sponsor's last update on 21 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical improvement (time frame: 6 first month post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2023.