Iliofemoral Venous ThrombosisPhase 4PMT-DVTNCT06472518
Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
A Phase 4 study testing pharmaco mechanical thrombolysis in people with Iliofemoral Venous Thrombosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Iliofemoral DVTs (IF DVTs) are vascular disorders associated with high morbidity and mortality, which can be complicated by long-term post-thrombotic syndrome (PTS). Pharmaco mechanical thrombolysis (PMT) is an innovative endovascular technique involving in situ fibrinolysis of the thrombus in the acute phase of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iliofemoral Venous Thrombosis
- What is being tested?
- pharmaco mechanical thrombolysis
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2026to 1 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients who agreed to participate in the study and gave oral consent.
- Patient affiliated to a social security scheme
- Iliac and/or common femoral venous thrombosis
- Recent thrombosis less than or equal to 14 days since qualifying imaging or less than or equal to 21 days since onset of symptoms
- And at least 1 of the following criteria:
- Visual analog scale greater than or equal to 5 and/or
- Venous claudication and/or
- Increase in thigh circumference greater than or equal to 5% compared with contralateral thigh.
Who cannot join
- Patients with superficial femoral or popliteal venous thrombosis without involvement of the common femoral or iliac veins.
- Patients with isolated thrombosis of the inferior vena cava, without extension to the iliac veins.
- Thrombosis of inferior vena cava proximal to the renal veins.
- Minors, pregnant women, adults under guardianship.
- Chronic renal failure with creatinine clearance below 30ml/min according to Cockroft.
- Ischaemic phlebitis: proximal venous thrombosis associated with limb ischemia and impaired arterial flow.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Dr Olivier Espitia
Nantes, 44000
Olivier Espitia, dr, +33 2 40 08 33 55, olivier.espitia@chu-nantes.fr
About this study
Official title: Prospective Randomised Multicentre Medico-economic Evaluation of Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
- Iliofemoral DVTs (IF DVTs) are vascular disorders associated with high morbidity and mortality, which can be complicated by long-term post-thrombotic syndrome (PTS).
- Pharmaco mechanical thrombolysis (PMT) is an innovative endovascular technique involving in situ fibrinolysis of the thrombus in the acute phase of thrombosis, followed by mechanical extraction by fragmenting the thrombus.
- The American ATTRACT study showed that management by catheter-directed thrombolysis and/or PMT in the acute phase is safe and effective at 2 years in a subgroup of DVTif compared with anticoagulation (18% moderate or severe SPT with thrombolysis vs. 28% without thrombolysis).
- PMT-DVT will be the first study to assess the medium (30 months) and long-term (60 months) efficacy of PMT in the French context, using data from the French National Health Data System.
Read the detailed description
Patients with acute iliofemoral thrombosis will be included in the study after consent. They will be randomized to pharmaco-mechanical thrombolysis combined with anticoagulant therapy with direct oral anticoagulant versus direct anticoagulant therapy alone. They will be monitored, and patients in the anticoagulation-only group may undergo stenting angioplasty in the chronic phase if they present a moderate post-thrombotic syndrome or venous claudication. At the end of 30 months, a medico-economic analysis will be carried out.
- Conditions
- Iliofemoral Venous Thrombosis
- Being tested
- pharmaco mechanical thrombolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaco mechanical thrombolysisDevice
arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants
| Study group | Role | What they receive |
|---|---|---|
| pharmaco mechanical thrombolysis | Experimental | thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants Receives: Device: pharmaco mechanical thrombolysis |
| oral anticoagulant alone | Active comparator | a reference treatment arm for patients receiving direct oral anticoagulant alone and stenting angioplasty in case of venous claudication or moderate post-thrombotic syndrome six months after the initial thrombosis. Receives: Device: pharmaco mechanical thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility analysis
Cost-utility analysis of the economic efficiency of the PMT strategy compared with the anticoagulation strategy for the treatment of DVT from a collective perspective and a 30-month time horizon
Measured: 30 month
Secondary outcomes (11)
Number of patients with Villalta score greater than or equal to 10
Number of patients with Villalta score greater than or equal to 10
Measured: 30 month
Number of patients with Villalta score greater than or equal to 15, or presence of ulceration
Number of patients with Villalta score greater than or equal to 15, or presence of ulceration
Measured: 30 month
Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria
Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria
Measured: 1, 30 and 60 month
Number of patients with pain greater than or equal to 7 as assessed by the visual analog scale, or the presence of venous claudication, or lower-limb edema with a circumference greater than 20% of the contralateral leg, or failure to return to work.
Number of patients with pain greater than or equal to 7 as assessed by the visual analog scale, or the presence of venous claudication, or lower-limb edema with a circumference greater than 20% of the contralateral leg, or failure to return to work.
Measured: 1 month
VEIN-QOL
overall assessment by questionnaire
Measured: 1,30 and 60 month
CIVIQ 20
score 0 to 100
Measured: 1,30 and 60 month
SF36 scores
score 0 to 100
Measured: 1,30 and 60 month
Number of patients with onset of venous claudication
Number of patients with onset of venous claudication
Measured: 30 month
Number of patients with a trophic disorder, assessed by clinical examination
Number of patients with a trophic disorder, assessed by clinical examination
Measured: 60 month
Incremental cost-utility ratio of MPT compared with anticoagulation strategy
Incremental cost-utility ratio of MPT compared with anticoagulation strategy
Measured: 60 month
Net financial impact over 5 years of TPM distribution
Net financial impact over 5 years of TPM distribution
Measured: 60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start20 May 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliofemoral Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472518
- Sponsor's protocol ID
- RC22_0472
- Acronym
- PMT-DVT
- Status last verified
- May 2026
- First submitted
- 2 Apr 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Multicentre Medico-economic Evaluation of Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
- ClinicalTrials.gov ID
- NCT06472518
- Acronym / sponsor ID
- PMT-DVT / RC22_0472
- Conditions
- Iliofemoral Venous Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 25 Jun 2024 (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.
- Iliofemoral DVTs (IF DVTs) are vascular disorders associated with high morbidity and mortality, which can be complicated by long-term post-thrombotic syndrome (PTS).
- Pharmaco mechanical thrombolysis (PMT) is an innovative endovascular technique involving in situ fibrinolysis of the thrombus in the acute phase of thrombosis, followed by mechanical extraction by fragmenting the thrombus.
- The American ATTRACT study showed that management by catheter-directed thrombolysis and/or PMT in the acute phase is safe and effective at 2 years in a subgroup of DVTif compared with anticoagulation (18% moderate or severe SPT with thrombolysis vs. 28% without thrombolysis).
- PMT-DVT will be the first study to assess the medium (30 months) and long-term (60 months) efficacy of PMT in the French context, using data from the French National Health Data System.
Detailed description
Patients with acute iliofemoral thrombosis will be included in the study after consent. They will be randomized to pharmaco-mechanical thrombolysis combined with anticoagulant therapy with direct oral anticoagulant versus direct anticoagulant therapy alone. They will be monitored, and patients in the anticoagulation-only group may undergo stenting angioplasty in the chronic phase if they present a moderate post-thrombotic syndrome or venous claudication. At the end of 30 months, a medico-economic analysis will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pharmaco mechanical thrombolysis | Experimental | Device: pharmaco mechanical thrombolysisthrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants |
| oral anticoagulant alone | Active comparator | Device: pharmaco mechanical thrombolysisa reference treatment arm for patients receiving direct oral anticoagulant alone and stenting angioplasty in case of venous claudication or moderate post-thrombotic syndrome six months after the initial thrombosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who agreed to participate in the study and gave oral consent.
- Patient affiliated to a social security scheme
- Iliac and/or common femoral venous thrombosis
- Recent thrombosis less than or equal to 14 days since qualifying imaging or less than or equal to 21 days since onset of symptoms
- Visual analog scale greater than or equal to 5 and/or
Key exclusion criteria (6 listed)
- Patients with superficial femoral or popliteal venous thrombosis without involvement of the common femoral or iliac veins.
- Patients with isolated thrombosis of the inferior vena cava, without extension to the iliac veins.
- Thrombosis of inferior vena cava proximal to the renal veins.
- Minors, pregnant women, adults under guardianship.
- Chronic renal failure with creatinine clearance below 30ml/min according to Cockroft.
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 |
|---|---|---|
| pharmaco mechanical thrombolysisarm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants | Device | oral anticoagulant alone, pharmaco mechanical thrombolysis |
Primary outcome
Cost-utility analysis
Time frame: 30 month
Cost-utility analysis of the economic efficiency of the PMT strategy compared with the anticoagulation strategy for the treatment of DVT from a collective perspective and a 30-month time horizon
11 secondary outcomes
Number of patients with Villalta score greater than or equal to 10
Time frame: 30 month
Number of patients with Villalta score greater than or equal to 15, or presence of ulceration
Time frame: 30 month
Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria
Time frame: 1, 30 and 60 month
Number of patients with pain greater than or equal to 7 as assessed by the visual analog scale, or the presence of venous claudication, or lower-limb edema with a circumference greater than 20% of the contralateral leg, or failure to return to work.
Time frame: 1 month
VEIN-QOL
Time frame: 1,30 and 60 month
CIVIQ 20
Time frame: 1,30 and 60 month
SF36 scores
Time frame: 1,30 and 60 month
Number of patients with onset of venous claudication
Time frame: 30 month
Number of patients with a trophic disorder, assessed by clinical examination
Time frame: 60 month
Incremental cost-utility ratio of MPT compared with anticoagulation strategy
Time frame: 60 month
Net financial impact over 5 years of TPM distribution
Time frame: 60 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pharmaco mechanical thrombolysis in people with Iliofemoral Venous Thrombosis, run by Nantes University Hospital 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 May 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Espitia, Dr (02 40 08 33 55, olivier.espitia@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility analysis (time frame: 30 month). 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 26 May 2026.