Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-02
Brief Title:
Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMT-DVT
Brief 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 thrombosis followed by mechanical extraction by fragmenting the thrombus
The American ATTRACT study showed that management by catheter-directed thrombolysis andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None