Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341010
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-09-24
Brief Title:
The Role of Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis
Sponsor:
Abdelrahman Ibrahim Sayed Mohamed Abdalla
Organization:
Assiut University
Study Overview
Official Title:
The Role of Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The aim of this study is to evaluate the efficacy and safety of rheolytic thrombectomy in restoring venous patency DVT periprocedural complications and development of PTS after tratment of iliofemoral DVT
Detailed Description:
Deep venous thrombosis DVT is a common disease affecting approximately 01 of the world population1 The incidence of DVT steadily increases as the patient gets older One-third of patients with DVT may develop pulmonary embolism PE2 DVT can significantly influence the quality of life of patients and it represents an important clinical and economic disease burden on health-care systems
Over the years different options for DVT treatment have been introduced to restore patency save valve function and reduce the occurrence of post-thrombotic syndrome PTS
The conventional treatment of acute DVT aims to prevent thrombus propagation and to reduce the risks of PE and DVT recurrence5 However this treatment is ineffective at reducing thrombus burden and consequently does not prevent PTS Recent advances in catheter-based interventions have led to the development of a variety of minimally invasive endovascular strategies to remove venous thrombus
Lower-extremity DVT especially proximal or iliofemoral DVT has been demonstrated to confer the greatest risk for complications such as pulmonary embolism thrombosis recurrence and post- thrombotic syndrome Most practice guidelines recommend early clot removal for patients with iliofemoral DVT who have symptoms less than 14 days in duration good functional ability and acceptable life expectancy and who are at low risk for bleeding complications
Removal of clot can be achieved by using catheter-directed thrombolysis CDT or pharmacomechanicalUse of CDT is limited because of the lengthy procedurehospitalization time and intensive care unit ICU stays required for the procedure11 pharmacomechanical was developed to address the limitations of CDT by combining catheter-based and mechanical technology to fragment andor aspirate thrombus in addition to delivering a thrombolytic drug throughout the thrombus
Percutaneous rheolytic thrombectomy RT technique is highly effective at clearing thrombus which preserves venous valve function and prevents subsequent PTS The use of RT to treat DVT may reduce long-term morbidity in DVT patients by restoring the patency of the veins and preventing pulmonary embolism
Over the years different options for DVT treatment have been introduced to restore patency save valve function and reduce the occurrence of post-thrombotic syndrome PTS
The conventional treatment of acute DVT aims to prevent thrombus propagation and to reduce the risks of PE and DVT recurrence5 However this treatment is ineffective at reducing thrombus burden and consequently does not prevent PTS Recent advances in catheter-based interventions have led to the development of a variety of minimally invasive endovascular strategies to remove venous thrombus
Lower-extremity DVT especially proximal or iliofemoral DVT has been demonstrated to confer the greatest risk for complications such as pulmonary embolism thrombosis recurrence and post- thrombotic syndrome Most practice guidelines recommend early clot removal for patients with iliofemoral DVT who have symptoms less than 14 days in duration good functional ability and acceptable life expectancy and who are at low risk for bleeding complications
Removal of clot can be achieved by using catheter-directed thrombolysis CDT or pharmacomechanicalUse of CDT is limited because of the lengthy procedurehospitalization time and intensive care unit ICU stays required for the procedure11 pharmacomechanical was developed to address the limitations of CDT by combining catheter-based and mechanical technology to fragment andor aspirate thrombus in addition to delivering a thrombolytic drug throughout the thrombus
Percutaneous rheolytic thrombectomy RT technique is highly effective at clearing thrombus which preserves venous valve function and prevents subsequent PTS The use of RT to treat DVT may reduce long-term morbidity in DVT patients by restoring the patency of the veins and preventing pulmonary embolism
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