The Role of Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis

Recruiting

• Conditions: Iliofemoral Deep Vein Thrombosis

• Registration Number: NCT06341010
• Lead Sponsor: Abdelrahman Ibrahim Sayed Mohamed Abdalla

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 0.1% of the world population.1 The incidence of DVT steadily increases as the patient gets older. One-third of patients with DVT may develop pulmonary embolism (PE)2. 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 pharmacomechanical.Use of CDT is limited because of the lengthy procedure/hospitalization 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 and/or 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 Timeline

• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-02
• Study Start: 2024-05-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-01-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Acute IF DVT

life expectancy more than 1 year

Exclusion Criteria

• Recurrence of DVT Chronic DVT The catheter cannot be used in vessels smaller than 6mm. Patients have contraindications for endovascular procedures Patients cannot tolerate contrast media In patients with lesions that cannot be accessed with the guide wire Pregnancy History of pelvic surgery with left iliac vein injury or pelvic radioactive therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success	Immediately intraoperative	Thrombus removal and restoration of the venous flow intraoperatively

Secondary Outcome Measures

Name	Time	Method
Incidence of PTS	Two years	Incidence of post-thrombotic syndrome within 2 years after intervention

Trial Locations

Locations (1)

Asyut university; 🇪🇬 Asyūţ, Egypt