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

August 8, 2024 updated by: Abdelrahman Ibrahim Sayed Mohamed Abdalla
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients presented with acute iliofemoral DVT

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Immediately intraoperative
Thrombus removal and restoration of the venous flow intraoperatively
Immediately intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of PTS
Time Frame: Two years
Incidence of post-thrombotic syndrome within 2 years after intervention
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abdelrahman Ibrahim Sayed Mohamed Abdalla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Role of Angiojet Rheolytic

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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