Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT06051032
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2023-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy Vs. Thromboaspiration.
Sponsor:
Instituto de Investigacion Sanitaria La Fe
Organization:
Study Overview
Official Title:
Prospective Randomized Comparative Study on the Incidence of Pulmonary Emboembolism (PE) After Endovascular Treatment of Thrombosed Dialysis Arterio Venous Fistulas (AVF): Balloon Thrombectomy Versus Thromboaspiration Systems.
Status:
RECRUITING
Status Verified Date:
2025-01
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 goal of this multicentric clinical trial is to compare the incidence of pulmonary thromboembolism (PTE), assessed through AngioCT, in the endovascular treatment of acute thrombosis in native and prosthetic arteriovenous fistulas (AVF). The main questions it aims to answer are:
* What is the difference in the incidence of pulmonary thromboembolism (PTE) assessed by AngioCT in endovascular treatment of acute thrombosis of native and prosthetic arteriovenous fistulas using balloon thrombectomy versus thromboaspiration systems?
* What is the primary patency rate of arteriovenous fistulas treated with balloon thrombectomy versus thromboaspiration systems?
* What is the clinical success rate in the treatment of arteriovenous fistulas using balloon thrombectomy compared to thromboaspiration systems?
* What are the costs associated with the different thrombectomy techniques in the treatment of arteriovenous fistulas?
Participants will be underwent to balloon thrombectomy versus thromboaspiration systems.
Researchers will compare the patients treated with balloon thrombectomy and thromboaspiration systems to see if the incidence of PE is comparable and to evaluate the primary and secondary patency rates of both thrombectomy techniques, the clinical technical success rate, and the costs associated with each technique.
* What is the difference in the incidence of pulmonary thromboembolism (PTE) assessed by AngioCT in endovascular treatment of acute thrombosis of native and prosthetic arteriovenous fistulas using balloon thrombectomy versus thromboaspiration systems?
* What is the primary patency rate of arteriovenous fistulas treated with balloon thrombectomy versus thromboaspiration systems?
* What is the clinical success rate in the treatment of arteriovenous fistulas using balloon thrombectomy compared to thromboaspiration systems?
* What are the costs associated with the different thrombectomy techniques in the treatment of arteriovenous fistulas?
Participants will be underwent to balloon thrombectomy versus thromboaspiration systems.
Researchers will compare the patients treated with balloon thrombectomy and thromboaspiration systems to see if the incidence of PE is comparable and to evaluate the primary and secondary patency rates of both thrombectomy techniques, the clinical technical success rate, and the costs associated with each technique.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: