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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P240004 / PAS001 |
| Date Original Protocol Accepted |
07/18/2025
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| Date Current Protocol Accepted |
07/18/2025
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| Study Name |
EndoForce Post-Approval Study
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| Device Name |
EndoForce Connector for Endovascular Venous Anastomosis
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| Clinical Trial Number(s) |
NCT02532621
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Study Design and Objective(s) The purpose of this study is to collect post-approval, longer-term, real-world safety and effectiveness data for the use of the Phraxis EndoForce Connector for Endovascular Venous Anastomosis (EndoForce System) through 2 years post-implantation. The study is a prospective, multicenter, open-label study.
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| Study Population |
Patients with End Stage Renal Disease who have a planned arteriovenous graft implant procedure for hemodialysis access and who meet the study enrollment criteria.
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| Sample Size |
Number of subjects: 150
Number of sites: 20
Sites location: USA
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| Key Study Endpoints |
Study Endpoints Assessments will be made at 2-weeks, 1, 3, 6, 12, 18 and 24 months following the index procedure. For the purposes of study outcome evaluation, the index procedure is defined as arteriovenous graft (AVG) implantation using the EndoForce System. With a 50% 2-year survival rate for ESRD patients, it is anticipated that 2-year data will be available on approximately 75 subjects.
1. Safety will be assessed by reporting all device and/or procedure-related events and all major adverse events that reasonably suggest the involvement of the EndoForce and that require or result in any of the following: death, emergent surgery, events requiring hospitalization, events requiring percutaneous interventions, vascular access infection requiring treatment, significant bleeding, pseudoaneurysm and serious adverse events through the 2-year visit. EndoForce migration, inadequate seal and leakage will also be collected acutely and at each in-person follow-up visit and reported through the 2-year visit.
2. AVG Cumulative Patency: Defined as the percentage of subjects free from loss of access of the study graft for hemodialysis.
3. AVG Primary Patency: Defined as the percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency.
4. Number of AVG interventions until access abandonment or through study completion.
5. Acute Device Success: Defined as AV graft flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery.
NOTE: Outcome measures will be evaluated acutely (at the time of implant), at time of any AVG intervention, and at all planned study visits. The study AVG patency evaluation starts immediately after the index procedure is completed (e.g., subject leaves the surgery suite). This means that once the AVG is created, patency evaluation begins. The occurrence of acute thrombus and treatment thereof during the index procedure while the vascular access is being created does not trigger the loss of primary patency. Secondary outcome measures will be further evaluated by relatedness to the EndoForce device.
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| Follow-up Visits and Length of Follow-up |
Assessments will be made at 2-weeks, 1, 3, 6, 12, 18 and 24 months following the index procedure. The 1-month and 3-month follow-up will be phone visits, all other visits will be in-person.
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