Arteriovenous Access Grafts or Extra-anatomic and Infra-inguinal Grafts Clinical Trial
Official title:
A Prospective, Randomized, Multi-Center, Two Arm Study to Evaluate the Safety and Effectiveness of the Vascular Sealant System Compared With Gelfoam/Thrombin for Control of Anastomosis Suture Line Bleeding in Patients Undergoing Vascular Reconstructive Surgery With PTFE Grafts
Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared
with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients
undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including
extra-anatomic, infrainguinal bypass and arteriovenous (AV) access procedures).
Study Design: The study is a multi-center, prospective, randomized controlled clinical trial
that will compare two methods for treating anastomotic leakage (bleeding). All subjects (n
=151) will be randomized at a 3:1 ratio to receive either the investigational treatment
(Vascular Sealant) or the control treatment (Gelfoam/Thrombin). Up to two (2) treatment
sites may be evaluated for each subject. Subjects will be stratified by type of graft
procedure: AV access graft or extra-anatomic and infra-inguinal graft. A minimum of 60
patients, and a maximum of 91 patients, will be enrolled in each stratum. Treatment
randomization will be blocked by center and type of graft procedure (e.g., bypass or AV
grafts). All subjects will undergo preoperative screening to determine eligibility and will
be evaluated intraoperatively, at discharge or within 7 days of surgery, and 30 days
post-procedure to monitor for hematologic disturbances, hemorrhagic events, wound
complications and other potential acute post-operative adverse events.
Up to ten (10) investigational sites will participate in the study. Enrollment is expected
to take approximately 8 months for an anticipated duration of the clinical investigation of
approximately 9 to 10 months.
The primary objective of this trial is to demonstrate non-inferiority of the Vascular
Sealant to Gelfoam/Thrombin when used to seal anastomotic suture lines in patients
undergoing placement of PTFE vascular grafts (including extra-anatomic, infrainguinal bypass
and arteriovenous access procedures).
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment