Phase 3
N=217
ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial
Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00759681 ↗Enrolled (actual)
217
Serious AEs
24.9%
Results posted
Jan 2013
Primary outcome: Primary: Immediate Sealing Evidenced by no Bleeding on Clamp Release. — 65; 101 Treatment sites — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ArterX Surgical Sealant (Device); Gelfoam and Thrombin (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tenaxis Medical, Inc.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immediate Sealing Evidenced by no Bleeding on Clamp Release. |
65; 101 | 0.05 |
| PRIMARY Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response |
64; 51 | 0.05 |
Summary
This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels using synthetic vascular grafts or patches.
Eligibility Criteria
Inclusion Criteria
Subject must meet all of the following criteria to be eligible for treatment in the Study:
- The subject must be equal or greater than 18 years old.
- The subject must be scheduled for the surgical placement of a synthetic (i.e., PTFE/Dacron) vascular graft or patch for large vessel repair/arterial reconstruction/hemodialysis access/arteriotomy.
- The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
- The subject is willing and able to be contacted for the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
- The subject or guardian must provide written informed consent using a form that is reviewed and approved by the IRB.
Exclusion Criteria
Subjects will be excluded from the Study if any of the following criteria are met:
- The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
- The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusions.
- The subject is currently enrolled in this, or another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period. Note: Extended follow-up trials for products that were investigational but are currently commercially available are not considered investigational trials.
Data sourced from ClinicalTrials.gov (NCT00759681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.