ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial (StEPS)
This study has been completed.
Sponsor:
Tenaxis Medical, Inc.
Information provided by (Responsible Party):
Tenaxis Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00759681
First received: September 23, 2008
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vascular Disease |
Device: ArterX Surgical Sealant Device: Gelfoam and Thrombin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant. |
Resource links provided by NLM:
Further study details as provided by Tenaxis Medical, Inc.:
Primary Outcome Measures:
- Immediate Sealing Evidenced by no Bleeding on Clamp Release. [ Time Frame: Immediate at time of surgery ] [ Designated as safety issue: No ]The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery
- Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response [ Time Frame: Treatment through 6 weeks ] [ Designated as safety issue: Yes ]The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.
| Enrollment: | 217 |
| Study Start Date: | September 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control
Gelfoam and Thrombin
|
Device: Gelfoam and Thrombin
Apply at the suture site.
Other Name: Gelfoam Plus
|
|
Experimental: Investigational Device
ArterX Surgical Sealant
|
Device: ArterX Surgical Sealant
Apply at the suture site.
Other Name: ArterX Vascular Sealant
|
Detailed Description:
To evaluate, during open vascular surgery, the safety and effectiveness of the ArterX™ Vascular Sealant when applied prophylactically. Application will be at synthetic vascular graft or patch to native vessel anastomosis prior to the restoration of full systemic circulation to achieve suture line sealing.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759681
Locations
| United States, South Carolina | |
| Greenville Memorial Hospital | |
| Greenville, South Carolina, United States, 29615 | |
Sponsors and Collaborators
Tenaxis Medical, Inc.
Investigators
| Principal Investigator: | David Cull, MD | Greenville Hospital System |
More Information
Publications:
| Responsible Party: | Tenaxis Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00759681 History of Changes |
| Other Study ID Numbers: | CLN-004, IDE Number - G070211 |
| Study First Received: | September 23, 2008 |
| Results First Received: | October 31, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tenaxis Medical, Inc.:
|
Arterial Surgery Open vascular Surgery Sealant |
Additional relevant MeSH terms:
|
Vascular Diseases Cardiovascular Diseases Thrombin Gelatin Sponge, Absorbable Hemostatics |
Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013