Vascular Disease
Conditions
Keywords
Arterial Surgery, Open vascular Surgery, Sealant
Brief 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.
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.
Interventions
DEVICEArterX Surgical Sealant
Apply at the suture site.
DEVICEGelfoam and Thrombin
Apply at the suture site.
Sponsors
Tenaxis Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject must meet all of the following criteria to be eligible for treatment in the Study: 1. The subject must be equal or greater than 18 years old. 2. 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. 3. The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure. 4. The subject is willing and able to be contacted for the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days). 5. 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: 1. The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products. 2. The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusions. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Sealing Evidenced by no Bleeding on Clamp Release. | Immediate at time of surgery | 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 | Treatment through 6 weeks | The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks. |
Countries
United States
Participant flow
Recruitment details
A total of 217 subjects (110 ArterX, 107 Control) were treated at eleven (11) participating investigational centers. Randomized subjects were treated from 10/08 to 12/09. The last follow-up visit was conducted in 03/10.
Participants by arm
| Arm | Count |
|---|---|
| Control Control Treatment: Gelfoam and Thrombin | 107 |
| Investigational Device Investigational Treatment: ArterX Surgical Sealant | 110 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 5 |
| Overall Study | Lost to Follow-up | 8 | 5 |
Baseline characteristics
| Characteristic | Control | Investigational Device | Total |
|---|---|---|---|
| Age Continuous | 65.7 years STANDARD_DEVIATION 12.3 | 66.2 years STANDARD_DEVIATION 12.3 | 66.0 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 107 participants | 110 participants | 217 participants |
| Sex: Female, Male Female | 37 Participants | 41 Participants | 78 Participants |
| Sex: Female, Male Male | 70 Participants | 69 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 106 | 9 / 108 |
| serious Total, serious adverse events | 26 / 107 | 28 / 110 |
Outcome results
Primary
Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response
The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.
Time frame: Treatment through 6 weeks
Population: Based on ITT population for primary safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Treatment | Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response | 64 participants |
| Investigational Device | Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response | 51 participants |
Comparison: The mean difference is equivalent to the proportion of Investigational Device patients minus the proportion of Control patients experiencing any instance of significant bleeding, neurological deficit or immune/inflammatory allergic response.p-value: 0.05Exact binomial confidence limit
Primary
Immediate Sealing Evidenced by no Bleeding on Clamp Release.
The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery
Time frame: Immediate at time of surgery
Population: Treatment sites were the unit of measure based on ITT for effectiveness outcomes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Treatment | Immediate Sealing Evidenced by no Bleeding on Clamp Release. | 65 Treatment sites |
| Investigational Device | Immediate Sealing Evidenced by no Bleeding on Clamp Release. | 101 Treatment sites |
Comparison: Effectiveness was evaluated using a superiority hypothesis, comparing treatment sites with regards to the proportion achieving immediate suture line sealing between the groups. Effectiveness was based on a two-tailed, 0.05 hypothesis test, with a minimum effect size set at 10%. The mean difference in the proportion of sites achieving immediate suture line sealing was compared between the Control and Investigation Device groups.p-value: 0.0595% CI: [0.103, 0.314]Exact binomial confidence limit