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| ID | Type | Description | Link |
|---|---|---|---|
| IDE Number - G070211 |
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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.
To evaluate, during open vascular surgery, the safety and effectiveness of the ArterXâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Gelfoam and Thrombin |
|
| Investigational Device | Experimental | ArterX Surgical Sealant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ArterX Surgical Sealant | Device | Apply at the suture site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediate at time of surgery |
| 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. | Treatment through 6 weeks |
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Inclusion Criteria:
Subject must meet all of the following criteria to be eligible for treatment in the Study:
Exclusion Criteria:
Subjects will be excluded from the Study if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| David Cull, MD | Greenville Hospital System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenville Memorial Hospital | Greenville | South Carolina | 29615 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22939276 | Result | Stone WM, Cull DL, Money SR. A randomized prospective multicenter trial of a novel vascular sealant. Ann Vasc Surg. 2012 Nov;26(8):1077-84. doi: 10.1016/j.avsg.2012.02.013. Epub 2012 Aug 29. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control: Gelfoam and Thrombin | Gelfoam PlusTM is used to seal suture lines of arterial grafts or patches made from PTFE and Dacron. Gelfoam is a sterile compressed sponge and Thrombin is the last enzyme in the clotting cascade. |
| FG001 | Investigational Device: ArterX Surgical Sealant | ArterX is a two-component sealant provided in a double barreled syringe. The main components are bovine serum albumin and a polyaldehyde formed from polymerized glutaraldehyde. The solutions are dispensed through a double plunger, mixing the two components in a 1:1 ratio by passing them through a specially designed mixing tip, delivering up to 2 ml volume of each component. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control Treatment: Gelfoam and Thrombin |
| BG001 | Investigational Device | Investigational Treatment: ArterX Surgical Sealant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Treatment sites were the unit of measure based on ITT for effectiveness outcomes. | Posted | Number | Treatment sites | Immediate at time of surgery | Treatment sites | Participants |
|
Adverse events were collected through 3 months post surgery.
Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2. Gelfoam and Thrombin | Gelfoam and Thrombin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Significant Bleeding | Surgical and medical procedures |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious Infections | Infections and infestations | For Other Adverse Events/non-serious infections, the denominator for the Control and Investigational groups are less than the total subjects at risk since 3 total subjects were not evaluated for non-serious infections since due to early termination. |
There were no significant trial limitations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Cull, MD | Greenville Memorial Hospital | 864-455-9825 |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005781 | Gelatin Sponge, Absorbable |
| ID | Term |
|---|---|
| D015503 | Surgical Sponges |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Gelfoam and Thrombin | Device | Apply at the suture site. |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
| Treatment sites |
|
|
|
| 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. | Based on ITT population for primary safety analysis. | Posted | Number | participants | Treatment through 6 weeks |
|
|
|
|
| 26 |
| 107 |
| 11 |
| 106 |
| EG001 | 1. ArterX Surgical Sealant | ArterX Surgical Sealant | 28 | 110 | 9 | 108 |
| Infection | Infections and infestations |
|
| Neurological Deficit | Nervous system disorders |
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| Immune/Inflammatory Allergic Response | Immune system disorders |
|
| Death | Investigations |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Thrombosis/Thromboembolism | Vascular disorders | Systematic Assessment |
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| Ischemia | Vascular disorders | Systematic Assessment |
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| Respiratory Failure/Dysfunction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Steal Syndrome | Vascular disorders | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
|
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| Yes |
| Non-Inferiority or Equivalence |
Safety was evaluated using non-inferiority hypothesis evaluating the proportion of cases with any instance of sign. bleeding, neurological deficit or immune/inflammatory allergic response. Safety based on one-tailed, 0.05 alpha, with equivalence limit set at 15%. |