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To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE® Hybrid Vascular Graft | Active Comparator | GORE® Hybrid Vascular Graft |
|
| Non-heparin bonded synthetic graft | Other | Non-heparin bonded synthetic graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® Hybrid Vascular Graft | Device |
| ||
| Non-heparin bonded synthetic graft |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points | Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM. | 14 days after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack | New Jersey | 07601 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE® Hybrid Vascular Graft | Subjects Randomized to the GORE® Hybrid Vascular Graft |
| FG001 | Non-heparin Bonded Synthetic Graft | Subjects Randomized to the Non-heparin bonded synthetic graft |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE® Hybrid Vascular Graft | GORE® Hybrid Vascular Graft> > GORE® Hybrid Vascular Graft |
| BG001 | Non-heparin Bonded Synthetic Graft | Non-heparin bonded synthetic graft> > Non-heparin bonded synthetic graft |
| 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 | Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points | Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM. | In the GORE® Hybrid Vascular Graft Group 19 out of 23 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis. In the Non-heparin bonded synthetic graft Group 16 out of 19 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis. | Posted | Count of Participants | Participants | 14 days after index procedure |
|
2 years, 3 months
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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 | Hybrid Vascular Graft (Test) | Hybrid Vascular Graft (Test) | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unsteady gait | General disorders | MedDRA Version 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral edema | General disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzy Palmer, CCRP | W.L. Gore and Associates, Inc. | 928-864-3670 | supalmer@wlgore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2015 | Jan 18, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 6, 2014 | Jan 18, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Device |
|
| Charlotte |
| North Carolina |
| 28207 |
| United States |
| Durham | North Carolina | 27710 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Non-heparin Bonded Synthetic Graft |
Non-heparin bonded synthetic graft > > Non-heparin bonded synthetic graft |
|
|
| 23 |
| 6 |
| 23 |
| 4 |
| 23 |
| EG001 | Non-Heparin Synthetic Graft (Control) | Non-Heparin Synthetic Graft (Control) | 1 | 19 | 5 | 19 | 8 | 19 |
| Weakness | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Cellulitis of legs | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Graft infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Sigmoid diverticulitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Motor vehicle accident | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pleural effusion recurrent | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Venous pressure increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Numbness in hand | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Steal syndrome | Vascular disorders | MedDRA Version 20.0 | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |