An interventional study of GORE® Hybrid Vascular Graft and Non-heparin bonded synthetic graft in End Stage Renal Disease, sponsored by W.L.Gore & Associates. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by W.L.Gore & Associates · Not applicable, Interventional, and Basic science
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).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 42 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
GORE® Hybrid Vascular Graft
Device: GORE® Hybrid Vascular Graft
Non-heparin bonded synthetic graft
Device: Non-heparin bonded synthetic graft
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.
Time frame: 14 days after index procedure
| Milestone | GORE® Hybrid Vascular Graft | Non-heparin Bonded Synthetic Graft |
|---|---|---|
| Started | 23 | 19 |
| Completed | 4 | 5 |
| Not completed | 19 | 14 |
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.
| Participants | GORE® Hybrid Vascular Graft | Non-heparin Bonded Synthetic Graft |
|---|---|---|
| Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points | 3 | 2 |
Collected over 2 years, 3 months. Non-serious events are listed at a 5.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hybrid Vascular Graft (Test) | 1/23 (4.3%) | 6/23 (26.1%) | 4/23 (17.4%) |
| Non-Heparin Synthetic Graft (Control) | 1/19 (5.3%) | 5/19 (26.3%) | 8/19 (42.1%) |
| Event | Hybrid Vascular Graft (Test) | Non-Heparin Synthetic Graft (Control) |
|---|---|---|
| Cellulitis of legsInfections and infestations | 0/23 | 1/19 |
| Septic shockInfections and infestations | 0/23 | 1/19 |
| Sigmoid diverticulitisInfections and infestations | 0/23 | 1/19 |
| Urinary tract infectionInfections and infestations | 0/23 | 1/19 |
| Muscle weakness upper limbMusculoskeletal and connective tissue disorders | 0/23 | 1/19 |
| SeizureNervous system disorders | 0/23 | 1/19 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/23 | 1/19 |
| Pleural effusion recurrentRespiratory, thoracic and mediastinal disorders | 0/23 | 1/19 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/23 | 1/19 |
| Unsteady gaitGeneral disorders | 1/23 | 0/19 |
| Event | Hybrid Vascular Graft (Test) | Non-Heparin Synthetic Graft (Control) |
|---|---|---|
| Steal syndromeVascular disorders | 3/23 | 2/19 |
| Peripheral edemaGeneral disorders | 0/23 | 1/19 |
| Arteriovenous graft thrombosisInjury, poisoning and procedural complications | 1/23 | 1/19 |
| Venous pressure increasedInvestigations | 0/23 | 1/19 |
| Numbness in handNervous system disorders | 0/23 | 1/19 |
| COPD exacerbationRespiratory, thoracic and mediastinal disorders | 0/23 | 1/19 |
| WheezingRespiratory, thoracic and mediastinal disorders | 0/23 | 1/19 |
| BlisterSkin and subcutaneous tissue disorders | 0/23 | 1/19 |
| HematomaVascular disorders | 0/23 | 1/19 |
| Age, Continuous(years) | GORE® Hybrid Vascular Graft | Non-heparin Bonded Synthetic Graft | Total |
|---|---|---|---|
| Mean | 61.8 ± 12.9 | 58.7 ± 12.2 | 60.4 ± 12.5 |
| Sex: Female, Male(Participants) | GORE® Hybrid Vascular Graft | Non-heparin Bonded Synthetic Graft | Total |
|---|---|---|---|
| Female | 14 | 9 | 23 |
| Male | 9 | 10 | 19 |
| Ethnicity (NIH/OMB)(Participants) | GORE® Hybrid Vascular Graft | Non-heparin Bonded Synthetic Graft | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 23 | 19 | 42 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | GORE® Hybrid Vascular Graft | Non-heparin Bonded Synthetic Graft | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 19 | 15 | 34 |
| White | 4 | 4 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | GORE® Hybrid Vascular Graft | Non-heparin Bonded Synthetic Graft | Total |
|---|---|---|---|
| United States | 23 | 19 | 42 |
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