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| Name | Class |
|---|---|
| CryoLife, Inc. | INDUSTRY |
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Compare the HeRO Vascular Access Device to a conventional ePTFE graft.
The purpose of this study is to compare the HeRO Vascular Access Device to a conventional ePTFE graft. It is hypothesized that HeRO patency will be comparable to the conventional ePTFE graft control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control graft | Active Comparator | Conventional ePTFE hemodialysis graft |
|
| HeRO Vascular Access Device | Experimental | HeRO Vascular Access Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeRO Vascular Access Device | Device | HeRO Vascular Access Device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Primary Patency | Primary patency was defined as the interval of time from access placement until any intervention designed to maintain or reestablish patency, access thrombosis, or the time of measurement of patency. | 6 months, 12 months |
| Percentage of Patients With Assisted Primary Patency | Assisted primary patency was defined as the interval of time from access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (i.e., surgical or endovascular interventions) designed to maintain the functionality of a patent access. | 6 months, 12 months |
| Percentage of Patients With Secondary Patency | Secondary patency was defined as the interval of time from access placement until access abandonment, thrombosis, or the time of patency measurements including intervening surgical or endovascular interventions designed to reestablish functionality in a thrombosed access. | 12 months |
| Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Serious adverse events were defined as events that required hospitalization ≥24 hours, prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, were considered life-threatening, or resulted in death. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of Dialysis | Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Glickman, MD | Sentara Heart Hospital, Norfolk, VA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Medical Center | Los Angeles | California | 90057 | United States | ||
| University of Miami/Cedars Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24428351 | Result | Nassar GM, Glickman MH, McLafferty RB, Croston JK, Zarge JI, Katzman HE, Peden EK, Lawson JH, Martinez JM, Thackeray L. A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients. Semin Dial. 2014 May-Jun;27(3):310-8. doi: 10.1111/sdi.12173. Epub 2014 Jan 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Graft | Conventional ePTFE hemodialysis graft |
| FG001 | HeRO Vascular Access Device | HeRO Vascular Access Device: HeRO Vascular Access Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Conventional ePTFE hemodialysis graft |
| Device |
Conventional ePTFE hemodialysis graft |
|
| Miami |
| Florida |
| 33125 |
| United States |
| St. Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| Southern Illinois Unversity | Springfield | Illinois | 62702 | United States |
| Holy Cross Hospital | Rockville | Maryland | 20852 | United States |
| North Memorial Medical Center | Robbinsdale | Minnesota | 55422 | United States |
| Duke Medical Center | Durham | North Carolina | 27710 | United States |
| Seton/Brackenridge Hospitals | Austin | Texas | 78703 | United States |
| Baylor Medical Center/Methodist Hospital | Houston | Texas | 77030 | United States |
| Baptist Medical Center | San Antonio | Texas | 78205 | United States |
| Sentara Heart Hospital | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Conventional Arteriovenous ePTFE Graft Recipients |
| BG001 | HeRO Group | HeRO Graft Recipients |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| History of Coronary artery disease | Number | participants |
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| History of Diabetes mellitus | Number | participants |
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| History of Hypertension | Number | participants |
| ||||||||||||||||
| Access History | Number | participants |
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| 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 | Percentage of Patients With Primary Patency | Primary patency was defined as the interval of time from access placement until any intervention designed to maintain or reestablish patency, access thrombosis, or the time of measurement of patency. | The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date. Note: Of the 52 subjects randomized to the HeRO Graft, 50 subjects were successfully implanted. Two implants were abandoned. | Posted | Number | 95% Confidence Interval | percentage of participants patent | 6 months, 12 months |
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| Primary | Percentage of Patients With Assisted Primary Patency | Assisted primary patency was defined as the interval of time from access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (i.e., surgical or endovascular interventions) designed to maintain the functionality of a patent access. | The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date. | Posted | Number | 95% Confidence Interval | percentage of participants patent | 6 months, 12 months |
|
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| Primary | Percentage of Patients With Secondary Patency | Secondary patency was defined as the interval of time from access placement until access abandonment, thrombosis, or the time of patency measurements including intervening surgical or endovascular interventions designed to reestablish functionality in a thrombosed access. | The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date. | Posted | Number | 95% Confidence Interval | percentage of participants patent | 12 months |
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| Primary | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Serious adverse events were defined as events that required hospitalization ≥24 hours, prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, were considered life-threatening, or resulted in death. | Posted | Number | participants | 12 months |
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| Secondary | Adequacy of Dialysis | Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water | The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date. | Posted | Mean | Standard Deviation | Kt/V | 12 months |
|
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1 year
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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 | Control Group | Conventional Arteriovenous ePTFE Graft Recipients | 5 | 20 | 4 | 20 | ||
| EG001 | HeRO Group | HeRO Graft Recipients | 19 | 52 | 5 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding, hemorrhage or hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Death | General disorders | Non-systematic Assessment |
| ||
| Device technical failure | General disorders | Non-systematic Assessment |
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| Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Heart failure | Cardiac disorders | Non-systematic Assessment |
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| Infection (non-BSI) | Infections and infestations | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| Site pain | General disorders | Non-systematic Assessment |
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| Trauma to major veins, arteries, nerves | Nervous system disorders | Non-systematic Assessment |
| ||
| Steal syndrome | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Atrial Clot | Cardiac disorders | Non-systematic Assessment |
| ||
| Hypertension with fever | Vascular disorders | Non-systematic Assessment |
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| non-sustained mild and ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
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| cardiogenic shock | Cardiac disorders | Non-systematic Assessment |
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| hypoxia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| hypoxemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| elevated white blood cell count | Blood and lymphatic system disorders | Non-systematic Assessment |
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| symptomatic central venous stenosis | Vascular disorders | Non-systematic Assessment |
|
Due to slow enrollment and early termination of the study, a shortcoming of this trial, a final conclusion on equivalency between the HeRO Graft and conventional AV graft could not be firmly established.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George M. Nassar M.D. | Houston Methodist Hospital | 713-790-1963 | georgemnassar@gmail.com |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| No |
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| No |
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| No |
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| Re do Access |
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| 12 Months |
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