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A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ellipsys Vascular Access Catheter | Experimental | ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ellipsys Vascular Access Catheter | Device | A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae. |
| Measure | Description | Time Frame |
|---|---|---|
| Maturation Success Rate at 90 Days | Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population. | 90 days |
| Number of Participants With Device-related Serious Adverse Events | The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Access Systems That Successfully Created an AVF | Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment | 90 days |
| Percent of Access Sites With Clinical Patency at Discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First AVF Cannulation | Time to AVF cannulation was defined as the elapsed time to the first use of access site (from the date of the study procedure). | 90 days |
| Catheter Utilization | Catheter utilization was defined as the total number of days a catheter was used before access site maturation per subject. The start date was either 1) the date of the study procedure, for subjects who already had a dialysis catheter in place or 2) the date placed, if during the study. The end date was either 1) the date the catheter was removed or 2) the 90 day visit, if the catheter was still in place. |
Inclusion Criteria:
Patients were eligible for enrollment into the study if they met the following criteria:
Patients ≥ 18 years of age and ≤ 80 years of age
Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)
Life expectancy of at least one year, per the investigator's opinion
Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment
Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment
Adequate quality vein based on pre-operative assessment
Adequate quality radial artery based on pre-operative assessment
a. Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site
Adequate collateral arterial perfusion
No clinical evidence of subclavian artery stenosis on the ipsilateral side.
Radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
Patient was able to provide written informed consent
Able to travel to enrolling institution for follow-up examinations
Able and willing to follow a daily aspirin and/or other anti-coagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant, see exclusion criteria 15)
Exclusion Criteria:
Patients were excluded if any of the following was true:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Hull, MD | Richmond Vascular Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Vascular Center | Tempe | Arizona | 85281 | United States | ||
| BNMG San Diego Vascular Access Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ellipsys Vascular Access Catheter | ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ellipsys Vascular Access Catheter | ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae. |
| 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 | Maturation Success Rate at 90 Days | Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population. | Posted | Count of Participants | Participants | 90 days |
|
90 days
Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
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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 | Ellipsys Vascular Access Catheter | ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac serious adverse events | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye, ear nonserious events | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gene Reu EVP and General Manager | Avenu Medical | 9492762483 | greu@avenumedical.com |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D001164 | Arteriovenous Fistula |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Percent of access sites that demonstrated physical exam patency through clinic discharge
| 90 days |
| Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days | Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation | 90 days |
| Percent of Access Sites That Achieved or Maintained Maturation at 90 Days | Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency. | 90 days |
| Percent of Access Sites That Achieved Maturation Without Intervention | Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation | 90 days |
| Percent of Access Sites That Were Patent Following Intervention | Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency | 90 days |
| Percent of Access Sites That Achieved Patency Without Intervention | Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site | 90 days |
| Intervention Rate | Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site | 90 days |
| Transposition Rate | Percent of subjects who required one or more surgical transpositions performed to facilitate needle access | 90 days |
| 90 days |
| Target Vessel Location | Anatomic location of matured target vessel | 90 days |
| San Diego |
| California |
| 92115 |
| United States |
| Dallas Nephrology Associates | Plano | Texas | 75093 | United States |
| San Antonio Kidney Disease Center | San Antonio | Texas | 78016 | United States |
| Richmond Vascular Center | North Chesterfield | Virginia | 23236 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Device-related Serious Adverse Events | The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Percent of Participants With Access Systems That Successfully Created an AVF | Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Percent of Access Sites With Clinical Patency at Discharge | Percent of access sites that demonstrated physical exam patency through clinic discharge | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days | Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation | The analysis population analyzed (65) is a subset of of the overall number of participants analyzed (103) due to not all participants being on dialysis an requiring 2 needle cannulation by the 90 day outcome measure time frame | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Percent of Access Sites That Achieved or Maintained Maturation at 90 Days | Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency. | The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Percent of Access Sites That Achieved Maturation Without Intervention | Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation | The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Percent of Access Sites That Were Patent Following Intervention | Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency | The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Percent of Access Sites That Achieved Patency Without Intervention | Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site | The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Intervention Rate | Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site | The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Transposition Rate | Percent of subjects who required one or more surgical transpositions performed to facilitate needle access | The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Other Pre-specified | Time to First AVF Cannulation | Time to AVF cannulation was defined as the elapsed time to the first use of access site (from the date of the study procedure). | The analysis population analyzed (33) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not requiring cannulation by the 90 day outcome timeframe | Posted | Mean | Standard Deviation | Days | 90 days |
|
|
|
| Other Pre-specified | Catheter Utilization | Catheter utilization was defined as the total number of days a catheter was used before access site maturation per subject. The start date was either 1) the date of the study procedure, for subjects who already had a dialysis catheter in place or 2) the date placed, if during the study. The end date was either 1) the date the catheter was removed or 2) the 90 day visit, if the catheter was still in place. | The analysis population analyzed (32) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not requiring a catheter utilization by the 90 day outcome timeframe | Posted | Mean | Standard Deviation | days | 90 days |
|
|
|
| Other Pre-specified | Target Vessel Location | Anatomic location of matured target vessel | The analysis population analyzed (90) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not achieving an identifiable target vein by the 90 day outcome timeframe | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 18 |
| 103 |
| 28 |
| 103 |
| Endocrine, metabolic nutritional serious adverse events | Endocrine disorders | Systematic Assessment |
|
| Gastrointestinal serious adverse events | Gastrointestinal disorders | Systematic Assessment |
|
| Musculoskeletal serious adverse events | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous system serious adverse events | Nervous system disorders | Systematic Assessment |
|
| Respiratory serious adverse events | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin and subcutaneous serious adverse events | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vascular, blood and lymphatic serious adverse events | Vascular disorders | Systematic Assessment |
|
| Uncoded | Social circumstances | Systematic Assessment |
|
| Immune, infection nonserious events | Immune system disorders | Systematic Assessment |
|
| musculoskeletal nonserious adverse events | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Skin nonserious adverse events | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Surgical procedure nonserious adverse events | Surgical and medical procedures | Systematic Assessment |
|
| Vascular, blood nonserious adverse events | Vascular disorders | Systematic Assessment |
|
| Drug effect nonserious adverse events | Investigations | 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 |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020763 | Pathological Conditions, Anatomical |
| Brachial vein 2 |
|