Evaluation of STARgraft AV for Hemodialysis Access
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|ClinicalTrials.gov Identifier: NCT03916731|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft. The STARgraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis.
Performance of the STARgraft AV will be compared against control implants of commercially available standard ePTFE grafts approved for the same use.
The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to:
- Demonstrate improved primary patency of the investigational STARgraft AV compared to the ePTFE controls over a period of 6 months, with extended results to 1 year.
- Verify safety of the STARgraft AV multilayer construction in extended vascular access use.
It is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Device: Implant of STARgraft AV shunt in the upper arm and subsequent use for hemodialysis access Device: Implant of standard ePTFE AV graft in the upper arm and subsequent use for hemodialysis access||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Equal numbers of Participants are randomly assigned investigational or control grafts for implant. Study follow up examinations and routine dialysis procedures over the study period are identical for both groups.|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||Randomized Assignment of Investigational and Control devices by Sponsor. Participants and Dialysis Clinics providing routine maintenance hemodialysis care are masked.|
|Official Title:||First in Human Evaluation of STARgraft AV for Hemodialysis Access in Comparison to ePTFE Vascular Grafts|
|Actual Study Start Date :||April 2, 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||September 2020|
Experimental: STARgraft AV
Participants will be implanted with 6mm diameter STARgraft AV grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.
Device: Implant of STARgraft AV shunt in the upper arm and subsequent use for hemodialysis access
After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions. Periodic evaluations of blood flow by ultrasound imaging will be made over the study period. Established standards of care will be followed as needed to maintain dialysis function
Active Comparator: Control (ePTFE)
Participants will be implanted in the same upper arm location with standard 6mm diameter ePTFE dialysis access grafts. All other aspects of this study arm are identical to the Experimental one.
Device: Implant of standard ePTFE AV graft in the upper arm and subsequent use for hemodialysis access
Same as for STARgraft AV but with standard grafts to provide controls
- Primary Unassisted Patency [ Time Frame: 6 months post implantation. ]Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
- Primary Unassisted Patency [ Time Frame: 1, 2, 4, 9 and 12 months post implantation ]Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
- Assisted Primary Patency [ Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation ]Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.
- Secondary Patency (Cumulative Patency) [ Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation ]Percentage of subjects without loss of access at the original implant site.
- Graft Related Infections [ Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation ]Frequency of infections related to graft placement and use for dialysis access.
- Safety Outcomes [ Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation ]Frequency and Severity of Adverse Events resulting from graft implantation and use for hemodialysis access.
- Blood flow rates in grafts. [ Time Frame: 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation. ]Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation
- Peak Systolic Velocity (PSV) Ratio [ Time Frame: 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation ]Ultrasound measurement of PSV (The ratio of flow velocity at the venous anastomosis to that at a point 2cm upstream in the graft)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916731
|Contact: Andrew J Marshall, Ph.D||1 206 432 9060 ext firstname.lastname@example.org|
|Contact: Adrian Ebner, MD + 595 21 202 767 email@example.com|
|Principal Investigator:||Adrian Ebner, MD||Italian Hospital Asuncion Paraguay|