Chronic Renal Disease, End Stage Renal Disease (ESRD), Hemodialysis, Kidney Failure
Conditions
Brief summary
The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.
Detailed description
The InnAVasc Arteriovenous Graft (IG) is intended for use in ESRD hemodialysis (HD) patients who require HD and whose next most appropriate access is an arteriovenous graft (AVG), also including those who may require an immediate cannulation AVG. Patients with ESRD who require HD and are suitable for an AVG for HD access will be eligible for inclusion in the study. Subjects will be implanted with an InnAVasc Arteriovenous Graft (IG) in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a straight (soft C) configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop). Placing the graft across the elbow will be prohibited. Subjects must be able to be on antiplatelet therapy per the discretion of their physician (e.g., aspirin, clopidogrel, etc.).
Interventions
DEVICEInnAVasc Arteriovenous Graft (IG) surgical implant
The InnAVasc Arteriovenous Graft (IG) is a hemodialysis vascular access graft, intended for implantation in the lower or upper arm using standard vascular techniques, in patients requiring hemodialysis
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, multi-center, single-arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Pre-Operative Inclusion Criteria: Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study: 1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy; 2. Age 18 to 90 years old, inclusive; 3. Suitable anatomy for implantation of upper arm straight or looped graft, or forearm looped graft (graft not to cross the bend of the elbow); 4. Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition); 5. Able and willing to give informed consent; 6. Anticipated life expectancy of at least 1 year. Intra-Operative Inclusion Criteria: Both vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction). Pre-Operative
Exclusion criteria
Patients will be excluded from the study at screening if they exhibit any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secondary patency of study device at 6 months | 6 months | The primary effectiveness endpoint is defined as the proportion of subjects with secondary patency at 6 months. |
| Incidence of adverse events of special interest related to InnAVasc AVG [Time Frame: through 6 months] | 6 months | The primary safety endpoint is the incidence of device-related adverse events of special interest (AESIs) through 6 months, defined as: 1. Infection of the study graft; 2. Pseudoaneurysm formation at any point along the study graft requiring surgical or endovascular intervention (pseudoaneurysms that occur at sites of needle cannulation, but which are small enough to be observed without intervention, do not trigger this element of the AESI endpoint); 3. Bleeding from the study graft requiring surgical or endovascular intervention or ≥2-unit blood transfusion; 4. Hematoma from the study graft requiring surgical or endovascular intervention; 5. Seroma of the study graft requiring surgical or endovascular intervention; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful cannulation on or before Postoperative Day 7 | 7 days | Proportion of subjects achieving successful cannulation on or before Day 7, defined as the first 2-needle dialysis session through the study graft |
| Sustained use | 3, 6, 12, 18 and 24 months | Proportion of subjects achieving sustained use of 3 months, 6, months, 12 months, 18 months and 24 months. Sustained use is a period of time in which the study graft is used for consecutive dialysis sessions without the requirement for alternative hemodialysis vascular access to be used as a route to receive renal replacement therapy. A sustained use period can be achieved at any time throughout the study period of 24 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving successful cannulation among those for whom it was attempted on or before Day 7 | First use of study graft | Exploratory endpoint 5: Proportion of subjects achieving successful cannulation among those for whom it was attempted on or before Day 7, defined as the first 2-needle dialysis session through the study graft |
| Days of central venous catheter insitu | 3, 6, 12, 18 and 24 months | Exploratory endpoint 6: Cumulative catheter days insitu |
| Incidence of individual adverse events | 3, 6, 12, 18 and 24 months | Exploratory endpoint 7: cumulative adverse events, irrespective of device relatedness |
| Primary Patency Rate | 3, 6, 12, 18 and 24 months | Exploratory endpoint 1: Time from creation of access to first intervention to maintain patency or thrombosis |
| Intervention rate to restore or maintain patency | 3, 6, 12, 18 and 24 months | Exploratory outcome 9: Intervention rate to restore or maintain patency (per patient per year) |
| Health Economics data analysis | 3, 6, 12, 18 and 24 months | Exploratory endpoint 10: Health Economic data analysis to be performed based on available study data for the for treatment related costs (e.g. procedural costs, hospital costs, etc.) |
| Change from baseline Patient Reported Outcomes Measures/Patient Reported Experience Measures (PROM/PREM) survey (SF-VAQ); | 3, 6, 12, 18 and 24 months | Exploratory endpoint 8: Change of responses over time from baseline |
| Assisted Primary Patency Rate | 3, 6, 12, 18 and 24 months | Exploratory endpoint 2: Time from creation of access to first thrombosis, irrespective of intervention to maintain patency. |
| Secondary Patency Rate | 3, 6, 12, 18 and 24 months | Exploratory endpoint 3: Time from creation of access to study graft abandonment or achievement of a censored event (death, transfer to peritoneal dialysis, renal transplant, steal, venous hypertension, or end of study period), and includes all surgical and endovascular interventions to reestablish study graft patency. |
| Thrombosis rate per patient | 3, 6, 12, 18 and 24 months | Exploratory endpoint 4: The per patient rate of thrombosis events of the study graft at a particular timepoint. |
Countries
United States
Contacts
Primary ContactBre Lester
Backup ContactManali Joglekar
Outcome results
None listed