Trial Outcomes & Findings for Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure (NCT NCT03645681)

Last Updated: 2025-05-09

Results Overview

Secondary patency is defined as the number of patients free from abandonment, including surgical or endovascular interventions designed to reestablish AVG patency at the 6 month timepoint.

Recruitment status

TERMINATED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

at 6 months

Results posted on

2025-05-09

Participant Flow

Intraoperative enrollment 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 and is safely clampable (i.e. artery has lack of significant calcification); and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).

Participant milestones

Participant milestones
Measure	InnAVasc AVG Treatment Treatment with the InnAVasc arteriovenous graft (IG).
Overall Study STARTED	26
Overall Study Primary Endpoint Analyzed	12
Overall Study Completed 24 Month	3
Overall Study Not Completed	23
Overall Study Entered Long Term Follow Up	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	InnAVasc AVG Treatment n=26 Participants Patients will be surgically implanted with an InnAVasc AVG 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). InnAVasc arteriovenous graft surgical implant: An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants
Age, Continuous	59.9 Years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index	31.4 kg/m^2 STANDARD_DEVIATION 9.8 • n=5 Participants

PRIMARY outcome

Timeframe: at 6 months

Secondary patency is defined as the number of patients free from abandonment, including surgical or endovascular interventions designed to reestablish AVG patency at the 6 month timepoint.

Outcome measures

Outcome measures
Measure	InnAVasc AVG Treatment n=26 Participants Patients will be surgically implanted with an InnAVasc AVG 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). InnAVasc arteriovenous graft surgical implant: An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants
Secondary Patency of InnAVasc AVG at 6 Months	7 Participants

PRIMARY outcome

Timeframe: through 6 months

Adverse Events of special interest included: Infection of the study device, pseudoaneurysm formation at any point along the access circuit requiring surgical/endovascular intervention, including thrombin injection and compression, bleeding from the study graft requiring surgical or endovascular intervention or ≥2 units blood transfusion, hematoma from the study graft requiring surgical or endovascular intervention, seroma from the study graft requiring surgical or endovascular intervention, thrombosis of the study graft.

Outcome measures

Outcome measures
Measure	InnAVasc AVG Treatment n=26 Participants Patients will be surgically implanted with an InnAVasc AVG 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). InnAVasc arteriovenous graft surgical implant: An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants
Incidence of Adverse Events of Special Interest (AESIs) Through 6 Months	56 Adverse Events

Adverse Events

InnAVasc AVG Treatment

Serious events: 12 serious events

Other events: 24 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	InnAVasc AVG Treatment n=26 participants at risk Patients will be surgically implanted with an InnAVasc AVG 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). InnAVasc arteriovenous graft surgical implant: An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants
Vascular disorders Hematoma	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Nervous system disorders Cerebral Infraction with Left Hemiparesis	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Vascular disorders Post Thrombectomy Hematoma	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Cardiac disorders Endocarditis	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Infections and infestations Septic Shock	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Infections and infestations Infection of AV Graft	11.5% 3/26 • Number of events 4 • Adverse events are evaluated through study completion of 24 months
Vascular disorders Thrombosis of AV Graft	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Infections and infestations Bacteremia	11.5% 3/26 • Number of events 3 • Adverse events are evaluated through study completion of 24 months
Gastrointestinal disorders Viral Gastroenteritis	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Cardiac disorders Hypotensive Cardiac Event	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Cardiac disorders Cardiac Arrest	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Respiratory, thoracic and mediastinal disorders Acute Hypoxemic Respiratory Failure	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months

Other adverse events

Other adverse events
Measure	InnAVasc AVG Treatment n=26 participants at risk Patients will be surgically implanted with an InnAVasc AVG 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). InnAVasc arteriovenous graft surgical implant: An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants
Vascular disorders Cannulation Complications	11.5% 3/26 • Number of events 4 • Adverse events are evaluated through study completion of 24 months
Blood and lymphatic system disorders Hematoma	7.7% 2/26 • Number of events 2 • Adverse events are evaluated through study completion of 24 months
Vascular disorders Arteriovenous Graft Site Hematoma	7.7% 2/26 • Number of events 4 • Adverse events are evaluated through study completion of 24 months
Vascular disorders Arteriovenous graft site infection	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Vascular disorders Arteriovenous graft site stenosis	42.3% 11/26 • Number of events 33 • Adverse events are evaluated through study completion of 24 months
Vascular disorders Arteriovenous graft thrombosis	76.9% 20/26 • Number of events 47 • Adverse events are evaluated through study completion of 24 months
Infections and infestations Bacteraemia	7.7% 2/26 • Number of events 2 • Adverse events are evaluated through study completion of 24 months
Injury, poisoning and procedural complications Dehiscence	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Skin and subcutaneous tissue disorders Eschar	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Blood and lymphatic system disorders Hyperkalaemia	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Nervous system disorders Hypoaesthesia	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Injury, poisoning and procedural complications Incision Site Pain	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Injury, poisoning and procedural complications Medical device site extravasation	7.7% 2/26 • Number of events 2 • Adverse events are evaluated through study completion of 24 months
Injury, poisoning and procedural complications Medical device site oedema	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Injury, poisoning and procedural complications Medical device site pain	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Injury, poisoning and procedural complications Post procedural haematoma	15.4% 4/26 • Number of events 4 • Adverse events are evaluated through study completion of 24 months
Injury, poisoning and procedural complications Post procedural haemorrhage	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Blood and lymphatic system disorders Protein C deficiency	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Blood and lymphatic system disorders Seroma	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Vascular disorders Steal Syndrome	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Nervous system disorders Syncope	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Cardiac disorders Tachycardia	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Infections and infestations Urinary Tract Infection	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Vascular disorders Vascular Stenosis	15.4% 4/26 • Number of events 15 • Adverse events are evaluated through study completion of 24 months
Cardiac disorders Hypotensive Cardiac Event	3.8% 1/26 • Number of events 1 • Adverse events are evaluated through study completion of 24 months
Vascular disorders Pseudoaneurysm	7.7% 2/26 • Number of events 2 • Adverse events are evaluated through study completion of 24 months

Additional Information

Bre Lester

W. L. Gore & Associates

Phone: 480-698-6670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place