Kidney Failure, ChronicNCT03645681

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

A study testing InnAVasc arteriovenous graft surgical implant in people with Kidney Failure, Chronic and Renal Dialysis, run by W.L.Gore & Associates at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Kidney Failure, Chronic, Renal Dialysis
What is being tested?: InnAVasc arteriovenous graft surgical implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 7 sitesUnited States
Study dates: 2 Jan 2019to 16 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with ESRD who are not, or who are no longer, candidates for creation of an autologous AV fistula and therefore need placement of an AV graft to start or maintain hemodialysis therapy;
Age 18 to 80 years old, inclusive;
Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);
For patients NOT on Coumadin / warfarin, international normalized ratio (INR) ≤1.5;
Able and willing to give informed consent;
Anticipated life expectancy of at least 1 year.
Additional inclusion criteria on Day 0 (intraoperative):
Both vessels have been exposed and are deemed appropriate for implantation 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).

Who cannot join

History or evidence of severe cardiac disease (New York Heart Association [NYHA] Functional Class III or IV), myocardial infarction within 6 months prior to enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina;
Diabetes with a hemoglobin A1c (HbA1c) > 10%
For upper arm straight configuration, antecubital fossa crease to axillary crease distance < 18 cm.
History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e. arterial inflow insufficient to support hemodialysis access);
Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;
In the opinion of the investigator, baseline hypotension, or history of frequent hypotensive episodes during dialysis that puts the patient at increased risk of graft thrombosis;

Show all 20Show fewer

In the opinion of the investigator, uncontrolled hypertension;
Baseline hemoglobin <8 g/dL;
Baseline platelet count <100,000 or >500,000 cells/mm3;
Documented history of stroke within 6 months prior to enrollment;
Treatment with any investigational drug or device within 30 days prior to enrollment;
Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy);
History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;
Immunodeficiency, including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable;
Documented or suspected hypercoagulable state;
Bleeding diathesis, other than that associated with ESRD;
Documented history of heparin-induced thrombocytopenia (HIT);
Active local or systemic infection as documented from the medical history or bloodwork / blood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;
Scheduled renal transplant within 6 months;
Any other condition which in the judgment of the investigator would preclude adequate evaluation

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226
Inova Health Care Service
Falls Church, Virginia, 22042
Michigan Vascular Center
Flint, Michigan, 48507
Greenwood Leflore Hospital
Greenwood, Mississippi, 38930
Dialysis Access Institute at the Regional Medical Center
Orangeburg, South Carolina, 29118-1498
California Institute of Renal Research
San Diego, California, 92123

Other trials in United States

About this study

Official title: A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease

The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD). The InnAVasc AVG is implanted and used similar to other standard of care dialysis grafts currently on the market. However, the InnAVasc AVG has been uniquely designed to potentially allow for immediate needle access (same day as implant surgery as opposed to 2-4 weeks of waiting), to potentially reduce excessive bleeding from the graft after dialysis, and it may provide protection from improper or missed needle cannulation attempts.

Read the detailed description

This clinical investigation is a prospective, multi-center, single arm, non-randomized study. Participants with ESRD who require hemodialysis and are suitable for an AVG for hemodialysis access will be eligible for inclusion in the study. Suitable participants will be 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). Twenty-six (26) participants will be enrolled to be implanted with the InnAVasc AVG from up to 7 investigational sites in the United States.

The primary effectiveness endpoint of secondary graft patency will be assessed at 6 months but the total study duration is 24 months. The primary safety endpoint will include characterization of dialysis graft adverse events over 6 months. It is hypothesized that the InnAVasc AVG will provide a secondary patency rate similar to the current standard of care dialysis access grafts on the market, but will have the potential to reduce needle cannulation-related adverse events and complications.

Conditions: Kidney Failure, Chronic, Renal Dialysis
Being tested: InnAVasc arteriovenous graft surgical implant
Keywords: Vascular Access, Hemodialysis Access, End Stage Renal Disease, Kidney Failure, Hemodialysis, Arteriovenous Graft, AVG, Cannulation, Quick Sealing dialysis graft
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InnAVasc arteriovenous graft surgical implantDevice
An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants

Study groups in NCT03645681
Study group	Role	What they receive
InnAVasc AVG treatment	Experimental	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). Receives: Device: InnAVasc arteriovenous graft surgical implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Secondary Patency of InnAVasc AVG 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.
Measured: at 6 months
Incidence of Adverse Events of Special Interest (AESIs) 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.
Measured: through 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 201916 Jan 2024

First posted24 Aug 2018
Study start2 Jan 2019
Primary completion28 Sep 2019
Study completion16 Jan 2024

Why it stopped: Concerns around a high rate of thrombosis associated with kinking between the pod and the non-ringed graft.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Patients will be implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques. There are two model versions of the InnAVasc Graft. The looped model and the straight model. 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).
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03645681
Sponsor's protocol ID: CSP-1001
Other IDs: 2R44DK108488-02
Status last verified: May 2024
First submitted: 22 Aug 2018
Last updated: 9 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
ClinicalTrials.gov ID: NCT03645681
Acronym / sponsor ID: CSP-1001
Conditions: Kidney Failure, Chronic, Renal Dialysis
Keywords: Vascular Access, Hemodialysis Access, End Stage Renal Disease, Kidney Failure, Hemodialysis, Arteriovenous Graft, AVG, Cannulation
Study type: Interventional
Recruitment status: TerminatedReason stopped: Concerns around a high rate of thrombosis associated with kinking between the pod and the non-ringed graft.
Enrolment: 26 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 2 Jan 2019 (actual)
Primary completion: 28 Sep 2019 (actual)
Study completion: 16 Jan 2024 (actual)
First posted: 24 Aug 2018 (actual)
Results: Posted 15 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Patients will be implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques. There are two model versions of the InnAVasc Graft. The looped model and the straight model. 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).

Arm	Type	Receives
InnAVasc AVG treatment	Experimental	Device: InnAVasc arteriovenous graft surgical implantPatients 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).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients with ESRD who are not, or who are no longer, candidates for creation of an autologous AV fistula and therefore need placement of an AV graft to start or maintain hemodialysis therapy;
Age 18 to 80 years old, inclusive;
Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);
For patients NOT on Coumadin / warfarin, international normalized ratio (INR) ≤1.5;
Able and willing to give informed consent;

Key exclusion criteria (20 listed)

History or evidence of severe cardiac disease (New York Heart Association [NYHA] Functional Class III or IV), myocardial infarction within 6 months prior to enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina;
Diabetes with a hemoglobin A1c (HbA1c) > 10%
For upper arm straight configuration, antecubital fossa crease to axillary crease distance < 18 cm.
History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e. arterial inflow insufficient to support hemodialysis access);
Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InnAVasc arteriovenous graft surgical implantAn InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants	Device	InnAVasc AVG treatment

Primary outcome

Secondary Patency of InnAVasc AVG at 6 Months
Time frame: 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.
Incidence of Adverse Events of Special Interest (AESIs) Through 6 Months
Time frame: 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.

Results and safety

Results posted to the registry on 15 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
InnAVasc AVG Treatment	26	1

Primary outcome: Secondary Patency of InnAVasc AVG at 6 Months

Time frame: at 6 months. Count of participants. Unit: Participants

Measure	InnAVasc AVG Treatment n = 26
Value	7

Primary outcome: Incidence of Adverse Events of Special Interest (AESIs) Through 6 Months

Time frame: through 6 months. Number. Unit: Adverse Events

Measure	InnAVasc AVG Treatment n = 26
Value	56

Adverse events

Time frame: Adverse events are evaluated through study completion of 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
InnAVasc AVG Treatment	12 of 26 (46.2%)	24 of 26 (92.3%)	3 of 26

Limitations and caveats (from the sponsor): Enrollment was terminated before enrollment was completed, and subject attrition rates prevented full analysis of endpoints.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing InnAVasc arteriovenous graft surgical implant in people with Kidney Failure, Chronic and Renal Dialysis, run by W.L.Gore & Associates at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Secondary Patency of InnAVasc AVG at 6 Months (time frame: at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03645681.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.