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

Conditions

• Chronic Renal Disease
• End Stage Renal Disease (ESRD)
• Hemodialysis
• Kidney Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• InnAVasc Arteriovenous Graft (IG) surgical implant — DEVICE
  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

Study Details

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.

Key Dates

Start date

Dec 3, 2020

Status verified

Dec 2025

Primary completion

Dec 1, 2027

Completion

Jul 1, 2029

Study Design

Enrollment

133 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Experimental: InnAVasc AVG treatment
  Patients will be surgically 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).

Primary Outcome Measure

Secondary patency of study device at 6 months [ Time Frame: 6 months ]

Central Contacts

• Bre Lester
  4806986670
  [email protected]
• Manali Joglekar
  9288644063
  [email protected]

Locations (21)

Find similar trials in Phoenix, AZ

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