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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Dec 1, 2027 → Mar 1, 2030
See other at-risk trials from W.L.Gore & Associates

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 1, 2027 to Mar 1, 2030 Show 6 more changesShow less
    • Lead sponsor: W.L.Gore & Associates to W.L.Gore & Associates
    • Study completion pushed from Jul 1, 2029 to Sep 1, 2031
    • Study sites: 21 to 22
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Publications: details revised at 2 of 2 entries
  2. Enrollment target: 105 to 133
    • Study sites: 11 to 21
    • Study title shortened, about 1 word
    v10
  3. Study sites: 2 to 11v9
  4. Enrollment target: 60 to 105v8 Show 8 more changesShow less
    • Primary completion date: May 1, 2027 to Dec 1, 2027
    • Study sites: 4 to 2
    • Study completion date: Aug 1, 2029 to Jul 1, 2029
    • Interventions: InnAVasc arteriovenous graft surgical implant (Device) to InnAVasc Arteriovenous Graft (IG) surgical implant (Device)
    • Eligibility criteria shortened, about 134 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 7 words
    • Study title expanded, about 7 words
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: May 1, 2024 to May 1, 2027
    • Study completion date: Aug 1, 2028 to Aug 1, 2029
    v6
  2. Primary completion date: May 1, 2023 to May 1, 2024
    • Study completion date: Aug 1, 2023 to Aug 1, 2028
    v5
  3. Primary completion date: Oct 22, 2022 to May 1, 2023v4
  4. Re-verified, no change to tracked fieldsv3
  5. Lead sponsor: [Redacted] to W.L.Gore & Associatesv2 Show 5 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Oct 22, 2022
    • Study completion date: Aug 1, 2023
    • Start date: Dec 3, 2020
    • Study title expanded, about 3 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04671771
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease, Hemodialysis
Related terms Kidney Failure, Chronic, Renal Insufficiency, Renal Insufficiency, Chronic
Enrollment 133 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov