NCT03005418Phase 2, phase 3Completed

Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-19Actual

Enrollment · participants72Actual

Source updated2026-07-29Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-29 · 4 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: ~~ATEV~~ Primary Patency - ~~Extremity~~ Group ~~(Non-iatrogenic)~~ Measure: Rate of ~~ATEV~~ ~~Infection~~ - Extremity ~~Group~~ ~~(Non-iatrogenic) Measure:~~ ~~Number of Participants With Adverse Events for Each Severity Grade - Extremity Group (Non-iatrogenic)~~

+ After

Measure: Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group Measure: Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup

Actual enrollment increased by 21 participants

− Before

~~51 participants (actual)~~

+ After

72 participants (actual)

Primary completion date changed

− Before

~~30 Jun 2023~~

+ After

19 Sep 2023

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Completed

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Study details

Conditions studied

Trauma; Vascular System Injury

Treatments or interventions studied

Acellular Tissue Engineered Vessel (ATEV)BiologicalAlso known as Human Acellular Vessel (HAV)

Primary outcomes · main study measures

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measure: Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group; description: Rate of primary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.; timeFrame: 30 days from time of implantation; measure: Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup; description: Rate of primary patency at 30 days post-implantation, evaluated strictly within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the 30-day evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.; timeFrame: 30 days from time implantation

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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