At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
Human Acellular Vessel (HAV)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Use as a Vascular Prosthesis for Femoro-Popliteal Bypass in Patients With Peripheral Arterial Disease
In Brief
A Phase 2 clinical trial evaluating Human Acellular Vessel (HAV) for Peripheral Artery Disease. Completed, enrolled 15 participants across 5 sites.
Detailed Summary
This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when surgically implanted into a leg to improve blood flow in patients with peripheral arterial disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease
CountriesUnited States
CollaboratorsAtlantic Research Group
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartDec 2016
Primary CompletionDec 2020
Study CompletionDec 2023
TodayJul 2026
First PostedSep 2, 2016
Enrollment StartDec 20, 2016
Primary CompletionDec 1, 2020
Study CompletionDec 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.8 years ago
Interventions
Human Acellular Vessel (HAV)biological
Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques