Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma
- Conditions
- TraumaVascular System Injury
- Interventions
- Biological: Human Acellular Vessel (HAV)
- Registration Number
- NCT03005418
- Lead Sponsor
- Humacyte, Inc.
- Brief Summary
This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.
- Detailed Description
This is a prospective, multicenter, multi cohort, non-randomized phase 2 study in up to 40 adult patients with life or limb threatening vascular trauma which requires surgical repair. There will be a limb cohort and a torso cohort. The limb cohort will include patients who require repair of a vessel contained to the upper or lower extremity. The torso cohort includes patients who require repair of vessels within the thorax (excluding the heart), abdomen, and retroperitoneum. Subjects will be implanted with a Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.
The active study duration for each study participant will be 36 months from HAV implantation or until HAV failure/ removal/ death if earlier. Follow up after month 12 will involve the capture of information on assessments performed at "standard of care" routine clinic visits or by telephone follow up with the patient or his/her physician with physical exam and ultrasound at month 24 and month 36
The total expected duration of the clinical study is 61 months (24 months of enrollment and 36 months of follow up).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction
- Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm Human Acellular Vessel (HAV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.
- Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization
- Aged 18 to 85 years old, inclusive
- Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures
- Patient or relative is able, willing and competent to give informed consent
- Life expectancy of at least 1 year
- Mangled Extremity Severity Score (MESS) of ≥ 7
- Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)
- Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) > 5 or Injury Severity Score (ISS) >60)
- HAV may not be used for coronary artery repair
- Known pregnant women
- Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAV
- Previous exposure to HAV
- Known participation in any investigational study within the last 30 days
- Employees of the sponsor or patients who are employees or relatives of the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Human Acellular Vessel (HAV) Human Acellular Vessel (HAV) Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques.
- Primary Outcome Measures
Name Time Method HAV primary patency 30 days Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions
Frequency and Severity of Adverse Events 36 months
- Secondary Outcome Measures
Name Time Method Frequency of HAV removal 36 months Patient survival 36 months Frequency of HAV infection 36 months Frequency of HAV pseudoaneursym formation 36 months Frequency of HAV aneursym formation 36 months Rate of HAV interventions 36 months HAV secondary patency 36 months Secondary patency is defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions
Frequency of anastomotic bleeding or spontaneous rupture 36 months HAV remodeling as shown by histopathology of any clinical explants 36 months Limb viability (avoidance of amputation; limb cohort only) 36 months HAV primary patency 36 months Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions
HAV primary assisted patency 36 months Primary assisted patency is defined as 'the interval from the time of access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of patent access' i.e., patent without an intervention to clear a thrombus
Frequency of HAV thrombosis 36 months Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria) 36 months
Trial Locations
- Locations (32)
Keck Hospital of University of Southern California (USC)
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Cener
🇺🇸Los Angeles, California, United States
Ryder Trauma Center
🇺🇸Miami, Florida, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
R Adams Cowley Baltimore Shock Trauma
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of California San Diego (UCSD) Medical Center
🇺🇸San Diego, California, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Jacob Medical Center at UC San Diego
🇺🇸La Jolla, California, United States
UCI Medical Center
🇺🇸Orange, California, United States
University California, Davis
🇺🇸Sacramento, California, United States
UF Health Jacksonville
🇺🇸Jacksonville, Florida, United States
Ernest E Moore Shock Trauma Center at Denver Health
🇺🇸Denver, Colorado, United States
Jackson South Medical Center
🇺🇸Miami, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Saint Louis University (SLU)
🇺🇸Saint Louis, Missouri, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Atrium Health Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
The University of Texas - Dell Medical School
🇺🇸Austin, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
The Chaim Sheba Medical Center - Vascular Surgery Department
🇮🇱Ramat Gan, Israel
Soroka Medical Center - Vascular Surgery Department
🇮🇱Be'er Sheva, Israel
Rambam Health Care Campus - Vascular Surgery Department
🇮🇱Haifa, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel