Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma

Phase 3Active Not RecruitingNCT03005418

Humacyte, Inc.72 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Trauma Vascular System Injury

Interventions

Human Acellular Vessel (HAV)BIOLOGICAL

The investigational medicinal product (IMP) - the Human Acellular Vessel (HAV) is a sterile acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin which can be used for arterial bypass or reconstruction in patients with life or limb threatening vascular trauma. The vessel is 6 mm in diameter and approximately 42 cm in length. The product is supplied on a silicone mandrel immersed in sterile phosphate buffered saline in a sealed and labeled plastic container. The Humacyte HAV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. 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. 3. 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 4. Aged 18 to 85 years old, inclusive 5. 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 6. Patient or relative is able, willing and competent to give informed consent 7. Life expectancy of at least 1 year Exclusion Criteria: 1. Mangled Extremity Severity Score (MESS) of ≥ 7 2. Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury) 3. Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) \> 5 or Injury Severity Score (ISS) \>60) 4. HAV may not be used for coronary artery repair 5. Known pregnant women 6. Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries 7. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAV 8. Previous exposure to HAV 9. Known participation in any investigational study within the last 30 days 10. Employees of the sponsor or patients who are employees or relatives of the investigator

Locations (32)

Outcomes

Primary Outcomes

HAV primary patency

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

Time frame: 30 days

Frequency and Severity of Adverse Events

Time frame: 36 months

Secondary Outcomes

Limb viability (avoidance of amputation; limb cohort only)

Time frame: 36 months

HAV primary patency

Time frame: 36 months

HAV primary assisted patency

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

Time frame: 36 months

HAV secondary patency

Secondary patency is defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions

Time frame: 36 months

Rate of HAV interventions

Time frame: 36 months

Patient survival

Data from ClinicalTrials.gov

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Jacob Medical Center at UC San Diego

La Jolla, California, United States

Keck Hospital of University of Southern California (USC)

Los Angeles, California, United States

Cedars-Sinai Medical Cener

Los Angeles, California, United States

UCI Medical Center

Orange, California, United States

University California, Davis

Sacramento, California, United States

University of California San Diego (UCSD) Medical Center

San Diego, California, United States

Ernest E Moore Shock Trauma Center at Denver Health

Denver, Colorado, United States

UF Health Jacksonville

Jacksonville, Florida, United States

Jackson South Medical Center

Miami, Florida, United States

Ryder Trauma Center

Miami, Florida, United States

...and 22 more locations