E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma |
|
E.1.1.1 | Medical condition in easily understood language |
Surgical treatment of vascular injuries which maybe life or limb threatening |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047080 |
E.1.2 | Term | Vascular injury |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022117 |
E.1.2 | Term | Injury, poisoning and procedural complications |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Safety To evaluate the safety and tolerability of the Humacyte HAV in vascular trauma patients undergoing surgery for vascular replacement or reconstruction Efficacy To determine the rate of primary patency at 30 days |
|
E.2.2 | Secondary objectives of the trial |
Safety • To determine mechanical stability of the HAV based on freedom from aneurysmal degeneration, anastomotic bleeding or spontaneous rupture, infection, or significant stenosis • To determine HAV durability in terms of freedom from HAV removal or replacement Efficacy • To determine the patency of the HAV (primary, primary assisted and secondary) • To determine the rates of interventions needed to maintain / restore patency in the HAV • To determine the rate of limb salvage • To determine patient survival • To evaluate remodeling of HAV |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 study procedures. If the patient is unconscious then information from a reliable witness indicates that the patient would normally be able to understand and comply with study procedures 6. Patient or legal representative is able, willing and competent to give informed consent 7. Life expectancy of at least 1 year |
|
E.4 | Principal 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 Humacyte Human Acellular Vessel (HAV) 8. Previous exposure to HAV 9. Known participation in any investigational study within the last 30 days 10. Employees of the sponsor |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety: • Frequency and severity of adverse events Efficacy: • HAV primary patency at 30 days |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days post implantation |
|
E.5.2 | Secondary end point(s) |
Safety: • Frequency of adverse events of special interest: o Anastomotic bleeding or spontaneous rupture o HAV infection o Thrombosis o Pseudoaneurysm formation o Aneurysm formation o Hemodynamically significant stenosis (>70% by duplex ultrasound criteria) • HAV partial or complete removal Efficacy: • HAV primary patency • HAV primary assisted patency • HAV secondary patency • Rate of HAV interventions • Limb salvage (limb cohort only) • Patient survival • HAV remodeling as shown by histopathology of any clinical explants |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
5, 30 days, 3, 6, 9, 12 months, then every 3 months until 36 month post implantation |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial occurs when the last subject remaining on study has reached Month 36 follow up. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |