Peripheral Artery Disease
Conditions
Brief 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.
Detailed description
This is a prospective, open label, single treatment arm, multicenter phase 2 study to evaluate the safety and efficacy of the HAV in patients with PAD undergoing femoro-popliteal bypass surgery. The primary objective of this study is to evaluate the safety and tolerability of the HAV in these patients and to determine the patency of the Humacyte HAV at 12 months post-implantation. The secondary objectives of this study are to further assess safety in terms of PRA response, and to determine the rates of HAV interventions required to keep the HAV patent. There is no formal hypothesis testing planned; the study involves only a single, open-label treatment group.
Interventions
BIOLOGICALHuman Acellular Vessel (HAV)
Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Sponsors
Atlantic Research Group
Humacyte, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with disabling symptomatic peripheral arterial disease 1. Rutherford stage 4 or 5 who require femoro-popliteal bypass surgery or 2. Rutherford stage 3 with severe claudication (less than 50 yards AND causing severe impairment of ability to work or undertake social activities) 2. Ankle - brachial index ≤ 0.6 in the study leg 3. Patient has failed adequate medical therapy which included 1. Exercise program 2. Smoking cessation therapy 3. Control of diabetes, hypertension and dyslipidemias 4. Antiplatelet therapy 4. Preoperative angiography or CT angiography shows superficial femoral artery occlusion AND required Humacyte Human Acellular Vessel (HAV) length of ≤ 38cm. This imaging may have been conducted up to 6 months prior to study entry provided that the patient's symptoms have remained stable since that time 5. Preoperative imaging shows at least one below knee vessel patent to the ankle with good runoff 6. Proximal HAV anastomosis is expected to be to the common femoral artery below the inguinal ligament or to the superficial femoral artery 7. Distal anastomosis is expected to be to the popliteal artery above the knee 8. Femoral artery occlusion is not considered suitable for endovascular treatment; e.g. long segment chronic total occlusion, previous failed stent or stent graft in the superficial femoral artery, previous failed endovascular treatment where the lesion could not be crossed 9. Autologous vein graft is not feasible in the judgment of the treating surgeon; e.g. because all suitable veins have been used previously for coronary or peripheral bypass, or pre-operative vein mapping shows inadequate length or quality of vein to complete the planned bypass 10. Aged 18 to 85 years old, inclusive 11. Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3 at screening 12. Other hematological and biochemical parameters within a range considered acceptable for the administration of general anesthesia at screening 13. Adequate liver function, defined as serum bilirubin ≤ 1.5 mg/dL; and INR ≤ 1.5 at screening 14. Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures 15. Life expectancy of at least 1 year
Exclusion criteria
1. Leg at high risk of amputation (SVS WIfI stage 4) 2. Recent clinically significant trauma to the leg receiving the HAV 3. Severe active infection (SVS foot infection grade 3) in the leg receiving the HAV 4. Distal anastomosis planned to a below knee artery 5. History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina 6. Stroke within six (6) months prior to study entry (Day 1) 7. Chronic renal disease such that multiple administrations of contrast agents may pose an increased risk of nephrotoxicity (eGFR\<45mL/min) 8. Uncontrolled diabetes (HbA1c \>10% at screening) 9. Treatment with any investigational drug or device within 60 days prior to study entry (Day 1) 10. Cancer that is being actively treated with a cytotoxic agent 11. AIDS / HIV infection 12. Documented hypercoagulable state or history as defined as either: 1. a biochemical diagnosis (e.g. Factor V Leiden, Protein C deficiency, etc.) - OR - 2. a clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g. DVT, PE, etc.) within the previous 5 years 13. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g. von Willebrand disease, etc.). 14. Ongoing treatment with vitamin K antagonists or oral direct thrombin inhibitors or factor Xa inhibitors (e.g. dabigatran, apixaban or rivaroxaban ) 15. Previous arterial bypass surgery (autologous vein or synthetic graft) in the operative leg 16. Stenosis of \>50% of the inflow aortoiliac system ipsilateral to the index leg. Any such stenosis must be corrected with angioplasty with or without stenting prior to, or at the time of, HAV implantation 17. Active autoimmune disease - symptomatic or requiring ongoing drug therapy 18. Active local or systemic infection (WBC \> 15,000/mm3) 19. Known serious allergy to aspirin 20. 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) 21. Previous exposure to HAV 22. Employees of the sponsor or patients who are employees or relatives of the investigator 23. Pregnant women or women planning to become pregnant (Women of child bearing potential, WOCBP, must use adequate contraception \[hormonal or barrier method of birth control; abstinence\] for the duration of study participation; WOCBP defined as not sterile or not \> 1 year postmenopausal.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site | 12 months | — |
| Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | 12 months | — |
| Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) | 12 months | Primary patency = patent (open to blood flow) without any interventions; Primary-assisted patency = patent without an intervention to clear a thrombus; Secondary patency = patent with or without interventions |
| Number of Participants With Adverse Events | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle Brachial Index (ABI) | 12 months | Normal: 1.0 - 1.4 Borderline: 0.9 - 1.0 Mild PAD (peripheral artery disease): 0.8 - 0.9 Moderate PAD: 0.4 - 0.7 Severe PAD: \< 0.4 |
| Mean Vascular Quality of Life Questionnaire (VascuQoL) Score (1-7) for Patients With PAD Symptoms | 12 months | scoring per Vascular Quality of Life Questionnaire (VascuQoL) Likert scale: 7, there is 1 (the worst) to 7 (the best possible) |
| Six Minute Walk Test - Duration | 12 months | — |
| Number of Participants With a Change in Panel Reactive Antibodies (PRA) From Baseline | 12 months | — |
| Changes From Baseline in Hematology Parameters - Hematocrit | 12 months | — |
| Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | 12 months | — |
| Changes From Baseline in Coagulation Parameters - Activated Partial Thromboplastin Time | 12 months | — |
| Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | 12 months | — |
| Changes From Baseline in Clinical Chemistry Parameters - Albumin | 12 months | — |
| Six Minute Walk Test - Distance | 12 months | — |
| Microscopic Evidence of HAV Remodeling (Host Cells Within HAV) | 12 months | — |
| Changes From Baseline in Hematology Parameters - Hemoglobin | 12 months | — |
| Changes From Baseline in Coagulation Parameters - International Normalized Ratio (INR) | 12 months | — |
| Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium | 12 months | — |
| Number of Participants With HAV Interventions | 12 months | e.g., angioplasty, thrombectomy, surgical revision |
Other
| Measure | Time frame |
|---|---|
| Evidence of Aneurysmal Dilatation (Conduit Lumen Diameter >9 mm) or Stenosis of the HAV (>70%) on Routine Clinical US | 60 months |
| Frequency of HAV Remaining as a Functional Conduit in Situ (With or Without Interventions) | 60 months |
| Patient Survival | 60 months |
Countries
United States
Participant flow
Recruitment details
A total of 20 patients were screened, and 15 patients received the HAV at 6 study centers in the United States of America.
Participants by arm
| Arm | Count |
|---|---|
| HAV Treatment Human Acellular Vessel (HAV)
Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Death | 1 |
| Overall Study | Ongoing | 6 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | HAV Treatment |
|---|---|
| Age, Customized >54 and <75 years | 15 Participants |
| Body Mass Index (BMI) | 29.0 kg/m^2 STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 168.6 cm STANDARD_DEVIATION 11.48 |
| Pack years | 24.2 Pack years STANDARD_DEVIATION 12.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
| Smoking History Current | 4 Participants |
| Smoking History Former | 11 Participants |
| Smoking History Never | 0 Participants |
| Weight | 81.5 kg STANDARD_DEVIATION 13.81 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 15 |
| other Total, other adverse events | 15 / 15 |
| serious Total, serious adverse events | 11 / 15 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HAV Treatment | Number of Participants With Adverse Events | Number of Participants with Any AE | 15 Participants |
| HAV Treatment | Number of Participants With Adverse Events | Number of Participants with Mild AEs | 11 Participants |
| HAV Treatment | Number of Participants With Adverse Events | Number of Participants with Moderate AEs | 13 Participants |
| HAV Treatment | Number of Participants With Adverse Events | Number of Participants with Severe AEs | 12 Participants |
| HAV Treatment | Number of Participants With Adverse Events | Number of Participants with Life-threatening AEs | 0 Participants |
| HAV Treatment | Number of Participants With Adverse Events | Number of Participants with Death | 1 Participants |
Primary
Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAV Treatment | Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site | Number of Participants with aneurysm formation | 0 Participants |
| HAV Treatment | Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site | Number of Participants with Anastomotic bleeding or spontaneous rupture | 0 Participants |
| HAV Treatment | Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site | Number of Participants with HAV infection | 0 Participants |
| HAV Treatment | Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site | Number of Participants with HAV removal | 0 Participants |
| HAV Treatment | Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site | Number of Participants with Significant inflammation at the HAV implantation site | 0 Participants |
Primary
Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary)
Primary patency = patent (open to blood flow) without any interventions; Primary-assisted patency = patent without an intervention to clear a thrombus; Secondary patency = patent with or without interventions
Time frame: 12 months
Population: One patient died prior to the Month 12 visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HAV Treatment | Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) | Number of Participants with Primary Patency at Month 12 | Yes | 6 Participants |
| HAV Treatment | Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) | Number of Participants with Primary Patency at Month 12 | No | 8 Participants |
| HAV Treatment | Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) | Number of Participants with Primary Assisted Patency at Month 12 | Yes | 8 Participants |
| HAV Treatment | Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) | Number of Participants with Primary Assisted Patency at Month 12 | No | 6 Participants |
| HAV Treatment | Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) | Number of Participants with Secondary Patency at Month 12 | Yes | 9 Participants |
| HAV Treatment | Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) | Number of Participants with Secondary Patency at Month 12 | No | 5 Participants |
Primary
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria)
Time frame: 12 months
Population: One patient did not complete Month 6 visit due to COVID-19-related hospital restrictions; One patient was not assessed at the scheduled Month 9 visit; One patient died prior to the Month 9 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAV Treatment | Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | Number of Participants with Hemodynamically Significant Stenosis: Month 6 | 2 participants |
| HAV Treatment | Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | Number of Participants with Hemodynamically Significant Stenosis: Month 9 | 1 participants |
| HAV Treatment | Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | Number of Participants with Hemodynamically Significant Stenosis: Month 12 | 0 participants |
| HAV Treatment | Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | Number of Participants with Hemodynamically Significant Stenosis in Proximal Anastomosis | 2 participants |
| HAV Treatment | Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | Number of Participants with Hemodynamically Significant Stenosis in Distal Anastomosis | 1 participants |
| HAV Treatment | Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | Number of Participants with Hemodynamically Significant Stenosis in Immediate Inflow Artery | 0 participants |
| HAV Treatment | Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | Number of Participants with Hemodynamically Significant Stenosis in HAV Bypass | 0 participants |
| HAV Treatment | Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | Number of Participants with Hemodynamically Significant Stenosis in Immediate Outflow Artery | 0 participants |
| HAV Treatment | Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) | Number of Participants with Hemodynamically Significant Stenosis in Presence of Aneurysm | 0 participants |
Secondary
Ankle Brachial Index (ABI)
Normal: 1.0 - 1.4 Borderline: 0.9 - 1.0 Mild PAD (peripheral artery disease): 0.8 - 0.9 Moderate PAD: 0.4 - 0.7 Severe PAD: \< 0.4
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAV Treatment | Ankle Brachial Index (ABI) | 0.902 units on a scale | Standard Deviation 0.15 |
Secondary
Changes From Baseline in Clinical Chemistry Parameters - Albumin
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Albumin | Albumin (g/dL) | 3.93 g/dL | Standard Deviation 0.29 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Albumin | Albumin (g/dL) Change From Baseline | 0.39 g/dL | Standard Deviation 0.8 |
Secondary
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | Calcium (mg/dL) | 9.38 mg/dL | Standard Deviation 0.43 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | Calcium (mg/dL) Change From Baseline | 0.28 mg/dL | Standard Deviation 0.51 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | BUN (mg/dL) | 20.9 mg/dL | Standard Deviation 17.2 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | BUN (mg/dL) Change From Baseline | 8.7 mg/dL | Standard Deviation 16.3 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | Total Bilirubin (mg/dL) | 0.51 mg/dL | Standard Deviation 0.21 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | Total Bilirubin (mg/dL) Change From Baseline | -0.02 mg/dL | Standard Deviation 0.25 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | Creatinine (mg/dL) | 1.118 mg/dL | Standard Deviation 0.471 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | Creatinine (mg/dL) Change From Baseline | 0.188 mg/dL | Standard Deviation 0.429 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | Glucose (non-fasting) (mg/dL) | 110.1 mg/dL | Standard Deviation 44.2 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose | Glucose (non-fasting) (mg/dL) Change From Baseline | 0.9 mg/dL | Standard Deviation 29.6 |
Secondary
Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium | Sodium (mmol/L) | 138.3 mmol/L | Standard Deviation 3.6 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium | Sodium (mmol/L) Change From Baseline | -0.1 mmol/L | Standard Deviation 2 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium | Potassium (mmol/L) | 4.51 mmol/L | Standard Deviation 0.34 |
| HAV Treatment | Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium | Potassium (mmol/L) Change From Baseline | 0.25 mmol/L | Standard Deviation 0.32 |
Secondary
Changes From Baseline in Coagulation Parameters - Activated Partial Thromboplastin Time
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Changes From Baseline in Coagulation Parameters - Activated Partial Thromboplastin Time | Activated Partial Thromboplastin Time (sec) | 27.26 seconds | Standard Deviation 3.54 |
| HAV Treatment | Changes From Baseline in Coagulation Parameters - Activated Partial Thromboplastin Time | Activated Partial Thromboplastin Time (sec) Change From Baseline | 0.18 seconds | Standard Deviation 2.14 |
Secondary
Changes From Baseline in Coagulation Parameters - International Normalized Ratio (INR)
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Changes From Baseline in Coagulation Parameters - International Normalized Ratio (INR) | International Normalized Ratio (INR) | 0.983 ratio | Standard Deviation 0.067 |
| HAV Treatment | Changes From Baseline in Coagulation Parameters - International Normalized Ratio (INR) | INR Change From Baseline | -0.080 ratio | Standard Deviation 0.094 |
Secondary
Changes From Baseline in Hematology Parameters - Hematocrit
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Changes From Baseline in Hematology Parameters - Hematocrit | Hematocrit (%) | 41.69 percentage | Standard Deviation 4.65 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Hematocrit | Hematocrit (%) Change From Baseline | 1.20 percentage | Standard Deviation 3.78 |
Secondary
Changes From Baseline in Hematology Parameters - Hemoglobin
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Changes From Baseline in Hematology Parameters - Hemoglobin | Hemoglobin (g/dL) | 13.40 g/dL | Standard Deviation 1.69 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Hemoglobin | Hemoglobin (g/dL) Change From Baseline | 0.07 g/dL | Standard Deviation 1.24 |
Secondary
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Lymphocytes Count (x 10^3/uL) | 2.459 cells x 10^3/uL | Standard Deviation 0.931 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Lymphocytes Count (x 10^3/uL) Change From Baseline | -0.186 cells x 10^3/uL | Standard Deviation 0.45 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Monocytes Count (x 10^3/uL) | 0.623 cells x 10^3/uL | Standard Deviation 0.133 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Monocytes Count (x 10^3/uL) Change From Baseline | 0.004 cells x 10^3/uL | Standard Deviation 0.207 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Eosinophils Count (x 10^3/uL) | 0.257 cells x 10^3/uL | Standard Deviation 0.21 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Eosinophils Count (x 10^3/uL) Change From Baseline | 0.073 cells x 10^3/uL | Standard Deviation 0.139 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Basophils Count (x 10^3/uL) | 0.046 cells x 10^3/uL | Standard Deviation 0.017 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Basophils Count (x 10^3/uL) Change From Baseline | 0.009 cells x 10^3/uL | Standard Deviation 0.012 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | White Blood Cells (x 10^3/uL) | 8.399 cells x 10^3/uL | Standard Deviation 2.545 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | White Blood Cells (x 10^3/uL) Change From Baseline | -0.212 cells x 10^3/uL | Standard Deviation 2.103 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Neutrophils Count (x 10^3/uL) | 5.079 cells x 10^3/uL | Standard Deviation 1.69 |
| HAV Treatment | Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts | Absolute Neutrophils Count (x 10^3/uL) Change From Baseline | 0.046 cells x 10^3/uL | Standard Deviation 1.725 |
Secondary
Mean Vascular Quality of Life Questionnaire (VascuQoL) Score (1-7) for Patients With PAD Symptoms
scoring per Vascular Quality of Life Questionnaire (VascuQoL) Likert scale: 7, there is 1 (the worst) to 7 (the best possible)
Time frame: 12 months
Population: Mean total VascuQol score at 12 months. One patient died prior to the Month 12 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAV Treatment | Mean Vascular Quality of Life Questionnaire (VascuQoL) Score (1-7) for Patients With PAD Symptoms | 5.9 score on a scale | Standard Deviation 1.03 |
Secondary
Microscopic Evidence of HAV Remodeling (Host Cells Within HAV)
Time frame: 12 months
Population: Removal of the HAV would be applicable if there were an indication (e.g., HAV-related complication) for surgical explantation; in this study there were no HAV-related complications warranting the need for surgical excision/removal.
Secondary
Number of Participants With a Change in Panel Reactive Antibodies (PRA) From Baseline
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HAV Treatment | Number of Participants With a Change in Panel Reactive Antibodies (PRA) From Baseline | 0 Participants |
Secondary
Number of Participants With HAV Interventions
e.g., angioplasty, thrombectomy, surgical revision
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAV Treatment | Number of Participants With HAV Interventions | Number of Participants with HAV intervention due to anastomotic or mid-HAV stenosis | 2 participants |
| HAV Treatment | Number of Participants With HAV Interventions | NUmber of Participant with HAV intervention proximal to the HAV to treat arterial inflow obstruction | 1 participants |
Secondary
Six Minute Walk Test - Distance
Time frame: 12 months
Population: One patient did not complete the test. One patient died prior to the Month 12 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Six Minute Walk Test - Distance | Distance (in) | 362.514 inch | Standard Deviation 143.545 |
| HAV Treatment | Six Minute Walk Test - Distance | Change in Distance From Baseline | 162.049 inch | Standard Deviation 164.127 |
Secondary
Six Minute Walk Test - Duration
Time frame: 12 months
Population: One patient did not complete the test. One patient died prior to the Month 12 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HAV Treatment | Six Minute Walk Test - Duration | Duration (Minutes) | 6.0 minutes | Standard Deviation 0 |
| HAV Treatment | Six Minute Walk Test - Duration | Change in Duration From Baseline | 0.472 minutes | Standard Deviation 1.154 |
Other Pre-specified
Evidence of Aneurysmal Dilatation (Conduit Lumen Diameter >9 mm) or Stenosis of the HAV (>70%) on Routine Clinical US
Time frame: 60 months
Other Pre-specified
Frequency of HAV Remaining as a Functional Conduit in Situ (With or Without Interventions)
Time frame: 60 months
Other Pre-specified
Patient Survival
Time frame: 60 months