Human Acellular Vessel (HAV) for Peripheral Arterial Disease

1
Effectiveness
2
Safety
Overlook Medical Center, Summit, NJ
Peripheral Arterial Disease+1 More
Human Acellular Vessel (HAV) - Biological
Eligibility
18+
All Sexes
Eligible conditions
Peripheral Arterial Disease

Study Summary

This study is evaluating whether a new device can improve blood flow in patients with peripheral arterial disease.

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Eligible Conditions

  • Peripheral Arterial Disease
  • Peripheral Arterial Disease (PAD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Human Acellular Vessel (HAV) will improve 4 primary outcomes, 9 secondary outcomes, and 3 other outcomes in patients with Peripheral Arterial Disease. Measurement will happen over the course of 12 months.

12 months
Ankle brachial index (ABI)
Change in PRA from baseline
Changes from baseline in clinical chemistry parameters
Changes from baseline in coagulation parameters
Changes from baseline in hematology parameters
Frequency and severity of adverse events
HAV Patency Rates (Primary, Primary-assisted, Secondary) - see Description
Hemodynamically significant stenosis (>70% by duplex ultrasound criteria)
Incidence of aneurysm formation, anastomotic bleeding or rupture, HAV infection, HAV removal and irritation/inflammation at the HAV implantation site
Microscopic evidence of HAV remodeling (host cells within HAV)
Patient reported PAD symptoms (VascuQol)
Rate of HAV interventions
Six minute walk test
60 months
Evidence of aneurysmal dilatation (conduit lumen diameter >9 mm) or stenosis of the HAV (>70%) on routine clinical US
Frequency of HAV remaining as a functional conduit in situ (with or without interventions)
Patient survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
HAV Treatment

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Human Acellular Vessel (HAV) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

HAV Treatment
Biological
Human Acellular Vessel (HAV)
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 60 months for reporting.

Closest Location

Overlook Medical Center - Summit, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with disabling symptomatic peripheral arterial disease
Rutherford stage 4 or 5 who require femoro-popliteal bypass surgery or Rutherford stage 3 with severe claudication (less than 50 yards AND causing severe impairment of ability to work or undertake social activities)
Ankle - brachial index ≤ 0.6 in the study leg
Patient has failed adequate medical therapy which included
Exercise program
Smoking cessation therapy
Control of diabetes, hypertension and dyslipidemias
Antiplatelet therapy
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
Preoperative imaging shows at least one below knee vessel patent to the ankle with good runoff

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is peripheral arterial disease?

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Findings from a recent study showed that the level of PAD can be accurately calculated using the ABI. Therefore, the level of PAD can be used as a convenient diagnostic tool to identify the abnormal arteries and to differentiate between the normal and pathological arteries. If the ABI is > 0.9, the existence of atherosclerosis can be assumed. If the ABI is <0.9, ABI measurements should be taken when the PAD is suspected.

Unverified Answer

What are the signs of peripheral arterial disease?

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Signs and symptoms of PAD were described in 1 in 18 patients (5.2%). Some common symptoms were intermittent claudication, rest pain, and skin changes. Other less common signs and symptoms were nocturia, reduced sensation, numbness or tingling, and leg paresthesia. None of the 4 (17.6%) patients had evidence of critical limb ischemia at the time of presentation. These symptoms and signs are not sensitive or specific for the diagnosis of PAD.

Unverified Answer

What are common treatments for peripheral arterial disease?

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Findings from a recent study demonstrate that PAD is often treated through lifestyle modification, exercise, or medications. Furthermore, patients may receive complementary and alternative medicine treatment or engage with other supportive interventions.

Unverified Answer

What causes peripheral arterial disease?

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Risk factors for PAD include age, smoking and low levels of HDL. These risk factors may increase the risk for thromboembolic complications. Although PAD is not a primary cause of death, secondary complications can include cardiovascular disease, amputation, or death from complications of lower limb ischemia. Preventive measures should focus on decreasing smoking and improving HDL and statin therapy in people with PAD.

Unverified Answer

Can peripheral arterial disease be cured?

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The risk of death among patients with peripheral arterial disease is only approximately halved by surgical revascularization. These data suggest that revascularization of the peripheral arteries should be performed as aggressively as coronary and cerebrovascular disease revascularization. Nevertheless, in view of higher surgical risks of surgery and the poorer prognosis of peripheral artery disease, surgical revascularization does not seem to be an appropriate investment in health care costs.

Unverified Answer

How many people get peripheral arterial disease a year in the United States?

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Fewer Americans than many other Western countries are getting PAD--approximately 10%. However, in the U.S. PAD is becoming a major cause of disability. Better awareness of PAD and the identification of at-risk populations are urgently needed.

Unverified Answer

What is the average age someone gets peripheral arterial disease?

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The National Health Interview Survey estimates that the rate of PAD was 6.6% in the United States for persons 45 years of age and older. This is higher than other estimates that ranged from 1.4% for persons 70 years of age and older to 5.3% for persons 75 years of age. These estimates indicate that a large number of individuals will have PAD, and an increasing proportion of individuals with PAD will reach those age groups at an ages when diagnosis will be more serious.

Unverified Answer

How does human acellular vessel (hav) work?

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The human acellular vessel shows similar histologic and cellular characteristics to cultured arteries. The hav, a human vessel-like scaffold, is an ideal source of human cells, and might serve as an alternative to autologous artery.

Unverified Answer

Who should consider clinical trials for peripheral arterial disease?

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We found limited evidence to support the use of randomized controlled trials in patients with PAD, particularly among high-risk individuals, such as those with a history of heart failure and those with atherosclerotic cardiovascular disease.

Unverified Answer

Have there been any new discoveries for treating peripheral arterial disease?

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The use of stents may help preserve the vascular function and to reduce the number of hospitalizations. However, there is still room for further research into the exact role of stents in improving long-term results.

Unverified Answer

What does human acellular vessel (hav) usually treat?

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Overall, there was no significant difference in clinical or angiographic outcomes for hAV versus SVS, and therefore there seems no compelling rationale for using hAV in addition to SVS.

Unverified Answer

Has human acellular vessel (hav) proven to be more effective than a placebo?

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The study of the effects of hAV on symptomatic PAD patients with refractory angina is noteworthy because it has demonstrated that there is no clinical benefit of hAV therapy. Recent findings of this large multicenter randomized controlled trial indicate that an agent derived from collagen cannot be recommended for use with patients with severe angina or severe claudication.

Unverified Answer
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