What side effects are associated with this type of intervention?

Common side effects of percutaneous treatments for Peripheral Arterial Disease, such as angioplasty and stent placement, include bleeding at the puncture site, infection, allergic reactions to contrast dye, and vessel damage. Less common but more severe complications can include blood clots, restenosis, and kidney damage due to contrast dye. Patients may also experience pain or discomfort at the treatment site.

What prior FDA approvals exist?

The FDA has approved several treatments for Peripheral Arterial Disease (PAD) that involve percutaneous interventions and the use of stent grafts. Notably, the Zilver PTX Drug-Eluting Peripheral Stent and the Lutonix 035 Drug Coated Balloon PTA Catheter are approved for treating femoropopliteal artery disease. These devices are designed to open narrowed arteries and maintain blood flow, similar to the PQ Bypass System's approach of using guidewires and stent grafts for femoropopliteal bypass. Additionally, other treatments like the Supera Peripheral Stent System and the IN.PACT Admiral Drug-Coated Balloon have also received FDA approval for PAD management, focusing on improving arterial patency and reducing restenosis.

What other types of research exist?

Promising alternatives to the PQ Bypass System for PAD patients include: 1) Endovascular revascularization techniques such as drug-coated balloons (DCBs) and drug-eluting stents (DES), which have shown improved patency rates and reduced restenosis. 2) Supervised exercise therapy, which has demonstrated long-term effectiveness in improving walking distance and quality of life. 3) Hybrid revascularization approaches combining endovascular and surgical techniques for complex lesions. These alternatives offer varied benefits and should be discussed with a healthcare provider to determine the best individualized treatment plan.

← Back to Search

Stent Graft

PQ Bypass System for Peripheral Arterial Disease

Q: What is the mechanism of action of this treatment?

The most common treatments for Peripheral Arterial Disease (PAD) include percutaneous interventions, exercise therapy, pharmacologic therapy, and surgical interventions. Percutaneous interventions, such as the PQ Bypass System, involve the use of guidewires and stent grafts to create a bypass around blocked arteries, improving blood flow to the lower extremities. This is crucial for patients with severe PAD as it can prevent limb loss and improve quality of life. Exercise therapy enhances blood circulation and muscle efficiency, while pharmacologic therapies, including antiplatelet agents and statins, reduce cardiovascular risk and prevent disease progression. Surgical interventions, such as bypass grafting, provide an alternative when less invasive methods are insufficient. These treatments collectively aim to alleviate symptoms, improve mobility, and reduce the risk of severe complications like critical limb ischemia and amputation.

N/A

Waitlist Available

Research Sponsored by Endologix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has a patent popliteal artery (<50% stenosis) distal to the landing zone

Symptomatic femoropopliteal chronic total occlusions ≥ 20 cm that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a 70% lesion that includes de novo, restenotic or in-stent restenosis, by investigator visual assessment

Must not have

Previous bypass surgery on the target limb that would inhibit adequate crossing proximally and distally. (e.g. the SFA artery was ligated during the bypass surgery)

Subject has significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as 30% residual stenosis, without complication)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the PQ Bypass System, which helps doctors place stents in leg arteries through a small incision. It aims to help patients with blocked leg arteries by creating a new route for blood flow. Previous evaluations have shown its safety and effectiveness.

Who is the study for?

This trial is for adults aged 18-90 with chronic, symptomatic lower limb ischemia (Rutherford categories 3, 4, or 5) and severe blockages in the leg arteries. Participants must be able to follow a two-year follow-up plan and have no major health issues that would interfere with the study.

What is being tested?

The PQ Bypass System is being tested for its safety and effectiveness in creating a bypass around blocked arteries in the leg using stent grafts without open surgery. This single-arm study involves multiple centers where participants receive this new treatment.

What are the potential side effects?

While specific side effects are not listed here, similar procedures may include risks such as infection at the access site, bleeding, blood vessel damage, or reactions to materials used. The procedure aims to avoid major surgery but carries some typical interventional risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My artery in the knee area is mostly unblocked.

Select...

I have a blocked artery in my leg that is at least 20 cm long or a narrowed artery that is at least 24 cm.

Select...

I have at least one open blood vessel below my knee with good blood flow to my ankle or foot.

Select...

I am between 18 and 90 years old.

Select...

I have chronic pain or sores on my legs due to poor blood flow.

Select...

I had a blocked artery near the treatment area successfully cleared with no complications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had bypass surgery that affects the ability to perform procedures on my limb.

Select...

I have a major blockage in my heart that hasn't been effectively treated.

Select...

I have a stent near the start of my superficial femoral artery.

Select...

My kidney function is very low or I am on dialysis.

Select...

My leg circulation issue is mild or I have severe tissue loss.

Select...

I have a bleeding disorder or my blood doesn't clot properly.

Select...

I have had, or will have, a major part of my limb amputated.

Select...

I have had a deep vein clot in the limb being studied.

Select...

I am allergic to the drugs or devices used in this study and cannot be safely treated for these allergies.

Select...

I have an aneurysm or a recent clot in my limb.

Select...

My severe obesity affects safe medical procedures or my ability to move.

Select...

I do not have a severe infection or symptoms of a systemic inflammatory response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint - Patency at 12 Months

Primary Safety Endpoint at 30 Days

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

The PQ Bypass system is used during a minimally invasive procedure to place stent grafts in the peripheral vasculature to improve blood flow.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PQ Bypass System

2021

N/A

~20

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Peripheral Arterial Disease (PAD) include percutaneous interventions, exercise therapy, pharmacologic therapy, and surgical interventions. Percutaneous interventions, such as the PQ Bypass System, involve the use of guidewires and stent grafts to create a bypass around blocked arteries, improving blood flow to the lower extremities. This is crucial for patients with severe PAD as it can prevent limb loss and improve quality of life. Exercise therapy enhances blood circulation and muscle efficiency, while pharmacologic therapies, including antiplatelet agents and statins, reduce cardiovascular risk and prevent disease progression. Surgical interventions, such as bypass grafting, provide an alternative when less invasive methods are insufficient. These treatments collectively aim to alleviate symptoms, improve mobility, and reduce the risk of severe complications like critical limb ischemia and amputation.

Subintimal angioplasty: to stent or not to stent?