PQ Bypass System for Peripheral Arterial Disease

Recruiting at 2 trial locations

Overseen By Colleen Holthe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endologix

Disqualifiers: Renal disease, Pregnancy, Recent stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 1 day

11 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the PQ Bypass System treatment for Peripheral Arterial Disease?

Research on peripheral bypass surgery, a similar treatment, shows that it can improve quality of life and help save limbs in patients with peripheral arterial disease. Additionally, studies on revascularization procedures, which aim to restore blood flow, indicate significant improvements in patient-reported outcomes and quality of life. ^{1 2 3 4 5}

Is the PQ Bypass System safe for humans?

The PQ Bypass DETOUR System has been studied for safety over one and two years in patients with femoropopliteal occlusive disease, showing it is generally safe for use in humans. ^{6 7 8 9 10}

How is the PQ Bypass System treatment different from other treatments for peripheral arterial disease?

The PQ Bypass System is unique because it involves a minimally invasive procedure called percutaneous femoropopliteal bypass, which redirects blood flow through a vein to bypass blocked arteries, unlike traditional surgical bypass that requires open surgery. This approach can be beneficial for patients who cannot undergo conventional surgery due to extensive artery blockages. ^{1 3 11 12 13}

Eligibility Criteria

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.

Inclusion Criteria

Your venous clinical severity score is less than 3.

My artery in the knee area is mostly unblocked.

Willing and able to provide informed consent

Exclusion Criteria

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

Subject is pregnant or breast-feeding

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits over 12 months

Treatment Details

Interventions

• PQ Bypass System

Trial Overview 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.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Endologix

Lead Sponsor

Trials

23

Recruited

3,900+

PQ Bypass, Inc.

Lead Sponsor

Trials

6

Recruited

560+

Findings from Research

In a study of 3194 patients with peripheral arterial disease (PAD) who underwent revascularization, the minimum important difference for health-related quality of life (HRQoL) as measured by the VascuQoL-6 (VQ-6) was found to be between 1.7 to 2.2 scale steps for patients with intermittent claudication and 1.9 scale steps for those with critical limb ischemia after one year.

The study established that a substantial clinical benefit, indicated by VQ-6 scores, occurs at thresholds of 3.5 scale steps for intermittent claudication patients and 4.5 scale steps for critical limb ischemia patients, providing valuable benchmarks for evaluating treatment outcomes in clinical practice and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Minimum Important Difference and Substantial Clinical Benefit with the Vascular Quality of Life Questionnaire-6 when Evaluating Revascularisation Procedures in Peripheral Arterial Disease. Nordanstig, J., Pettersson, M., Morgan, M., et al.[2022]

Paclitaxel drug-coated balloons and drug-eluting stents, introduced for treating intermittent claudication, showed better limb revascularization compared to non-coated devices, but recent studies raised concerns about a potential increase in late all-cause mortality associated with these treatments.

In response to these safety concerns, a Vascular Leaders Forum was convened with 100 experts from various fields to investigate the findings and discuss the implications for patient care, aiming to balance the risks and benefits of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease? Beckman, JA., White, CJ.[2020]

The Peripheral Artery Questionnaire (PAQ) is a reliable and valid tool for measuring health status in patients with peripheral arterial disease, showing strong internal consistency with a Cronbach alpha of 0.80 to 0.94 across its 7 domains.

The PAQ demonstrated significant responsiveness to clinical improvement after revascularization, with score changes ranging from 13.7 to 41.9 points (P < 0.001), making it a sensitive measure for assessing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease. Spertus, J., Jones, P., Poler, S., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Midterm follow-up of quality of life following peripheral bypass surgery. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Drug-eluting stents for infrapopliteal arterial disease in the setting of critical limb ischemia. [2011]

3. Nepal pubmed.ncbi.nlm.nih.gov

Initial Experience of Complex Peripheral Bypass Surgery at Dhulikhel Hospital, Kathmandu University Hospital. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Correlation between Patient-Reported Symptoms and Ankle-Brachial Index after Revascularization for Peripheral Arterial Disease. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Assessment of Minimum Important Difference and Substantial Clinical Benefit with the Vascular Quality of Life Questionnaire-6 when Evaluating Revascularisation Procedures in Peripheral Arterial Disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Peripheral vascular disease and outcomes following coronary artery bypass graft surgery. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic risk factor management in peripheral arterial disease: a vade mecum for vascular surgeons. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease? [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Technical Approach to Percutaneous Femoropopliteal Bypass and Deep Vein Arterialization. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease. [2022]

13. India pubmed.ncbi.nlm.nih.gov

Peripheral artery questionnaire improves ankle brachial index screening in symptomatic patients with peripheral artery disease. [2018]