PQ Bypass System for Peripheral Arterial Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment method called the PQ Bypass System for individuals with Peripheral Arterial Disease (PAD), a condition where narrowed arteries reduce blood flow to the limbs. The treatment involves a minimally invasive procedure to place stent grafts, which function like tiny scaffolds, to improve blood flow in the leg arteries. It targets individuals suffering from chronic leg pain and poor circulation due to blockages in their leg arteries. Ideal participants have significant leg artery blockages affecting their daily activities, can undergo follow-up visits, and have not experienced recent severe infections or major health events like a stroke. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to innovative solutions for PAD.

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 prior data suggests that the PQ Bypass System is safe for peripheral arterial disease?

Research has shown that the PQ Bypass System is generally safe for people. One study found that after one year, the system was both safe and effective for treating patients with peripheral arterial disease. Another study indicated that it serves as a good alternative to traditional surgery, showing promising results in keeping blood vessels open. These studies suggest that the PQ Bypass System is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PQ Bypass System is unique because it offers a minimally invasive approach to treat peripheral arterial disease (PAD) by placing stent grafts in the peripheral vasculature to improve blood flow. Unlike traditional open surgery options, this system uses a catheter-based technique, which can potentially reduce recovery time and the risk of complications associated with more invasive procedures. Researchers are excited about this treatment because it could provide a safer and more efficient alternative for patients, making it a promising advancement in the management of PAD.

What evidence suggests that the PQ Bypass System is effective for Peripheral Arterial Disease?

Research has shown that the PQ Bypass System, which participants in this trial will receive, effectively treats peripheral arterial disease, particularly in the femoropopliteal (fem-pop) artery. One study found that the device kept the artery open in 72.1% of patients after 12 months, and 87.7% of patients did not need additional procedures to reopen the artery during this time. Another study found that 79% of patients had open arteries and 82% did not experience major complications over 24 months. These results suggest that the PQ Bypass System can safely and effectively improve blood flow in the affected arteries for many patients. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32276015/

One-year results from the DETOUR I trial of the PQ Bypass ... Through 1 month, there were no deaths or amputations; CD-TVRs occurred in 2 of 81 limbs (3%), and freedom from MAEs was 98% (79/81). The 1-year Kaplan-Meier ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0741521420304705

One-year results from the DETOUR I trial of the PQ Bypass ... The primary safety outcome was the 1-month MAE rate, defined as a composite end point of death, CD-TVR, or major target limb amputation. The primary ...

3. jvascsurg.org jvascsurg.org/article/S0741-5214(24)00307-0/fulltext

DETOUR2 trial outcomes demonstrate clinical utility of ... Primary patency was 72.1% and freedom from clinically driven target lesion revascularization was 87.7% through 12 months. Major adverse events, ...

4. evtoday.com evtoday.com/news/24-month-outcomes-presented-for-pq-bypass-detour-device

24-Month Outcomes Presented for PQ Bypass Detour Device The DETOUR I trial confirms the long-term efficacy and safety of endovascular bypass for the treatment of very long, complex femoropopliteal lesions.

5. serobavc.com serobavc.com/pq-bypass-releases-positive-24-month-data-from-the-detour1-clinical-trial/

PQ Bypass releases positive 24-month data from the ... PQ Bypass releases positive 24-month data from the DETOUR1 clinical trial · 79% primary patency · 82% freedom from major adverse events, inclusive ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220021B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The DETOUR™ System is contraindicated in patients with: • A distal common femoral artery (CFA) <7 mm in diameter. • Increased risk of deep vein ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03119233

Study Details | NCT03119233 | The DETOUR 2 Clinical Trial The PQ Bypass System is intended to improve blood flow in patients with symptomatic peripheral arterial disease due to symptomatic femoropopliteal chronic total ...

8. jvascsurg.org jvascsurg.org/article/S0741-5214(25)00680-9/fulltext

Real-World Experience with use of PQ Bypass for the ... Our real-world experience shows PQ bypass is a safe alternative to traditional endovascular and open surgical methods with a promising patency rate and a ...