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Stent Graft
PQ Bypass System for Peripheral Arterial Disease
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will continue to evaluate the safety and effectiveness of the PQ Bypass System for a percutaneous femoropopliteal bypass.
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.Check my eligibility
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.See study design
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 belowSelect...
My artery in the knee area is mostly unblocked.
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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.
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I have at least one open blood vessel below my knee with good blood flow to my ankle or foot.
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I am between 18 and 90 years old.
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I have chronic pain or sores on my legs due to poor blood flow.
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I had a blocked artery near the treatment area successfully cleared with no complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint - Patency at 12 Months
Primary Safety Endpoint at 30 Days
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.
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Who is running the clinical trial?
EndologixLead Sponsor
22 Previous Clinical Trials
3,902 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
642 Patients Enrolled for Peripheral Arterial Disease
PQ Bypass, Inc.Lead Sponsor
5 Previous Clinical Trials
550 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
550 Patients Enrolled for Peripheral Arterial Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had bypass surgery that affects the ability to perform procedures on my limb.Your venous clinical severity score is less than 3.My artery in the knee area is mostly unblocked.I have a major blockage in my heart that hasn't been effectively treated.I have not had a brain bleed, aneurysm, heart attack, or stroke in the last 3 months.I have a stent near the start of my superficial femoral artery.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.My kidney function is very low or I am on dialysis.My leg circulation issue is mild or I have severe tissue loss.I have at least one open blood vessel below my knee with good blood flow to my ankle or foot.I had a clot-busting procedure on a blood vessel within the last 3 days, but it didn't clear the clot completely.I have chronic pain or sores on my legs due to poor blood flow.I have a bleeding disorder or my blood doesn't clot properly.I am between 18 and 90 years old.Able to access the specific artery for the medical device to be inserted.I have no planned blood vessel procedures 14 days before or 30 days after joining.The blood vessel being studied is between 4.5 and 6.7 millimeters in diameter, as determined by the doctor's visual examination.I have had, or will have, a major part of my limb amputated.I have had a deep vein clot in the limb being studied.I have had thrombophlebitis in the last 30 days.I am allergic to the drugs or devices used in this study and cannot be safely treated for these allergies.I have an aneurysm or a recent clot in my limb.I am a good candidate for procedures to look at and fix blood vessels.I had a blocked artery near the treatment area successfully cleared with no complications.My severe obesity affects safe medical procedures or my ability to move.I do not have a severe infection or symptoms of a systemic inflammatory response.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the process of enrolling participants in this study still open?
"According to clinicaltrials.gov, this medical study is currently enrolling participants. The trial was first published on the 7th of April 2021 and its details were most recently edited on 28th September 2022."
Answered by AI
How many participants is the trial currently enrolling?
"This medical experiment requires 70 properly-qualified volunteers to participate. Potential participants can find a location near them, such as Sentara Norfolk in Virginia or The Vascular Experts in Connecticut."
Answered by AI
Is my eligibility to take part in this medical study still a possibility?
"This clinical trial requires that candidates be diagnosed with peripheral arterial disease, between the age of consent and 90 years old, and is seeking 70 participants in total."
Answered by AI
Is the population for this trial limited to individuals under 65 years of age?
"This trial is open to patients aged between 18 and 90 years old. 11 studies are accepting applicants younger than 18, while 210 additional studies welcome seniors over 65."
Answered by AI
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