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PQ Bypass for Peripheral Arterial Disease
Study Summary
This trial will test the safety and effectiveness of a new system for creating a bypass around blocked arteries in the leg.
- Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You are planning to have a big or small amputation on the leg being studied in the trial.You have had an amputation on the lower part of your leg.You are very obese and it's not safe to use veins for medical procedures or imaging.You have an ongoing or suspected infection when the procedure is scheduled.You are in Rutherford clinical categories 0, 1, 2, or 6.You have severe kidney disease with very low kidney function or high levels of waste in your blood.You have had a blood clot in a deep vein in your leg before.You had a condition called thrombophlebitis in the last 30 days.You have a known blood clotting problem, low platelet count, or high INR level.You need to have a heart or blood vessel procedure within 30 days before or after the treatment for the specific medical condition being studied.You have had a brain bleed, aneurysm, heart attack, or stroke in the past 3 months.You have a stent placed within 3 cm of the ostium of the SFA (superficial femoral artery).You have had surgery to redirect blood flow in the same limb.You have a blockage of at least 50% in the inflow tract that hasn't been fixed yet.You have a bulging blood vessel or a recent blood clot in the limb being studied.If you had a procedure to break up a blood clot in a specific blood vessel within the last 72 hours, and the clot didn't completely go away, you cannot participate in the study.You are between 18 and 90 years old.You have long-term, painful leg circulation problems categorized as Rutherford clinical categories 3, 4, or 5.You have a venous clinical severity score of less than 3.You are able to undergo angiography, endovascular intervention, and, if needed, standard surgical repair.You have long and severe blockages in the arteries of your legs, as determined by the doctor's examination.The size of the blood vessel where the treatment will be done is between 4.5 and 6.7 millimeters as measured by the doctor.The subject has a clear popliteal artery with less than 50% blockage below the treatment area.The doctor can easily reach the starting point in the artery for the medical device.You have at least one narrow blood vessel below the knee with blood flow to the ankle or foot.You have a blockage or narrowing of an artery that needs to be treated before the study treatment can be given.
- Group 1: Single-Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is the age restriction for this clinical experiment limited to adults?
"This medical trial has a narrow age range of 18-90, with 11 separate trials available for those under the legal age and 209 studies designed to cater to individuals over 65."
Is there still availability for participants in this experiment?
"According to the clinicaltrials.gov website, this clinical trial is no longer looking for participants since its last update on July 29th 2022. While recruitment has ended, there are still 216 other studies actively seeking enrollees at present time."
How widespread is the implementation of this research project?
"As of now, 31 medical centres are recruiting for this clinical trial. These include the First Coast Cardiovascular Institute in Jacksonville, Arkansas Heart Hospital in Little Rock, and Bay Area Vein and Vascular in Burlingame; a further 28 locations also have active recruitment."
Who would be a prime candidate for taking part in this research?
"For this clinical trial to be effective, 202 participants must meet certain criteria; they should fall between 18-90 years of age, present a Venous Clinical Severity Score lower than 3, and exhibit chronic symptoms of lower limb ischemia (Rutherford clinical categories 3, 4 or 5). Furthermore, the subject needs to agree with follow-up assessments over 36 months, as well as being suitable for angiography and endovascular intervention if necessary. The lesion in question also has to exceed 20 cm according to TASC D classification or 24 cm under complex TASC C conditions."
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