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Stent Graft

PQ Bypass for Peripheral Arterial Disease

N/A
Waitlist Available
Led By Sean Lyden, MD
Research Sponsored by PQ Bypass, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 and ≤ 90 years of age
Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new system for creating a bypass around blocked arteries in the leg.

Eligible Conditions
  • Peripheral Arterial Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 90 years old.
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You have long-term, painful leg circulation problems categorized as Rutherford clinical categories 3, 4, or 5.
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You are able to undergo angiography, endovascular intervention, and, if needed, standard surgical repair.
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The subject has a clear popliteal artery with less than 50% blockage below the treatment area.
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The doctor can easily reach the starting point in the artery for the medical device.
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You have at least one narrow blood vessel below the knee with blood flow to the ankle or foot.
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You have a blockage or narrowing of an artery that needs to be treated before the study treatment can be given.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint
Primary Safety Endpoint

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.

Find a Location

Who is running the clinical trial?

PQ Bypass, Inc.Lead Sponsor
5 Previous Clinical Trials
400 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
400 Patients Enrolled for Peripheral Arterial Disease
Sean Lyden, MDPrincipal InvestigatorThe Cleveland Clinic
8 Previous Clinical Trials
2,683 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
1,100 Patients Enrolled for Peripheral Arterial Disease
Jihad Mustapha, MDPrincipal InvestigatorAdvanced Cardiac and Vascular Amputation Prevention Centers
8 Previous Clinical Trials
2,783 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
883 Patients Enrolled for Peripheral Arterial Disease

Media Library

PQ Bypass System (Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT03119233 — N/A
Peripheral Arterial Disease Research Study Groups: Single-Arm
Peripheral Arterial Disease Clinical Trial 2023: PQ Bypass System Highlights & Side Effects. Trial Name: NCT03119233 — N/A
PQ Bypass System (Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03119233 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~30 spots leftby Mar 2025