Peripheral Arterial DiseaseNCT03128424
TORUS I Clinical Study
A study testing PQ Bypass Stent Graft System in people with Peripheral Arterial Disease, run by Endologix.
Trial summary
The primary objective of the feasibility study is to evaluate the safety and effectiveness of the PQ Bypass Stent Graft System in the treatment of atherosclerotic lesions of the native superficial femoral artery (SFA) or the superficial femoral and proximal popliteal arteries. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- PQ Bypass Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and of age of legal consent.
- Women of child bearing potential must have a negative pregnancy test within 7 days prior to the index procedure.
- Subject has lifestyle limiting claudication or rest pain (Rutherford Becker scale 2-4) with a resting ABI < 0.9. Resting TBI is utilized only if unable to reliably assess ABI. TBI must be <0.7. These assessments are required for the target limb, but both limbs are preferred.
- A superficial femoral artery lesion with >50% stenosis or occlusion which requires treatment.
- Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≥ 120mm to < 200mm.
- Reference vessel diameter (RVD) ≥ 5.0mm and ≤ 6.7 mm, angiographically/CTA/MRA defined.
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- Patent popliteal artery 3 cm proximal to tibial plateau
- At least 1 patent tibial artery to the foot (<50% stenosis)
- The target lesion(s) can be successfully crossed with a guide wire and dilated.
- Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined >50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a successful treatment of the target lesion without prior treatment. Adequate aortoiliac or common femoral "inflow" is defined as <30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, the residual pressure gradient across the target lesion will be obtained and if the peak to peak pressure gradient is < 20mmHg, the subject will be included in the study.
- A subject with bilateral obstructive SFA disease is eligible for enrollment into the study. The contra-lateral procedure should not be done until at least 30 days after the index procedure (staged); however, if contra-lateral treatment is performed prior to treatment of the target lesion, the waiting period will be at least 30 days prior to the index procedure.
- The subject is eligible for standard surgical repair, if necessary.
- A subject who requires a coronary intervention should have it performed at least 30 days prior or 30 days post the treatment of the target lesion.
- Subject must provide written informed consent.
- Subject must be willing to comply with the specified follow-up evaluation schedule.
Who cannot join
- Age greater than 90
- Thrombophlebitis or deep venous thrombus, within the previous 30 days.
- Receiving dialysis or immunosuppressant therapy within the previous 30 days.
- Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
- Stroke within the previous 90 days.
- Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
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- Required stent placement via a popliteal approach.
- Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
- Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
- Required stent placement within 1 cm of a previously deployed stent.
- Known allergies to any of the following: aspirin and clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid ®),and prasugrel (Effient®); heparin; Nitinol (nickel titanium); or contrast agent, that cannot be medically managed.
- Presence of thrombus prior to crossing the lesion.
- Known or suspected active infection at the time of the procedure.
- Use of cryoplasty, laser, or atherectomy devices in the target vessel at the time of index procedure.
- Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
- History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be at risk for reoccurrence.
- Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that cannot be corrected.
- Subject has the following laboratory values: a. platelet count less than 80,000/μL, b. international normalized ratio (INR) greater than 1.5, c. serum creatinine level greater than 2.0 mg/dL.
- Subject requires general anesthesia for the procedure.
- Major distal amputation (above the transmetatarsal) in the study or non-study limb.
- Patient has had a revascularization procedure on the target limb within 30 days of the planned index procedure
- Patient has a planned amputation of the target limb
- Previous bypass surgery on the target limb
- Subject is pregnant or plans to become pregnant during the study.
- Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
- Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening other than a PQ Bypass study.
- NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now CE marked product are not excluded by this criterion.
About this study
Official title: Long Segment Lesion Peripheral Artery Revascularization Feasibility Study
The primary objective of the feasibility study is to evaluate the safety and effectiveness of the PQ Bypass Stent Graft System in the treatment of atherosclerotic lesions of the native superficial femoral artery (SFA) or the superficial femoral and proximal popliteal arteries.
Read the detailed description
The primary safety endpoint for this study is freedom from a major adverse event (MAE) at 30 days post-procedure. An MAE is defined as TLR, amputation of the treated limb or death.
The primary effectiveness endpoint is defined as stent patency as evidenced by a peak systolic velocity ratio (PSVR) < 2.5 from DUS obtained within the 12-month visit window with no clinically-driven re-intervention within the stented segment.
- Conditions
- Peripheral Arterial Disease
- Being tested
- PQ Bypass Stent Graft System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PQ Bypass Stent Graft SystemDevice
The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.
| Study group | Role | What they receive |
|---|---|---|
| PQ Bypass Stent Graft System | Experimental | The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA Receives: Device: PQ Bypass Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Freedom From a Major Adverse Event (MAE)
Freedom from a MAE as defined as target lesion revascularization (TLR), amputation of the treated limb or death.
Measured: 30 days
Primary Effectiveness
The primary effectiveness endpoint is defined as stent patency as evidenced by a peak systolic velocity ratio (PSVR) < 2.5 from DUS obtained within the 12- month visit window with no clinically driven re-intervention within the stented segment
Measured: 12 Month
Secondary outcomes (5)
Technical Success
Acute technical successdefined as : successful delivery, access and placement of the investigation devies and successful removal of the delivery system
Measured: Procedure
Lesion Success
Clinically Driven Target Lesion Revascularization (CD-TLR)
Measured: 12 months
Major Adverse Event (MAE) 6 Month
A Major Adverse Event (MAE) is defined as all cause mortality, target limb major amputation, and clinically driven target lesion revascularization (CD-TLR).
Measured: 6 months
Major Adverse Event (MAE) 12 Months
An MAE is defined as target lesion revascularization (TLR), amputation of the treated limb or death.
Measured: 12 month
TORUS Stent Fracture, Migration, and Separation
Stent Fracture, Migration, and Separation
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startFeb 2016
- Primary completionJul 2020
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PQ Bypass, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128424
- Sponsor's protocol ID
- STP 185
- Status last verified
- Oct 2025
- First submitted
- 29 Aug 2016
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Segment Lesion Peripheral Artery Revascularization Feasibility Study
- ClinicalTrials.gov ID
- NCT03128424
- Acronym / sponsor ID
- STP 185
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Collaborators
- PQ Bypass, Inc.
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the feasibility study is to evaluate the safety and effectiveness of the PQ Bypass Stent Graft System in the treatment of atherosclerotic lesions of the native superficial femoral artery (SFA) or the superficial femoral and proximal popliteal arteries.
Detailed description
The primary safety endpoint for this study is freedom from a major adverse event (MAE) at 30 days post-procedure. An MAE is defined as TLR, amputation of the treated limb or death.
The primary effectiveness endpoint is defined as stent patency as evidenced by a peak systolic velocity ratio (PSVR) < 2.5 from DUS obtained within the 12-month visit window with no clinically-driven re-intervention within the stented segment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PQ Bypass Stent Graft System | Experimental | Device: PQ Bypass Stent Graft SystemThe PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years and of age of legal consent.
- Women of child bearing potential must have a negative pregnancy test within 7 days prior to the index procedure.
- Subject has lifestyle limiting claudication or rest pain (Rutherford Becker scale 2-4) with a resting ABI < 0.9. Resting TBI is utilized only if unable to reliably assess ABI. TBI must be <0.7. These assessments are required for the target limb, but both limbs are preferred.
- A superficial femoral artery lesion with >50% stenosis or occlusion which requires treatment.
- Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≥ 120mm to < 200mm.
Key exclusion criteria (27 listed)
- Age greater than 90
- Thrombophlebitis or deep venous thrombus, within the previous 30 days.
- Receiving dialysis or immunosuppressant therapy within the previous 30 days.
- Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
- Stroke within the previous 90 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PQ Bypass Stent Graft SystemThe PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm. | Device | PQ Bypass Stent Graft System |
Primary outcome
Number of Participants With Freedom From a Major Adverse Event (MAE)
Time frame: 30 days
Freedom from a MAE as defined as target lesion revascularization (TLR), amputation of the treated limb or death.
Primary Effectiveness
Time frame: 12 Month
The primary effectiveness endpoint is defined as stent patency as evidenced by a peak systolic velocity ratio (PSVR) < 2.5 from DUS obtained within the 12- month visit window with no clinically driven re-intervention within the stented segment
5 secondary outcomes
Technical Success
Time frame: Procedure
Lesion Success
Time frame: 12 months
Major Adverse Event (MAE) 6 Month
Time frame: 6 months
Major Adverse Event (MAE) 12 Months
Time frame: 12 month
TORUS Stent Fracture, Migration, and Separation
Time frame: 12 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PQ Bypass Stent Graft System in people with Peripheral Arterial Disease, run by Endologix.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Freedom From a Major Adverse Event (MAE) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.