TORUS I Clinical Study

NCT03128424 | Completed Results DMC FDA Device

• 1 other identifier: STP 185
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  12 Month

Secondary Outcomes (5)

• Technical Success

  Procedure

• Lesion Success

  12 months

• Major Adverse Event (MAE) 6 Month

  6 months

• Major Adverse Event (MAE) 12 Months

  12 month

• TORUS Stent Fracture, Migration, and Separation

  12 Month

Study Arms (1)

PQ Bypass Stent Graft System

EXPERIMENTAL

The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA

Device: PQ Bypass Stent Graft System

Interventions

PQ Bypass Stent Graft System DEVICE

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.

PQ Bypass Stent Graft System

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Endologix: lead
• PQ Bypass, Inc.: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Mohamed Moawad
• Organization: Endologix

mmoawad@endologix.com

949-595-7244

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: April 25, 2017
• Study Start: February 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2021
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share