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TORUS I Clinical Study | Clinical Trials | Clareo Health

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TORUS I Clinical Study

Long Segment Lesion Peripheral Artery Revascularization Feasibility Study

NCT03128424•Endologix

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.

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.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years and of age of legal consent.
•2. Women of child bearing potential must have a negative pregnancy test within 7 days prior to the index procedure.
•3. 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.
•4. A superficial femoral artery lesion with \>50% stenosis or occlusion which requires treatment.
•5. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≥ 120mm to \< 200mm.
•6. Reference vessel diameter (RVD) ≥ 5.0mm and ≤ 6.7 mm, angiographically/CTA/MRA defined.
•7. Patent popliteal artery 3 cm proximal to tibial plateau
•8. At least 1 patent tibial artery to the foot (\<50% stenosis)
•9. The target lesion(s) can be successfully crossed with a guide wire and dilated.
•10. 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.
+5 more criteria

Exclusion Criteria

•1. Age greater than 90
•2. Thrombophlebitis or deep venous thrombus, within the previous 30 days.
•3. Receiving dialysis or immunosuppressant therapy within the previous 30 days.
•4. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
•5. Stroke within the previous 90 days.
•6. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
•7. Required stent placement via a popliteal approach.
•8. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
•9. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
•10. Required stent placement within 1 cm of a previously deployed stent.
+17 more criteria

Key Dates

Start Date

February 1, 2016

Primary Completion Date

July 1, 2020

Completion Date

September 1, 2021

Last Updated

October 29, 2025

Enrollment

ACTUAL participants

Conditions

Peripheral Arterial Disease

Interventions

PQ Bypass Stent Graft System

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

NCT07161583

Peripheral Arterial Disease

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TORUS I Clinical Study

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)

Randomized Clinical Trial for Ewing Amputation in the VA