TORUS 2 IDE Clinical Study

The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2

The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: TORUS Stent Graft System

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Southwest CVA
    • Mesa, Arizona, United States, 85206
      • Vascular Heart & Lung Associates
    • Phoenix, Arizona, United States, 85018
      • Phoenix Cardiovascular Research Group
    • Yuma, Arizona, United States, 85349
      • Yuma Cardiology Associates
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart
  • California
    • Burlingame, California, United States, 94010
      • Bay Area Vein & Vascular Institute
    • San Francisco, California, United States, 94143
      • UCSF
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VAMC
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • The Vascular Experts
  • Florida
    • Jacksonville, Florida, United States, 32256
      • First Coast Cardiovascular Institute
    • Miami Beach, Florida, United States, 33140
      • Palm Vascular Centers
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular & Interventional
    • Winter Park, Florida, United States, 32792
      • Florida Cardiology
  • Illinois
    • Elk Grove, Illinois, United States, 60007
      • AMITA Health
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Insitute
  • Michigan
    • Bay City, Michigan, United States, 48708
      • McLaren Bay Region
    • Flint, Michigan, United States, 48507
      • Michigan Vascular Center
    • Roseville, Michigan, United States, 48066
      • Eastlake Cardiovascular
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Northern Mississippi Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health
    • Raleigh, North Carolina, United States, 27607
      • NC Heart & Vascular Research
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Center for Research & Education
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Naadi
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular Foundation
  • Texas
    • Lubbock, Texas, United States, 79430
      • Texas Tech
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Vascular Specialists
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Bellin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient is male or female, with age > 18 and ≤ 90 years at date of enrollment.
2. Patient provides written informed consent before any study-specific investigations or procedures.
3. Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
4. Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
5. Patient has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion or restenosis of the native femoropopliteal artery.
6. Patient has PAD classified as Rutherford classification 2, 3 or 4.
7. Patient has documented PAD by either (i) a resting ankle-brachial index (ABI) of ≤ 0.90 (or ≤ 0.75 after exercise of the target limb). Resting toe brachial index (TBI) is performed only if unable to reliably assess ABI. TBI must be <0.70; or (ii) Normal ABI with angiographic, ultrasound, MRA, or CT evidence of ≥ 60% diameter stenosis.
8. Patient has single or multiple stenotic, restenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.
9. Single target lesion must be covered by a single stent. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and > 30% diameter stenosis between the lesion(s).
10. Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur.
11. Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate.
12. Target lesion measures ≥ 80 mm to ≤ 180 mm in overall length, with ≥ 60% diameter stenosis by operator's visual estimate. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and > 30% diameter stenosis between the lesion(s).
13. Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment.
14. Patient has at least one patent infrapopliteal vessel (< 50% stenosis) with run-off to the ankle.

Exclusion Criteria:

1. Patient is unable or is unwilling to comply with the procedural requirements of the study protocol or will have difficulty in complying with the requirements for attending follow-up visits.
2. Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months.
3. Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.
4. Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.
5. Patient has a target vessel that has been treated with bypass surgery.
6. Patient has PAD classified as Rutherford classification 0, 1, 5 or 6.
7. Patient has known or suspected active systemic infection at the time of enrollment.
8. Patient has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR (international normalized ratio) >1.8.
9. Patient has a stroke diagnosis within three months prior to enrollment.
10. Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
11. Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.
12. Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.
13. Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy).
14. Patient has received thrombolysis within 72 hours prior to the index procedure.
15. Patient has acute or chronic renal disease (e.g., as measured by a serum creatinine of > 2.5 mg/dL or > 220 μmol/L or GFR < 30 ml/min), or on peritoneal or hemodialysis.
16. Patient requiring coronary intervention within seven days prior to enrollment.
17. Patient is pregnant or breast-feeding.
18. Patient is participating in another research study involving an investigational product (pharmaceutical, biologic or medical device).
19. Patient has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
20. Patient has significant disease or obstruction (≥ 50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤ 30% residual stenosis, without complication).
21. Patient has no patent (≥ 50% stenosis) outflow vessel providing run-off to the ankle.
22. There is a lack of full expansion in the predilatation balloon.
23. Evidence of aneurysm or acute thrombus in target vessel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TORUS Stent Graft System; The TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS).

Device: TORUS Stent Graft System; The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.; Other Names: TORUS Stent Graft; PQ Bypass™ Stent Graft System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from a Major Adverse Event (MAE)	An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)	30 days
Primary Patency	Primary patency is defined as the absence of clinically-driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30%	At the time of the index procedure
Procedural Success	Procedural Success is defined as technical success with out any MAEs.	Within 24 hours of the procedure
Major Adverse Event (MAE) Rate	Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR).	12 months
Patency Rate	Absence of CD-TLR and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5.	Through 36 months
Assisted Primary Patency Rate	Revascularization of non-occlusive (<99%) stenosis within the stent graft or immediately above or below the treated arterial segment (end of the graft and 1cm of artery beyond) with less than 50% residual stenosis.	Through 36 months
Secondary Patency Rate	Revascularization of occlusion (100%) within the stent graft or immediately above or below the treated arterial segment (end of the graft and 1cm of artery beyond) with less than 50% residual stenosis.)	Through 36 months
Alternative Patency Rate	Patency of target vessel based on systolic velocity ratio ≤ 2.0 and absence of CD-TLR.	Through 36 months
Walking Improvement Questionnaire (WIQ) Assessment	Assessment of walking improvement	From procedure to 1, 6 and 12 months
Quality of Life Assessment by the EQ5D	Assessment of improved quality of life	From procedure to 1, 6 and 12 months
Clinically Driven Target Lesion Revascularization		Through 36 months
Target Vessel Revascularization		Through 36 months
Major Amputation on Target Limb		Through 36 months
Stent Fracture Rate	Stent fracture rate using VIVA definitions	12 months
Change in Ankle-Brachial Index		From procedure through 36 months
Change in Toe Pressures		From procedure through 36 months
Change in Rutherford Clinical Classification		From procedure through 36 months
Adverse Event Rate		Through 36 months

Collaborators and Investigators

• Sponsor: Endologix
• Collaborators: PQ Bypass, Inc.; Syntactx

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Actual): January 6, 2023
• Study Completion (Estimated): December 24, 2024

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Superficial Femoral Artery; Stent Graft; Popliteal Artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CLN 227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes