TORUS 2 IDE Clinical Study

NCT04130737 | Active Not Recruiting FDA Device

• 1 other identifier: CLN 227
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 32

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Artery Disease; Superficial Femoral Artery; Popliteal Artery; Stent Graft

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Technical Success

  At the time of the index procedure

• Procedural Success

  Within 24 hours of the procedure

• Major Adverse Event (MAE) Rate

  12 months

• Patency Rate

  Through 36 months

• Assisted Primary Patency Rate

  Through 36 months

Study Arms (1)

TORUS Stent Graft System

EXPERIMENTAL

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

Interventions

TORUS Stent Graft System DEVICE

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.

Also known as: TORUS Stent Graft, PQ Bypass™ Stent Graft System

TORUS 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:

• Patient is male or female, with age \> 18 and ≤ 90 years at date of enrollment.
• Patient provides written informed consent before any study-specific investigations or procedures.
• Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
• Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
• 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.
• Patient has PAD classified as Rutherford classification 2, 3 or 4.
• 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.
• 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.
• 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).
• Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur.
• Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate.
• 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).
• Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment.
• Patient has at least one patent infrapopliteal vessel (\< 50% stenosis) with run-off to the ankle.

You may not qualify if:

• 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.
• Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months.
• Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.
• Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.
• Patient has a target vessel that has been treated with bypass surgery.
• Patient has PAD classified as Rutherford classification 0, 1, 5 or 6.
• Patient has known or suspected active systemic infection at the time of enrollment.
• 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.
• Patient has a stroke diagnosis within three months prior to enrollment.
• Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
• Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.
• Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.
• Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy).
• Patient has received thrombolysis within 72 hours prior to the index procedure.
• 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.

Sponsors & Collaborators

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

Study Sites (32)

Southwest CVA

Mesa, Arizona, 85206, United States

Location

Vascular Heart & Lung Associates

Mesa, Arizona, 85206, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

Yuma Cardiology Associates

Yuma, Arizona, 85349, United States

Location

Arkansas Heart

Little Rock, Arkansas, 72211, United States

Location

Bay Area Vein & Vascular Institute

Burlingame, California, 94010, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Rocky Mountain Regional VAMC

Aurora, Colorado, 80045, United States

Location

The Vascular Experts

Darien, Connecticut, 06820, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Palm Vascular Centers

Miami Beach, Florida, 33140, United States

Location

Coastal Vascular & Interventional

Pensacola, Florida, 32504, United States

Location

Florida Cardiology

Winter Park, Florida, 32792, United States

Location

AMITA Health

Elk Grove, Illinois, 60007, United States

Location

MedStar Health Research Insitute

Hyattsville, Maryland, 20782, United States

Location

McLaren Bay Region

Bay City, Michigan, 48708, United States

Location

Michigan Vascular Center

Flint, Michigan, 48507, United States

Location

Eastlake Cardiovascular

Roseville, Michigan, 48066, United States

Location

Northern Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Novant Health

Charlotte, North Carolina, 28204, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

The Lindner Center for Research & Education

Cincinnati, Ohio, 45219, United States

Location

Naadi

Oklahoma City, Oklahoma, 73116, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Prisma Health

Greenville, South Carolina, 29615, United States

Location

North Central Heart

Sioux Falls, South Dakota, 57108, United States

Location

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Texas Tech

Lubbock, Texas, 79430, United States

Location

North Dallas Research Associates

McKinney, Texas, 75069, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Bellin Hospital

Green Bay, Wisconsin, 54301, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

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: October 10, 2019
• First Posted: October 17, 2019
• Study Start: October 31, 2019
• Primary Completion: January 6, 2023
• Study Completion: December 24, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)