TORUS 2 IDE Clinical Study

• ClinicalTrials.gov Identifier: NCT04130737
• Recruitment Status: Active, not recruiting
• First Posted: October 17, 2019
• Last Update Posted: March 7, 2024
• Sponsor: Endologix
• Collaborators: Syntactx; PQ Bypass, Inc.
• Information provided by (Responsible Party): Endologix

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Device: TORUS Stent Graft System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 188 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2
• Actual Study Start Date: October 31, 2019
• Actual Primary Completion Date: January 6, 2023
• Estimated Study Completion Date: December 24, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Freedom from a Major Adverse Event (MAE) [ Time Frame: 30 days ]
   An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)
2. Primary Patency [ Time Frame: 12 months ]
   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.

Secondary Outcome Measures :

1. Technical Success [ Time Frame: At the time of the index procedure ]
   Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30%
2. Procedural Success [ Time Frame: Within 24 hours of the procedure ]
   Procedural Success is defined as technical success with out any MAEs.
3. Major Adverse Event (MAE) Rate [ Time Frame: 12 months ]
   Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR).
4. Patency Rate [ Time Frame: Through 36 months ]
   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.
5. Assisted Primary Patency Rate [ Time Frame: Through 36 months ]
   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.
6. Secondary Patency Rate [ Time Frame: Through 36 months ]
   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.)
7. Alternative Patency Rate [ Time Frame: Through 36 months ]
   Patency of target vessel based on systolic velocity ratio ≤ 2.0 and absence of CD-TLR.
8. Walking Improvement Questionnaire (WIQ) Assessment [ Time Frame: From procedure to 1, 6 and 12 months ]
   Assessment of walking improvement
9. Quality of Life Assessment by the EQ5D [ Time Frame: From procedure to 1, 6 and 12 months ]
   Assessment of improved quality of life
10. Clinically Driven Target Lesion Revascularization [ Time Frame: Through 36 months ]
11. Target Vessel Revascularization [ Time Frame: Through 36 months ]
12. Major Amputation on Target Limb [ Time Frame: Through 36 months ]
13. Stent Fracture Rate [ Time Frame: 12 months ]
    Stent fracture rate using VIVA definitions
14. Change in Ankle-Brachial Index [ Time Frame: From procedure through 36 months ]
15. Change in Toe Pressures [ Time Frame: From procedure through 36 months ]
16. Change in Rutherford Clinical Classification [ Time Frame: From procedure through 36 months ]
17. Adverse Event Rate [ Time Frame: Through 36 months ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Arizona

Southwest CVA

Mesa, Arizona, United States, 85206

Vascular Heart & Lung Associates

Mesa, Arizona, United States, 85206

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States, 85018

Yuma Cardiology Associates

Yuma, Arizona, United States, 85349

United States, Arkansas

Arkansas Heart

Little Rock, Arkansas, United States, 72211

United States, California

Bay Area Vein & Vascular Institute

Burlingame, California, United States, 94010

UCSF

San Francisco, California, United States, 94143

United States, Colorado

Rocky Mountain Regional VAMC

Aurora, Colorado, United States, 80045

United States, Connecticut

The Vascular Experts

Darien, Connecticut, United States, 06820

United States, Florida

First Coast Cardiovascular Institute

Jacksonville, Florida, United States, 32256

Palm Vascular Centers

Miami Beach, Florida, United States, 33140

Coastal Vascular & Interventional

Pensacola, Florida, United States, 32504

Florida Cardiology

Winter Park, Florida, United States, 32792

United States, Illinois

AMITA Health

Elk Grove, Illinois, United States, 60007

United States, Maryland

MedStar Health Research Insitute

Hyattsville, Maryland, United States, 20782

United States, Michigan

McLaren Bay Region

Bay City, Michigan, United States, 48708

Michigan Vascular Center

Flint, Michigan, United States, 48507

Eastlake Cardiovascular

Roseville, Michigan, United States, 48066

United States, Mississippi

Northern Mississippi Medical Center

Tupelo, Mississippi, United States, 38801

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

United States, North Carolina

Novant Health

Charlotte, North Carolina, United States, 28204

NC Heart & Vascular Research

Raleigh, North Carolina, United States, 27607

United States, Ohio

The Lindner Center for Research & Education

Cincinnati, Ohio, United States, 45219

United States, Oklahoma

Naadi

Oklahoma City, Oklahoma, United States, 73116

United States, Rhode Island

The Miriam Hospital

Providence, Rhode Island, United States, 02906

United States, South Carolina

Prisma Health

Greenville, South Carolina, United States, 29615

United States, South Dakota

North Central Heart

Sioux Falls, South Dakota, United States, 57108

United States, Tennessee

Stern Cardiovascular Foundation

Germantown, Tennessee, United States, 38138

United States, Texas

Texas Tech

Lubbock, Texas, United States, 79430

North Dallas Research Associates

McKinney, Texas, United States, 75069

United States, Virginia

Sentara Vascular Specialists

Norfolk, Virginia, United States, 23507

United States, Wisconsin

Bellin Hospital

Green Bay, Wisconsin, United States, 54301

Sponsors and Collaborators

Endologix

Syntactx

PQ Bypass, Inc.

More Information

• Responsible Party: Endologix
• ClinicalTrials.gov Identifier: NCT04130737
• Other Study ID Numbers: CLN 227
• First Posted: October 17, 2019
• Last Update Posted: March 7, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Endologix:

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

Additional relevant MeSH terms:

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