Clinical trial NCT04130737: TORUS 2 IDE Clinical Study
Official title: The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Artery Disease
Superficial Femoral Artery
Popliteal Artery
Stent Graft
Lead sponsor: Endologix
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
name: PQ Bypass, Inc.
First posted: 2019-10-17
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Freedom from a Major Adverse Event (MAE)
timeFrame: 30 days
measure: Primary Patency
timeFrame: 12 months
Secondary outcomes:
measure: Technical Success
timeFrame: At the time of the index procedure
measure: Procedural Success
timeFrame: Within 24 hours of the procedure
measure: Major Adverse Event (MAE) Rate
timeFrame: 12 months
measure: Patency Rate
timeFrame: Through 36 months
measure: Assisted Primary Patency Rate
timeFrame: Through 36 months
measure: Secondary Patency Rate
timeFrame: Through 36 months
measure: Alternative Patency Rate
timeFrame: Through 36 months
measure: Walking Improvement Questionnaire (WIQ) Assessment
timeFrame: From procedure to 1, 6 and 12 months
measure: Quality of Life Assessment by the EQ5D
timeFrame: From procedure to 1, 6 and 12 months
measure: Clinically Driven Target Lesion Revascularization
timeFrame: Through 36 months
measure: Target Vessel Revascularization
timeFrame: Through 36 months
measure: Major Amputation on Target Limb
timeFrame: Through 36 months
measure: Stent Fracture Rate
timeFrame: 12 months
measure: Change in Ankle-Brachial Index
timeFrame: From procedure through 36 months
measure: Change in Toe Pressures
timeFrame: From procedure through 36 months
measure: Change in Rutherford Clinical Classification
timeFrame: From procedure through 36 months
measure: Adverse Event Rate
timeFrame: Through 36 months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Southwest CVA
state: Arizona
city: Mesa
country: United States
facility: Vascular Heart & Lung Associates
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Yuma
country: United States
facility: Yuma Cardiology Associates
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart
state: Arkansas
city: Burlingame
country: United States
facility: Bay Area Vein & Vascular Institute
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VAMC
state: Colorado
city: Darien
country: United States
facility: The Vascular Experts
state: Connecticut
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Miami Beach
country: United States
facility: Palm Vascular Centers
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular & Interventional
state: Florida
city: Winter Park
country: United States
facility: Florida Cardiology
state: Florida
city: Elk Grove
country: United States
facility: AMITA Health
state: Illinois
city: Hyattsville
country: United States
facility: MedStar Health Research Insitute
state: Maryland
city: Bay City
country: United States
facility: McLaren Bay Region
state: Michigan
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: Roseville
country: United States
facility: Eastlake Cardiovascular
state: Michigan
city: Tupelo
country: United States
facility: Northern Mississippi Medical Center
state: Mississippi
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Novant Health
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart & Vascular Research
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center for Research & Education
state: Ohio
city: Oklahoma City
country: United States
facility: Naadi
state: Oklahoma
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central Heart
state: South Dakota
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation
state: Tennessee
city: Lubbock
country: United States
facility: Texas Tech
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Green Bay
country: United States
facility: Bellin Hospital
state: Wisconsin
Study officials:
References: