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.
Peripheral Arterial Disease, specifically in the superficial femoral arteries (SFA) and proximal popliteal arteries, are treated by a range of alternative practices and procedures for the patient population identified in the indications for use statement. Non-invasive approaches include exercise and drug therapy. Minimally-invasive approaches include endovascular intervention using percutaneous transluminal angioplasty using a plain or drug-coated balloon, stents (bare metal, drug-eluting and covered) and various modalities of atherectomy. SFA Stent Graft Systems have a clinical history that demonstrates that this device type is well understood, and the benefits and risks are well-characterized, i.e. mature technology. Endologix believes that the clinical performance of the TORUS stent would be comparable to marketed SFA Stent Graft System. The TORUS 2 IDE Clinical Study will confirm this and is designed to demonstrate the safety and effectiveness of the TORUS Stent Graft System in patients with SFA and/or proximal popliteal artery disease
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
188
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.
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)
Time frame: 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.
Time frame: 12 months
Technical Success
Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30%
Time frame: At the time of the index procedure
Procedural Success
Procedural Success is defined as technical success with out any MAEs.
Time frame: 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).
Time frame: 12 months
Major Amputation on Target Limb
Major Amputation on Target Limb were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months
Time frame: Through 36 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.
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Southwest CVA
Mesa, Arizona, United States
Vascular Heart & Lung Associates
Mesa, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Yuma Cardiology Associates
Yuma, Arizona, United States
Arkansas Heart
Little Rock, Arkansas, United States
Bay Area Vein & Vascular Institute
Burlingame, California, United States
UCSF
San Francisco, California, United States
Rocky Mountain Regional VAMC
Aurora, Colorado, United States
The Vascular Experts
Darien, Connecticut, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
...and 22 more locations
Time frame: Through 12 months
Clinically Driven Target Lesion Revascularization
Clinically Driven Target Lesion Revascularization were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months
Time frame: Through 36 months
Walking Improvement Questionnaire (WIQ) Assessment
Walking Impairment Questionnaire (WIQ) - The WIQ is a patient-reported outcome measure that assesses self-reported walking ability in individuals with peripheral arterial disease (PAD). It evaluates perceived difficulty performing walking tasks related to walking distance, walking speed, and stair climbing, which reflect functional limitations caused by PAD. Scale Structure and Scoring: The WIQ consists of three subscales: Walking Distance Walking Speed Stair Climbing Each subscale is scored from 0 to 100, where higher scores indicate better walking function. The Composite PAD Score (PADSCORE) is calculated by averaging the three subscale scores, resulting in a total composite score ranging from 0 to 100. Scale Ranges and Interpretation: WIQ Subscale Scores: 0 (worst function) to 100 (best function) WIQ Composite PAD Score: 0 (worst walking impairment) to 100 (no walking impairment) Direction of Outcome: For all WIQ scores, higher values represent a better outcome
Time frame: Change from baseline to 12-Month follow-up (Collected at 1M,6M, and 12M)
Quality of Life Assessment by the EQ5D VAS
EuroQol Visual Analog Scale (EQ-5D-VAS) - The EQ-5D-VAS is a patient-reported outcome measure that assesses overall self-rated health-related quality of life. Participants rate their current health status using a visual analog scale anchored by the best and worst imaginable health states. Scale Structure and Scoring: Participants mark their perceived health status on a vertical visual analog scale. Scale Range and Interpretation: EQ-5D-VAS Score Range: 0 to 100 0: Worst imaginable health state (minimum) 100: Best imaginable health state (maximum) Direction of Outcome: Higher EQ-5D-VAS scores represent a better outcome, reflecting better perceived health-related quality of life. Lower scores indicate worse perceived health status. Unit of Measure: EQ-5D-VAS (scores on a scale)
Time frame: Change from baseline to 12-Month follow-up (Collected at 1M, 6M, and 12M)
Stent Fracture Rate
Stent fracture rate using VIVA definitions
Time frame: 12 months
Change in Ankle-Brachial Index
Change in Ankle-Brachial Index (ABI) in study subjects from baseline to each study interval through follow-up. Scale Structure and Scoring: Change in ABI was calculated as the difference between post-baseline ABI and baseline ABI for each participant for the target limb. ABI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Therefore, interpretation is based on clinically established thresholds rather than absolute scale limits: ABI ≤ 0.90: Consistent with peripheral arterial disease ABI 0.91-1.29: Generally considered normal arterial perfusion ABI ≥ 1.30: Suggestive of non-compressible arteries (e.g., arterial calcification) Change in ABI: Positive change (increase): Improvement in lower-extremity perfusion Negative change (decrease): Worsening arterial perfusion Direction of Outcome: For Change in ABI, higher (more positive) values represent a better outcome
Time frame: Change from Baseline through 36 months
Change in Toe Pressures
Change in Toe-Brachial Index (TBI) in study subjects from baseline to each study interval through follow-up for the target limb. If ABI could not be assessed the TBI was assessed. Scale Structure and Scoring: TBI is calculated as: TBI = Toe systolic blood pressure ÷ Brachial systolic blood pressure Change in TBI was calculated as the difference between post-baseline TBI and baseline TBI for each participant. Scale Range and Clinical Interpretation: TBI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Interpretation is therefore based on clinically established thresholds rather than absolute scale limits: TBI \< 0.70: Consistent with peripheral arterial disease TBI ≥ 0.70: Generally considered normal digital perfusion For Change in TBI: A positive change (increase) indicates improvement in distal (digital) perfusion A negative change (decrease) indicates worsening arterial perfusion
Time frame: Change from Baseline through 36 months
Change in Rutherford Clinical Classification
Clinical success: improvement in ≥ 1 Rutherford class
Time frame: From procedure through 36 months