Peripheral Arterial Disease
Conditions
Keywords
Peripheral Artery Disease, Superficial Femoral Artery, Popliteal Artery, Stent Graft
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.
Detailed description
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
Interventions
DEVICETORUS 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.
Sponsors
Endologix
Syntactx
PQ Bypass, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From a Major Adverse Event (MAE) | 30 days | An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) |
| Primary Patency | 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
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | 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% |
| Procedural Success | Within 24 hours of the procedure | Procedural Success is defined as technical success with out any MAEs. |
| Major Adverse Event (MAE) Rate | 12 months | Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR). |
| Major Amputation on Target Limb | Through 36 months | 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 |
| Patency Rate | Through 12 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. |
| Clinically Driven Target Lesion Revascularization | Through 36 months | 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 |
| Walking Improvement Questionnaire (WIQ) Assessment | Change from baseline to 12-Month follow-up (Collected at 1M,6M, and 12M) | 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 |
| Quality of Life Assessment by the EQ5D VAS | Change from baseline to 12-Month follow-up (Collected at 1M, 6M, and 12M) | 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) |
| Stent Fracture Rate | 12 months | Stent fracture rate using VIVA definitions |
| Change in Ankle-Brachial Index | Change from Baseline through 36 months | 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 |
| Change in Toe Pressures | Change from Baseline through 36 months | 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 |
| Change in Rutherford Clinical Classification | From procedure through 36 months | Clinical success: improvement in ≥ 1 Rutherford class |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREhrin Armstrong,, MD
Denver Veteran's Administration Hospital
PRINCIPAL_INVESTIGATORPeter Schneider,, MD
University of California
Participant flow
Pre-assignment details
The TORUS 1 clinical study was conducted in Germany and Latvia and enrolled a total of 60 subjects. Subject enrollment for TORUS 1 was closed on July 1, 2019. As per the TORUS 2 Statistical Analysis Plan (SAP) version 2, the last 30 subjects enrolled in TORUS 1 study are included in the endpoint analysis for the TORUS 2 study. Subject 30 in the TORUS 1 study was rolled-over into the TORUS 2 cohort, and was enrolled on August 13, 2018.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 8.4 |
| Diabetes Mellitus | 94 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| History of CAD | 96 Participants |
| History of Hyperlipidemia | 136 Participants |
| History of Hypertension | 170 Participants |
| History of MI | 35 Participants |
| History of Peripheral Intervention | 95 Participants |
| History of Peripheral Vascular Surgery | 25 Participants |
| History of Renal Insufficiency | 32 Participants |
| History of Smoking | 153 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 130 Participants |
| Region of Enrollment Europe | 30 Participants |
| Region of Enrollment United States | 158 Participants |
| Rutherford Classification 0 | 0 Participants |
| Rutherford Classification 1 | 0 Participants |
| Rutherford Classification 2 | 30 Participants |
| Rutherford Classification 3 | 106 Participants |
| Rutherford Classification 4 | 51 Participants |
| Rutherford Classification 5 | 1 Participants |
| Rutherford Classification 6 | 0 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 24 / 188 |
| other Total, other adverse events | 136 / 188 |
| serious Total, serious adverse events | 85 / 188 |
Outcome results
None listed