Trial Outcomes & Findings for The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study (NCT NCT04130737)

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.

A total of 188 subjects (TORUS 2: 158 and TORUS 1: 30) were enrolled. Ethnicity not collected for TORUS 1 subjects.

An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)

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.

Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30%

Procedural Success is defined as technical success with out any MAEs.

Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR).

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

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 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 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

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 using VIVA definitions

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-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

Clinical success: improvement in ≥ 1 Rutherford class