BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease

Freedom from major adverse events (MAEs) defined as: Target Vessel Revascularization; Device and/or procedure related death; Major amputation of target limb; Pulmonary Embolism which is clinically important; Vascular injury requiring surgical/endovascular intervention; Embolization /migration of stent; Device or procedure related acute DVT involving the treated limb. Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.

Time frame: 30 days post-index procedure

Population: ITT subjects. Results adjudicated by CEC. MAEs that occurred prior to day 30 of each subject's follow-up were counted as failures toward primary safety (n= 11). Those subjects were considered not evaluable and not included in the denominator for the primary safety endpoint (total evaluable = 170 subjects).

Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis \> 50% as measured by Duplex Ultrasound (DUS). Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.

Time frame: 12 months post-index procedure

Population: ITT subjects. 25 subjects were excluded from the denominator due to discontinuation or other reasons prior to 12 month follow-up visit.

The Quality of Life (QoL) assessment of Chronic Venous Insufficiency Questionnaire (CIVIC-20) is a 20-item questionnaire which provides a global index and an outline of 4 QoL dimensions - pain (4 items), physical (4 items), psychological (9 items) and social (4 items). Items are scored on a scale from 1 to 5. A low score corresponds to greater patient comfort. Total CIVIQ-20 score is the sum of all 20-item scores The score of each dimension was obtained by adding up the scores of each constituent item within that dimension. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for evaluable ITT subjects. Lower values represent a better outcome, that is, a better QoL than that experienced at baseline.

Time frame: Evaluation at 12 months post-index procedure

Population: Evaluable ITT subjects were included in this analysis. (n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

The Venous Clinical Severity Score (VCSS) system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration. and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 means absent, 1 means mild, 2 means moderate and 3 means severe. Total VCSS is the sum of all VCSS assessment scores from categories for a given time point. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for Intent-to-Treat (ITT) subjects. Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline.

Time frame: Evaluation at 12 months post-index procedure

Population: Evaluable ITT subjects are included in this analysis.(n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification is a system that describes a doctor's physical exam findings for vein problem(s), the cause of the problem(s), the location in the leg, and the mechanism responsible for the manifestation of the vein problem. For Clinical classification, the clinical components indicates disease severity, ranging from none (0 points) to active ulcers (6 points).For each category of Etiology, Anatomy, and Pathophysiology classifications, at each time point, frequency of each category is reported. Subsequent clinical study reports will present CEAP at 24 and 36-months follow-up. Changes from baseline measures to given time points are presented. Lower mean scores represent an improvement from baseline measure.

Time frame: Evaluation through 30 day, 6 months and 12 months post index procedure

Population: Evaluable ITT subjects are included in this analysis. (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Technical success is defined as no major adverse events experienced between index procedure and discharge

Time frame: Less than 30 days post index procedure

Acute technical success is defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator.

Time frame: At time of Index Procedure

Freedom from Target Lesion Revascularization (TLR) through 30 days is specific to the first revascularization procedure of the target lesion.

Time frame: Evaluation throrugh 30 day, 6 months and 12 months post index procedure

Population: (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Freedom from Target Vessel Revascularization (TVR) is defined as the first revascularization procedure of the target vessel, as determined by an Independent Core Lab. Freedom from Target Lesion Revascularization (TLR) and Freedom from TVR results are the same through the 12 month analysis as all TLRs were also TVRs in this case.

Time frame: Evaluation through 30 days, 6 months and 12 months post index procedure

Population: (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Lesion Success is defined as the attainment of less or equal to 50% residual stenosis at the conclusion of the index procedure.

Time frame: At the conclusion of index procedure

Stents were evaluated at the 12 month follow-up for fracture analysis. Evaluable ITT subjects are included in this analysis.

Time frame: Evaluation at 12 months post-index procedure

Population: Evaluable ITT subjects are included in this analysis. (n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.