Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above).

Events are based on data adjudicated by a Clinical Event Committee.

The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day)

Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)

The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis.

All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).

All perforation requiring intervention related to the use of the OffRoad Re-entry Catheter System.

Events are based on site reported Adverse Event data.

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).

All clinically significant peripheral embolisms related to the use of the OffRoad Re-entry Catheter System.

Events are based on site reported Adverse Event data.

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).

All Major amputations related to the use of the OffRoad Re-entry Catheter System.

Events are based on site reported Adverse Event data.

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).

All adverse events (AEs) reported by the centers.

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).

Acute Procedure Success, defined as device technical success and the absence of in-hospital Major Adverse Events {death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above)}

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).

Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).

Type A- Small radiolucent area within the lumen of the vessel disappearing with the passage of the contrast material.

Type B- Appearance of contrast medium parallel to the lumen of the vessel disappearing within a few cardiac cycles.

Type C- Dissection protruding outside the lumen of the vessel persisting after passage of the contrast material.

Type D- Spiral shaped filling defect with or without delayed run-off of the contrast material in the antegrade flow.

Type E- Persistent luminal filling defect with delayed run-off of the contrast material in the distal lumen.

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).

Defined as the time when the treating physician first punctures the skin in order to obtain access to the artery to treat the target lesion until the time the introducer sheath is removed from the body.

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis.

From time of "positioning balloon catheter" introduced in the body until time "final OffRoad component" removed.

All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 1 participant was not evaluable (No data available).