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Positioning Balloon Catheter
|Offroad Catheter – Short||Offroad Catheter – Long|
|Length||70 cm||79 cm||100 cm||109 cm|
|Maximum Length of Micro-Catheter Lancet Extension Beyond Positiomimg Balloon||2 cm||2 cm|
|Catheter Shaft OD||5 F (1.33 mm)||2.4 F (0.85 mm)||5 F (1.33 mm)||2.4 F (0.85 mm)|
|Nominal Balloon Diameter||5.4 mm||N/A||5.4 mm||N/A|
|Radiopaque Marker Position||Proximal Edge
of Balloon body
of Balloon body
|Nominal Inflation Pressure||2 ATM (203 kPA)||N/A||2 ATM (203 kPA)||N/A|
|Maximum Inflation Pressure||3.25 ATM (329 kPA)||N/A||3.25 ATM (329 kPA)||N/A|
|Sheath Diameter||6 F (1.33 mm)||N/A||6 F (1.33 mm)||N/A|
|Recommend Guidewire OD||0.035" (0.89 mm)||0.014" non-polymer coated||0.035" (0.89 mm)||0.014" non-polymer coated|
|M 001467120||180cm||0.014" (0.36 mm)|
|M 001467400||300 cm||0.014" (0.36 mm)|
To determine whether the OffRoad™ Re-entry Catheter System demonstrates acceptable performance in safety rates and device technical success for subintimal recanalization of a de novo or re-occluded chronic total occlusion (CTO) lesion in native femoropopliteal arteries
92-patient, prospective, single-arm, non-randomized, multi-center, post-market study conducted at 12 sites in Belgium, Germany and Switzerland.
|Mean length of Occlusion|
|Mean Reference Vessel Diameter|
|End Point||Definition||Performance Goal||All Patients (n=92)|
|Primary Safety||Composite rate of major adverse events (MAEs) related to 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)||MAE < 15%||MAE: 3.3%(3/87)|
|Primary Effectiveness||Device technical success defined as placement of a guidewire in the true lumen distal to a CTO as confirmed by the angiography core lab.||Technical success > 76%||Technical Success: 84.8%(78/92)|
|Additional Assessments||Average OffRoad System length of use time||N/A||11.1 minutes|
|Average total fluoroscopy time||N/A||21.0 minutes|
|Device-related perforation requiring intervention||N/A||0.00%|
The Re-ROUTE results demonstrated that the OffRoadᵀᴹ Re-entry Catheter System is a valid treatment option for recanalization of femoropopliteal CTOs