Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries (Re-ROUTE)

Boston Scientific

Status and phase: Completed; Phase 4

Conditions: Chronic Total Occlusion

Treatments: Device: OffRoad Re-entry Catheter System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01500031

S2273

Details and patient eligibility

About

Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Claudication or critical limb ischemia (Rutherford Category 2-5)
• Documented de novo or re-occluded Chronic Total Occlusion (CTO) (99-100% stenosed) lesion in native femoropopliteal artery
• Target vessel occlusion length is ≥ 1 cm and ≤ 30 cm
• Minimum reference vessel diameter is 4 mm

Exclusion criteria

• Contraindication to an endovascular procedure
• Previous stent placement in the target vessel
• Prior surgery of the superficial femoral artery (SFA) in the target limb to treat atherosclerotic disease
• Platelet count <150,000 mm3 or >600,000 mm3
• Renal insufficiency with a serum creatinine >2.3 mg/dl
• History of major amputation (ankle level or above) in the same limb as the target lesion
• Current participation in another drug or device clinical study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

OffRoad Re-entry catheter

Experimental group

Description:

Participants treated with OffRoad Re-entry Catheter System

Treatment:

Device: OffRoad Re-entry Catheter System