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

Phase 4

Completed

• Conditions: Chronic Total Occlusion
• Interventions: Device: OffRoad Re-entry Catheter System

• Registration Number: NCT01500031
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-23
• Study First Posted: 2011-12-26
• Study Start: 2012-04
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Results First Submitted: 2014-01-06
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-10
• Last Update Submitted: 2014-03-10
• Results First Posted: 2014-04-15
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OffRoad Re-entry catheter	OffRoad Re-entry Catheter System	Participants treated with OffRoad Re-entry Catheter System

Primary Outcome Measures

Name	Time	Method
Composite Rate of Major Adverse Events	30 days	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.
Effectiveness (On the Day of Procedure)	Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body	Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)