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

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

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion
• Intervention / Treatment: Device: OffRoad Re-entry Catheter System

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OffRoad Re-entry catheter; Participants treated with OffRoad Re-entry Catheter System	Device: OffRoad Re-entry Catheter System; Facilitate the placement and positioning of guidewires within the peripheral vasculature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Rate of Major Adverse Events	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.	30 days
Effectiveness (On the Day of Procedure)	Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related Death	All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.	30 days
Device-related Perforation Requiring Intervention	All perforation requiring intervention related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.	30 days
Device-related Clinically Significant Peripheral Embolism	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.	30 days
Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb	All Major amputations related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.	30 days
All Adverse Events	All adverse events (AEs) reported by the centers.	30 days
Acute Procedure Success	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)}	30 days
Target Lesion Revascularization Due to a Complication	Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.	30 days
Device-related Dissection, Grade C or Greater	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.	30 days
Overall Procedure Time	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.	On the day of Procedure
OffRoad System Use Length of Time	From time of "positioning balloon catheter" introduced in the body until time "final OffRoad component" removed.	On the day of Procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Andrej Schmidt, Herzzentrum Leipzig GmbH/ Park Krankenhaus Leipzig GmbH

Publications and helpful links

General Publications

• Schmidt A, Keirse K, Blessing E, Langhoff R, Diaz-Cartelle J; European Study Group. Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries: primary safety and effectiveness results of the re-route trial. J Cardiovasc Surg (Torino). 2014 Aug;55(4):551-8. Epub 2014 Jun 13.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: December 23, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: March 10, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: S2273