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

Chronic Total Occlusion Clinical Trial

— Re-ROUTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500031
• Other study ID #: S2273
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2011
• Last updated: March 10, 2014
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Total Occlusion

Intervention

Device:
• OffRoad Re-entry Catheter System
Facilitate the placement and positioning of guidewires within the peripheral vasculature.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	All Adverse Events	All adverse events (AEs) reported by the centers.	30 days	Yes
Other	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	No
Other	Target Lesion Revascularization Due to a Complication	Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.	30 days	Yes
Other	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	Yes
Other	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	No
Other	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	No
Primary	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	Yes
Primary	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	No