Clinical trial NCT01500031: Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries
Official title: Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Total Occlusion
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Composite Rate of Major Adverse Events
timeFrame: 30 days
measure: Effectiveness (On the Day of Procedure)
timeFrame: 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
Secondary outcomes:
Other outcomes:
measure: Device-related Death
timeFrame: 30 days
measure: Device-related Perforation Requiring Intervention
timeFrame: 30 days
measure: Device-related Clinically Significant Peripheral Embolism
timeFrame: 30 days
measure: Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb
timeFrame: 30 days
measure: All Adverse Events
timeFrame: 30 days
measure: Acute Procedure Success
timeFrame: 30 days
measure: Target Lesion Revascularization Due to a Complication
timeFrame: 30 days
measure: Device-related Dissection, Grade C or Greater
timeFrame: 30 days
measure: Overall Procedure Time
timeFrame: On the day of Procedure
measure: OffRoad System Use Length of Time
timeFrame: On the day of Procedure
Locations:
Study officials:
affiliation: Herzzentrum Leipzig GmbH/ Park Krankenhaus Leipzig GmbH
name: Andrej Schmidt
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.