Phase 4 N=92 Treatment

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

Chronic Total Occlusion

Bottom Line

View on ClinicalTrials.gov: NCT01500031 ↗

Enrolled (actual)

Serious AEs

22.8%

Results posted

Apr 2014

Primary outcome: Primary: Composite Rate of Major Adverse Events — 3.3 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: OffRoad Re-entry Catheter System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite Rate of Major Adverse Events	3.3	—
PRIMARY Effectiveness (On the Day of Procedure)	84.8	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01500031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.