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

Boston Scientific Corporation92 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Total Occlusion

Interventions

OffRoad Re-entry Catheter SystemDEVICE

Facilitate the placement and positioning of guidewires within the peripheral vasculature.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

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