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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Total Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OffRoad Re-entry catheter

Participants treated with OffRoad Re-entry Catheter System

Group Type EXPERIMENTAL

OffRoad Re-entry Catheter System

Intervention Type DEVICE

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

Interventions

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OffRoad Re-entry Catheter System

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No