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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01500031
First received: December 19, 2011
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Total Occlusion
 Device: OffRoad Re-entry Catheter System
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Composite rate of major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Device technical success: placement of a guidewire in the true lumen distal to a CTO [ Time Frame: Device technical success is determined during the index procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 95
Study Start Date: April 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OffRoad Re-entry Catheter System
    Facilitate the placement and positioning of guidewires within the peripheral vasculature.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Claudication or critical limb ischemia (Rutherford Category 2-5)
  • Documented de novo or re-occluded 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500031

Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Andrej Schmidt Herzzentrum Leipzig GmbH/ Park Krankenhaus Leipzig GmbH
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01500031     History of Changes
Other Study ID Numbers: S2273
Study First Received: December 19, 2011
Last Updated: May 30, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

ClinicalTrials.gov processed this record on May 21, 2013