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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01500031
First received: December 19, 2011
Last updated: March 10, 2014
Last verified: March 2014
  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 ]

    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.


  • Effectiveness (On the Day of Procedure) [ 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 ] [ Designated as safety issue: No ]
    Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)


Other Outcome Measures:
  • Device-related Death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.

  • Device-related Perforation Requiring Intervention [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    All perforation requiring intervention related to the use of the OffRoad Re-entry Catheter System.

    Events are based on site reported Adverse Event data.


  • Device-related Clinically Significant Peripheral Embolism [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    All clinically significant peripheral embolisms related to the use of the OffRoad Re-entry Catheter System.

    Events are based on site reported Adverse Event data.


  • Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    All Major amputations related to the use of the OffRoad Re-entry Catheter System.

    Events are based on site reported Adverse Event data.


  • All Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    All adverse events (AEs) reported by the centers.

  • Acute Procedure Success [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Acute Procedure Success, defined as device technical success and the absence of in-hospital Major Adverse Events {death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above)}

  • Target Lesion Revascularization Due to a Complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.

  • Device-related Dissection, Grade C or Greater [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    Type A- Small radiolucent area within the lumen of the vessel disappearing with the passage of the contrast material.

    Type B- Appearance of contrast medium parallel to the lumen of the vessel disappearing within a few cardiac cycles.

    Type C- Dissection protruding outside the lumen of the vessel persisting after passage of the contrast material.

    Type D- Spiral shaped filling defect with or without delayed run-off of the contrast material in the antegrade flow.

    Type E- Persistent luminal filling defect with delayed run-off of the contrast material in the distal lumen.


  • Overall Procedure Time [ Time Frame: On the day of Procedure ] [ Designated as safety issue: No ]
    Defined as the time when the treating physician first punctures the skin in order to obtain access to the artery to treat the target lesion until the time the introducer sheath is removed from the body.

  • OffRoad System Use Length of Time [ Time Frame: On the day of Procedure ] [ Designated as safety issue: No ]
    From time of "positioning balloon catheter" introduced in the body until time "final OffRoad component" removed.


Enrollment: 92
Study Start Date: April 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OffRoad Re-entry catheter
Participants treated with OffRoad Re-entry Catheter System
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: January 6, 2014
Last Updated: March 10, 2014
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 November 25, 2014