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Trial record 1 of 4 for:    Re-ROUTE
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Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries (Re-ROUTE)

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ClinicalTrials.gov Identifier: NCT01500031
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Chronic Total Occlusion Device: OffRoad Re-entry Catheter System Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Composite Rate of Major Adverse Events [ Time Frame: 30 days ]

    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.


  2. 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 ]
    Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)


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

  2. Device-related Perforation Requiring Intervention [ Time Frame: 30 days ]

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

    Events are based on site reported Adverse Event data.


  3. Device-related Clinically Significant Peripheral Embolism [ Time Frame: 30 days ]

    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.


  4. Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb [ Time Frame: 30 days ]

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

    Events are based on site reported Adverse Event data.


  5. All Adverse Events [ Time Frame: 30 days ]
    All adverse events (AEs) reported by the centers.

  6. Acute Procedure Success [ Time Frame: 30 days ]
    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)}

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

  8. Device-related Dissection, Grade C or Greater [ Time Frame: 30 days ]

    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.


  9. Overall Procedure Time [ Time Frame: On the day of Procedure ]
    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.

  10. OffRoad System Use Length of Time [ Time Frame: On the day of Procedure ]
    From time of "positioning balloon catheter" introduced in the body until time "final OffRoad component" removed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500031


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01500031    
Other Study ID Numbers: S2273
First Posted: December 26, 2011    Key Record Dates
Results First Posted: April 15, 2014
Last Update Posted: April 15, 2014
Last Verified: March 2014