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Completed

NCT Number: NCT01500031

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

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

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Key information

Conditions

Chronic Total Occlusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OffRoad Re-entry Catheter System

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: Re-ROUTE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 26, 2011
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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