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

NCT01500031 | Completed Phase 4 Results DMC

• 1 other identifier: S2273
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Total Occlusion

Outcome Measures

Primary Outcomes (2)

• Composite Rate of Major Adverse Events

  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.

  30 days

• Effectiveness (On the Day of Procedure)

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

  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

Other Outcomes (10)

• Device-related Death

  30 days

• Device-related Perforation Requiring Intervention

  30 days

• Device-related Clinically Significant Peripheral Embolism

  30 days

Study Arms (1)

OffRoad Re-entry catheter

EXPERIMENTAL

Participants treated with OffRoad Re-entry Catheter System

Device: OffRoad Re-entry Catheter System

Interventions

OffRoad Re-entry Catheter System DEVICE

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

OffRoad Re-entry catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Related Publications (1)

• Schmidt A, Keirse K, Blessing E, Langhoff R, Diaz-Cartelle J; European Study Group. Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries: primary safety and effectiveness results of the re-route trial. J Cardiovasc Surg (Torino). 2014 Aug;55(4):551-8. Epub 2014 Jun 13.

  PMID: 24926886 DERIVED

Results Point of Contact

• Title: Director Clinical Trials
• Organization: Boston Scientific

Pamela.Grady@bsci.com

708-771-4737

Study Officials

• Andrej Schmidt

  Herzzentrum Leipzig GmbH/ Park Krankenhaus Leipzig GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 26, 2011
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 15, 2014
• Results First Posted: April 15, 2014

Record last verified: 2014-03