Crosser Enters The Right Arterial Lumen (CENTRAL)

The purpose of this study is to determine if the CROSSER CTO Recanalization System can facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100% narrowing of the artery, with no angiographically detectable antegrade blood flow, and the assessment that the lesion has been in existence for a minimum of 30 days. This study will enroll up to 100 patients at up to 8 clinical sites. The CROSSER CTO Recanalization System was cleared for commercialization by the US Food & Drug Administration. This study also involves an imaging device called the IVUS (Intravascular Ultrasound Imaging) catheter. This device has been cleared for commercialization by the US Food and Drug Administration and will be studied for its cleared intended use. The IVUS catheter is used to generate real-time images of the artery, which will allow for evaluation of the artery after the occlusion is crossed. This is a post-market registry.

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion of Artery of the Extremities
• Intervention / Treatment: Device: 1. CROSSER System

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Iowa
    • Des Moines, Iowa, United States, 50325
      • Iowa Methodist Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital and Medical Center
    • Wyoming, Michigan, United States, 49519
      • Metro Health Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Heart and Vascular Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45243
      • The Christ Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Memphis Heart Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with CTO who are indicated for recanalization.

Description

Inclusion Criteria:

• Patient must have objective evidence of lower extremity ischemia and scheduled to undergo an endovascular recanalization.
• Occluded artery must be the native superficial femoral artery.
• Patient must have a totally occlusive lesion classified angiographically as absolute (100% occlusion with no flow).
• Patient's target vessel occlusion length is ≤ 30 cm.
• Patient's reference vessel diameter is greater than or equal to 3.0mm.
• Patient must be an acceptable candidate for PTA, peripheral artery bypass surgery or peripheral artery stent implantation.
• Female patients of child bearing potential must have a negative pregnancy test within 72 hours prior to the study procedure.
• Patient or guardian must have been informed of the nature of the study, agree to its provisions, and provide written informed consent.
• Patient is ≥ 18 years of age.

Exclusion Criteria:

• Patient has hypersensitivity or contraindication to aspirin, heparin or radiographic contrast agents which cannot be adequately pre-medicated.
• The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels.
• Patient's occlusion is a flush occlusion initiating less than 2cm from the ostium.
• Patient has planned infrainguinal intervention scheduled within 30 days after index procedure.
• The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period.
• Patient has no collateral flow distal to the occlusion.
• Patient's target occlusion has a dissection that occurred within the past 60 days caused by a guidewire attempt.
• Patient has a history of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency.
• Patient suffered recent (within the past 6 months) stroke or transient ischemic neurological attack (TIA).
• Patient suffered recent (within the past 6 months) significant gastrointestinal (GI) bleeding.
• Patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CROSSER	Device: 1. CROSSER System; The Crosser system will be used to recanalize the chronic total occlusion in the SFA (superficial femoral artery). The IVUS (Intravascular Ultrasound Imaging) System will be used in the treated occlusion after the Crosser to generate real-time images of the artery.; Other Names: Crosser catheter; IVUS catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crosser navigates through the central lumen of the artery	Successful navigation of the CROSSER CTO Recanalization Catheter in the central lumen of the artery as confirmed by Intravascular Ultrasound (IVUS) following recanalization	At time of procedure (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success - crossing the CTO into the true distal lumen	The ability to facilitate crossing the CTO into the true distal lumen with the CROSSER Catheter and/or any conventional guidewire after use of the CROSSER.	At time of procedure (Day 0)
Procedural Success - Technical success plus residual stenosis < 50% and improved flow	Achievement of Technical Success plus a residual stenosis <50%, and improved flow verified angiographically, at the conclusion of the procedure.	Time of Procedure (Day 0)
Clinical Success - freedom from limb loss and repeat revascularization	Clinical Success - freedom from limb loss, and repeat revascularization (bypass surgery, or PTA) from index hospitalization through 6 moth follow-up	6 month follow-up

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Thomas P. Davis, MD, St. John Hospital & Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: September 17, 2010
• First Posted (Estimate): September 20, 2010

Study Record Updates

• Last Update Posted (Estimate): September 10, 2013
• Last Update Submitted That Met QC Criteria: September 6, 2013
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: SFA; CTO; PAOD; peripheral artery occlusive disease; superficial femoral artery
• Other Study ID Numbers: CR1055-01