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Crosser Enters The Right Arterial Lumen (CENTRAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01205386
First received: April 26, 2010
Last updated: September 6, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention
Chronic Total Occlusion of Artery of the Extremities
Device: 1. CROSSER System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Crosser Enters The Right Arterial Lumen

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Crosser navigates through the central lumen of the artery [ Time Frame: At time of procedure (day 0) ] [ Designated as safety issue: No ]
    Successful navigation of the CROSSER CTO Recanalization Catheter in the central lumen of the artery as confirmed by Intravascular Ultrasound (IVUS) following recanalization


Secondary Outcome Measures:
  • Technical Success - crossing the CTO into the true distal lumen [ Time Frame: At time of procedure (Day 0) ] [ Designated as safety issue: No ]
    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.

  • Procedural Success - Technical success plus residual stenosis < 50% and improved flow [ Time Frame: Time of Procedure (Day 0) ] [ Designated as safety issue: No ]
    Achievement of Technical Success plus a residual stenosis <50%, and improved flow verified angiographically, at the conclusion of the procedure.

  • Clinical Success - freedom from limb loss and repeat revascularization [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    Clinical Success - freedom from limb loss, and repeat revascularization (bypass surgery, or PTA) from index hospitalization through 6 moth follow-up


Enrollment: 100
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with CTO who are indicated for recanalization.

Criteria

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.
  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: NCT01205386

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Iowa
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50325
United States, Michigan
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
Mercy Heart and Vascular Center
Coon Rapids, Minnesota, United States, 55433
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45243
United States, Tennessee
Memphis Heart Clinic
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Thomas P. Davis, MD St. John Hospital and Medical Center
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01205386     History of Changes
Other Study ID Numbers: CR1055-01
Study First Received: April 26, 2010
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by C. R. Bard:
CTO
peripheral artery occlusive disease
PAOD
SFA
superficial femoral artery

ClinicalTrials.gov processed this record on November 24, 2014