Status:
COMPLETED
Crosser Enters The Right Arterial Lumen
Lead Sponsor:
C. R. Bard
Conditions:
Chronic Total Occlusion of Artery of the Extremities
Eligibility:
All Genders
18+ years
Brief Summary
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 Ar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01205386
Start Date
February 1 2010
End Date
August 1 2012
Last Update
September 10 2013
Active Locations (8)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50325
3
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
4
Metro Health Hospital
Wyoming, Michigan, United States, 49519