A Prospective, Multi-Center, Non-Randomized Study of the BD Bard COVERA™ PLUS Vascular Covered Stent in the Treatment of Iliac Artery Disease - Covera EU study

BD, Angiomed GmbH & Co. Medizintechnik KG0 sites101 target enrollmentNovember 6, 2019

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Treatment of stenoses and occlusions in common/external iliac arteries
Sponsor: BD, Angiomed GmbH & Co. Medizintechnik KG
Enrollment: 101
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

November 6, 2019

End Date

TBD

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

BD, Angiomed GmbH & Co. Medizintechnik KG

•Clinical Inclusion Criteria
•1\. The subject has been assessed Rutherford category 2, 3, 4 or 5 at the target limb(s).
•2\. The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) for the site.
•3\. Subject agrees to comply with the protocol\-mandated follow\-up procedures and visits.
•4\. The subject is a male or non\-pregnant female \= 18 years old with an expected lifespan sufficient to allow for completion of all study procedures.
•Angiographic Inclusion Criteria
•5\. The subject has evidence of a hemodynamically relevant stenosis or restenosis \=50% (as determined by the Investigator’s visual estimate) or occlusion in the native common or external iliac artery, and the vessel diameter is appropriate for treatment with available stent sizes (refer to IFU).
•6\. The target lesion is \= 100 mm in total length by visual estimate. The target lesion may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion.

•Clinical Exclusion Criteria
•1\. The subject is unable or unwilling to provide written informed consent, or is unable or unwilling to conform to the study protocol follow\-up procedures and visits.
•2\. The subject has a known allergy or sensitivity to nitinol (Nickel, Titanium), tantalum, or contrast media which cannot be adequately pre\-medicated.
•3\. The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non\-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow\-up.
•Angiographic Exclusion Criteria
•4\. The target lesion prevents full expansion of an appropriately sized PTA balloon (pre\-dilatation of the target lesion is required).
•5\. The target lesion has been previously treated with a stent. A target vessel with a previously placed stent is permitted as long as the subject device will not come into contact with the previously placed stent during treatment of the target lesion.
•6\. The subject has a clinically relevant abdominal aortic aneurysm (AAA) or aneurysm within or contiguous to the target lesion.