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

• Conditions: Treatment of stenoses and occlusions in common/external iliac arteries; I73.9; Peripheral vascular disease, unspecified

• Registration Number: DRKS00017906
• Lead Sponsor: BD, Angiomed GmbH & Co. Medizintechnik KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is defined as Target Lesion Revascularization (TLR) through 9-months post-index procedure. TLR is defined as the first revascularization (endovascular or surgery) of the target lesion following the index procedure.