Treatment of stenoses and occlusions in common/external iliac arteries I73.9
Conditions
Interventions
Group 1: This is a prospective, multi-center, non-randomized clinical study of the COVERA™ PLUS Vascular Covered Stent for the treatment of stenoses and occlusions in the common/external iliac arterie
Sponsors
BD, Angiomed GmbH & Co. Medizintechnik KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| – Safety is defined as freedom from device- and/or procedure-related death or myocardial infarction (MI), or any TLR, or target limb major amputation (above the ankle) through 30 days. TLR is defined as the first revascularization (endovascular or surgery) of the target lesion following the index procedure. - Acute Technical Success defined as successful deployment of the study device implant at the intended location, as determined by the Investigator. - Acute Lesion Success defined as attainment of 2.4 (>50% stenosis), as determined by an Independent DUS Core Lab. - Secondary Patency at 9, 24, 36 and 60 months post-index procedure (freedom from repeated TLR and/or restenosis). - Quality of Life as assessed by a Walking Impairment Questionnaire (WIQ) at baseline, 30 days, 9, 24, 36, 48 and 60 months post-index procedure. | — |
Countries
Germany
Contacts
Public ContactJens Ripcke
BD, Angiomed GmbH & Co. Medizintechnik KG
Outcome results
None listed