Peripheral artery disease
Conditions
Interventions
Group 1: E-Luminexx™ Vascular Stent
Sponsors
Angiomed GmbH & Co. Medizintechnik KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The E-Luminexx™/LifeStar™ Vascular Stent was implanted for the purpose of treatment of atherosclerotic lesions in the common and / or external iliac arteries. 2. The subject had been assessed Rutherford Category 2, 3, 4 or 5 at the target limb(s) prior to stent implantation at the baseline examination. 3. The E-Luminexx™/LifeStar™ Vascular Stent was placed between January 2013 and June 2018 and key clinical data are available for at least 36 months follow-up. Key clinical data are defined as: a. Existing data on standard of care visits at 12 months and at 36 months post index procedure. Each 12 months and 36 months visit must include a target limb examination with resting ankle-brachial Index (ABI) or toe-brachial index (TBI), assessment of Rutherford Category and assessment of patency based on freedom from clinical symptoms or based on imaging (DUS, CTA, MRA, DSA or angiogram). b. Information on any performed interventions at the target lesion is available throughout 36 months post index procedure. c. Information on any MAEs through 30 days post index procedure is documented in the subject’s medical record. d. Criteria a), b) and c) do not apply to subjects who deceased during implantation or prior to 36 months follow-up. 4. The subject was = 18 years old at the time of implantation of the E-Luminexx™ / LifeStar™ Vascular Stent. 5. Provision of signed and dated informed consent form. If the subject is deceased, data are acquired in an anonymous format. Angiographic Inclusion Criteria: 6. The subject had 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 was appropriate for treatment with available stent sizes (refer to Instructions for Use (IFU)). 7. 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: Angiographic Exclusion Criteria 1. Prior to implantation of the E-Luminexx™/LifeStar™ Vascular Stent, the target lesion has previously been treated with a stent. 2. Absence of a target lesion (i.e. diseased or damaged artery) in the area covered by the E-Luminexx™/LifeStar™ Vascular Stent. 3. The subject had a clinically relevant abdominal aortic aneurysm (AAA) or aneurysm within or contiguous to the target lesion prior to implantation of the E-Luminexx™/LifeStar™ Vascular Stent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with freedom from target lesion revascularization (ffTLR) at 36 months post index procedure. Target lesion revascularization (TLR) is defined as any revascularization (endovascular or surgery) of the target lesion following the index procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Percentage of subjects with ffTLR at 12 months and at 60 months post index procedure • Improvement in Rutherford Category = 1 at 12, 36, and 60 months post index procedure • Percentage of subjects with a major adverse events (MAEs) (defined as procedure-related death, stroke, target lesion re-intervention, major amputation above the ankle at target limb) through 30 days post index procedure (safety endpoint) • Device success defined as successful stent deployment at the target lesion • Technical success (<30% residual stenosis) • Primary patency rate at 12, 36, and 60 months post index procedure. Primary patency is defined as absence of hemodynamically significant restenosis at the target area as assessed by freedom from clinical symptoms or based on imaging (=50% restenosis or systolic velocity ratio = 2.5) and without prior TLR. Imaging can be based on duplex ultrasound (DUS), computed tomography angiography (CTA), magnetic resonance angiography (MRA), digital subtraction angiography (DSA) or angiogram. | — |
Countries
Germany
Contacts
Public ContactChristine Espinola-Klein
Universitätsmedizin der Johannes Gutenberg-Universität Mainz- Zentrum für Kardiologie
Outcome results
None listed