Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).
Conditions
Brief summary
To evaluate the procedural safety and filter efficiency of the FiberNet® Embolic Protection System when used in conjunction with the Boston Scientific Express SD Stent System for primary stenting of ostial atherosclerotic renal lesions in patients with atherosclerotic renal artery stenosis.
Interventions
DEVICELumen Biomedical FiberNet Embolic Protection System
to demonstrate the safety and filter efficiency of the Lumen Biomedical FiberNet Embolic Protection System during the performance of primary renal stenting in the treatment of pts with a high grade ostial atherosclerotic renal lesion(s).
Sponsors
Lumen Biomedical
Prairie Education and Research Cooperative
VIVA Physicians
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 85 years. 2. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed an IRB approved consent form. 3. Subject understands the duration of the study and it's follow up visit requirements. 4. Unilateral or bilateral atherosclerotic de novo renal artery stenosis (RAS) associated with any or all of the following: 1. SBP \>140 despite ≥3 anti-hypertensive medications 2. Estimated Glomerular Filtration Rate (eGFR) ≥30-≤70 cc/min calculated using the Modified Diet in Renal Disease (MDRD) formula 3. Recurrent episodes of decompensated heart failure 4. Recurrent episodes of flash pulmonary edema Angiographic Inclusion Criteria 1. ≥70% \<100% renal artery stenosis (by visual estimate) involving unilateral, bilateral renal arteries or solitary renal artery. 2. Renal pole-to-pole length \>7cm. 3. Lesion ≤15 mm from the aorto-ostial junction. 4. Renal artery reference lumen diameter ≥3.5 - ≤7 mm for FiberNet placement.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurable amount of macro/micro atheroma particle captured by the FiberNet EPS as adjudicated by core lab analysis. | Various secondary endpoints evaluated at 30 days and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression to temporary/permanent renal replacement therapy and Analysis of debris captured by the FiberNet® Embolic Protection System | most at 30 days and 6 months |
Countries
United States
Outcome results
None listed