Safety & Performance Study of Lumen Biomedical's FiberNet Distal Protection System for the Treatment of Renal Artery Stenosis
This trial is active, not recruiting.
|Condition||renal stenting in the treatment of pts w/a high grade ostial atherosclerotic renal lesion(s).|
|Treatment||lumen biomedical fibernet embolic protection system|
|Start date||January 2008|
|End date||June 2009|
|Trial size||20 participants|
|Trial identifier||NCT00674505, G070189/S002|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Measurable amount of macro/micro atheroma particle captured by the FiberNet EPS as adjudicated by core lab analysis.
time frame: Various secondary endpoints evaluated at 30 days and 6 months
Progression to temporary/permanent renal replacement therapy and Analysis of debris captured by the FiberNet® Embolic Protection System
time frame: most at 30 days and 6 months
Male or female participants from 18 years up to 85 years old.
- Age ≥ 18 and ≤ 85 years.
- 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.
- Subject understands the duration of the study and it's follow up visit requirements.
- Unilateral or bilateral atherosclerotic de novo renal artery stenosis (RAS) associated with any or all of the following:
- SBP >140 despite ≥3 anti-hypertensive medications
- Estimated Glomerular Filtration Rate (eGFR) ≥30-≤70 cc/min calculated using the Modified Diet in Renal Disease (MDRD) formula
- Recurrent episodes of decompensated heart failure
- Recurrent episodes of "flash" pulmonary edema Angiographic Inclusion Criteria
- ≥70% <100% renal artery stenosis (by visual estimate) involving unilateral, bilateral renal arteries or solitary renal artery.
- Renal pole-to-pole length >7cm.
- Lesion ≤15 mm from the aorto-ostial junction.
- Renal artery reference lumen diameter ≥3.5 - ≤7 mm for FiberNet placement.
- Estimated life expectancy <12 months.
- Estimated Glomerular Filtration Rate (eGFR) <30 cc/min.
- Renal pole-to-pole length <7cm on side of diseased kidney.
- No history of transplanted kidneys or polycystic kidney disease.
- Uncontrolled hypercoagulability.
- Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies, nitinol and stainless steel.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Patient refuses possible temporary or permanent hemodialysis.
- Refuses possible surgery for repair of access site or renal artery.
- Known severe coronary or carotid disease likely to require surgical treatment after enrollment or during follow-up period.
- Uncompensated congestive heart failure.
- Current enrollment in any investigational study wherein patient participation has not been completed.
- Cardiovascular surgical or cardiovascular interventional procedures (including, but not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to enrollment in this study.
- Planned or predicted cardiovascular surgical or interventional procedures outside of the affected renal artery (including, but not limited to, aortic, renal, cardiac, carotid, contralateral femoro-popliteal, and contralateral below the knee) within 30 days after entry into this study and prior to completion of the 30 day follow-up.
- Pregnancy, breast-feeding or plans to become pregnant in female of child bearing potential.
- Any patient who in the opinion of the investigator would not be a good candidate for enrollment. Angiographic Exclusion Criteria
- Early bifurcation of the main renal artery preventing complete embolic protection of the kidney with the FiberNet.
- Fibromuscular Dysplasia.
- Presence of thrombus at the lesion site.
- Non-ostial atherosclerosis (lesion >15mm from the renal ostium).
- Subintimal guidewire placement resulting in dissection of the renal artery or aorta, or perforation of the renal artery or aorta prior to deployment of the device.
- Severe calcification likely to prevent the passage of the device. -
|Official title||FiberNet Renal Artery Embolic Protection Study: A Prospective, Single-arm Feasibility Trial of Renal Artery Distal Protection Using the Lumen Biomedical FiberNet Embolic Protection System|
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