UnknownNot Applicable

Safety & Performance Study of Lumen Biomedical's FiberNet Distal Protection System for the Treatment of Renal Artery Stenosis

United States20 participantsStarted 2008-01

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measurable amount of macro/micro atheroma particle captured by the FiberNet EPS as adjudicated by core lab analysis.

Timeframe: Various secondary endpoints evaluated at 30 days and 6 months

Trial details

NCT IDNCT00674505

SponsorVIVA Physicians

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-06

View on ClinicalTrials.gov More Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s). trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Safety & Performance Study of Lumen Biomedical's FiberNet Distal Protection System for the Treatment of Renal Artery Stenosis

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Safety & Performance Study of Lumen Biomedical's FiberNet Distal Protection System for the Treatment of Renal Artery Stenosis

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria