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Embolic Protection System

FiberNet Distal Protection System for Renal Stenting (FORTRESS Trial)

Q: Is it possible to sign up for this research experiment at present?

Reports hosted on clinicaltrials.gov indicate that this particualr medical trial is not recruiting at the current time, with its first posting being January 1st 2008 and last update occuring February 16th 2010. However, there are still other trials actively searching for candidates to participate in their studies.

Q: Is there an opportunity for me to join this experiment?

The requirements to join this clinical trial include a successful renal stenting procedure and an age range between 18-85. At present, approximately 20 individuals are being sought for the trial.

Q: Are those in the 40-and-above age group being enlisted for this experiment?

This research project is open to participants aged 18 and above, up until their 85th year.

N/A

Waitlist Available

Research Sponsored by VIVA Physicians

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 and ≤ 85 years

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up most at 30 days and 6 months

Awards & highlights

FORTRESS Trial Summary

This trial was to test the safety and efficiency of a new type of stent for people with atherosclerotic renal artery stenosis.

Who is the study for?

Adults aged 18-85 with specific kidney artery narrowing (70%-100% stenosis) who suffer from high blood pressure despite taking multiple medications, and have had episodes of heart failure or 'flash' pulmonary edema. They must have a certain level of kidney function (eGFR ≥30-≤70), and understand the study's requirements. Excluded are those with life expectancy <12 months, severe other diseases, allergies to necessary drugs or materials used in the trial, recent or upcoming surgeries outside the study scope, pregnant women, and others deemed unsuitable by investigators.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of Lumen Biomedical's FiberNet Embolic Protection System when used alongside Boston Scientific Express SD Stent for treating narrowed arteries in kidneys due to plaque buildup in patients with renal artery stenosis.See study design

What are the potential side effects?

Potential side effects may include reactions related to device placement such as bleeding at the access site, damage to kidney vessels, allergic reactions to materials or medication used during procedure. The specifics will be monitored closely throughout the trial.

FORTRESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

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I have narrowed arteries to my kidneys, high blood pressure despite medication, kidney function issues, or sudden heart or lung problems.

Select...

My kidney artery is narrowed by 70-100%, and my kidney is longer than 7cm. The blockage is close to where the artery starts, and the artery is 3.5-7 mm wide.

FORTRESS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ most at 30 days and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~most at 30 days and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and most at 30 days and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Progression to temporary/permanent renal replacement therapy and Analysis of debris captured by the FiberNet® Embolic Protection System

FORTRESS Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment, Open label, Single Group AssignmentExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VIVA PhysiciansLead Sponsor

4 Previous Clinical Trials

289 Total Patients Enrolled

Lumen BiomedicalIndustry Sponsor

5 Previous Clinical Trials

346 Total Patients Enrolled

Prairie Education and Research CooperativeIndustry Sponsor

5 Previous Clinical Trials

1,857 Total Patients Enrolled

Media Library

Lumen Biomedical FiberNet Embolic Protection System (Embolic Protection System) Clinical Trial Eligibility Overview. Trial Name: NCT00674505 — N/A

Renal Stenting Research Study Groups: Treatment, Open label, Single Group Assignment

Renal Stenting Clinical Trial 2023: Lumen Biomedical FiberNet Embolic Protection System Highlights & Side Effects. Trial Name: NCT00674505 — N/A

Lumen Biomedical FiberNet Embolic Protection System (Embolic Protection System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00674505 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to sign up for this research experiment at present?

"Reports hosted on clinicaltrials.gov indicate that this particualr medical trial is not recruiting at the current time, with its first posting being January 1st 2008 and last update occuring February 16th 2010. However, there are still other trials actively searching for candidates to participate in their studies."

Answered by AI

Is there an opportunity for me to join this experiment?

"The requirements to join this clinical trial include a successful renal stenting procedure and an age range between 18-85. At present, approximately 20 individuals are being sought for the trial."

Answered by AI