NCT00674505

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

1.4 years

First QC Date

May 6, 2008

Last Update Submit

February 16, 2010

Conditions

Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Treatment, Open label, Single Group Assignment

OTHER
Device: Lumen Biomedical FiberNet Embolic Protection System

Interventions

Lumen Biomedical FiberNet Embolic Protection SystemDEVICE

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).

Treatment, Open label, Single Group Assignment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • ≥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.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIVA Physicians Inc.

San Jose, California, 95123, United States

Location

Related Publications (1)

  • Laird JR, Tehrani F, Soukas P, Joye JD, Ansel GM, Rocha-Singh K. Feasibility of FiberNet(R) embolic protection system in patients undergoing angioplasty for atherosclerotic renal artery stenosis. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):430-6. doi: 10.1002/ccd.23292. Epub 2011 Dec 8.

    PMID: 21805607DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 8, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2009

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations

US(1)