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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by VIVA Physicians.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Lumen Biomedical
Prairie Education and Research Cooperative
Information provided by:
VIVA Physicians
ClinicalTrials.gov Identifier:
NCT00674505
First received: May 6, 2008
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).
Device: Lumen Biomedical FiberNet Embolic Protection System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Further study details as provided by VIVA Physicians:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2008
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment, Open label, Single Group Assignment Device: Lumen 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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Exclusion Criteria

  1. Estimated life expectancy <12 months.
  2. Estimated Glomerular Filtration Rate (eGFR) <30 cc/min.
  3. Renal pole-to-pole length <7cm on side of diseased kidney.
  4. No history of transplanted kidneys or polycystic kidney disease.
  5. Uncontrolled hypercoagulability.
  6. Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies, nitinol and stainless steel.
  7. Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
  8. Patient refuses possible temporary or permanent hemodialysis.
  9. Refuses possible surgery for repair of access site or renal artery.
  10. Known severe coronary or carotid disease likely to require surgical treatment after enrollment or during follow-up period.
  11. Uncompensated congestive heart failure.
  12. Current enrollment in any investigational study wherein patient participation has not been completed.
  13. 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.
  14. 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.
  15. Pregnancy, breast-feeding or plans to become pregnant in female of child bearing potential.
  16. Any patient who in the opinion of the investigator would not be a good candidate for enrollment.

Angiographic Exclusion Criteria

  1. Early bifurcation of the main renal artery preventing complete embolic protection of the kidney with the FiberNet.
  2. Fibromuscular Dysplasia.
  3. Presence of thrombus at the lesion site.
  4. Non-ostial atherosclerosis (lesion >15mm from the renal ostium).
  5. 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.
  6. Severe calcification likely to prevent the passage of the device. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674505

Locations
United States, California
VIVA Physicians Inc.
San Jose, California, United States, 95123
Sponsors and Collaborators
VIVA Physicians
Lumen Biomedical
Prairie Education and Research Cooperative
  More Information

No publications provided by VIVA Physicians

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John R. Laird, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT00674505     History of Changes
Other Study ID Numbers: G070189/S002
Study First Received: May 6, 2008
Last Updated: February 16, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Artery Obstruction
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014