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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95123
      • VIVA Physicians Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: VIVA Physicians
• Collaborators: Prairie Education and Research Cooperative; Lumen Biomedical

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Anticipated): June 1, 2009

Study Registration Dates

• First Submitted: May 6, 2008
• First Submitted That Met QC Criteria: May 7, 2008
• First Posted (Estimate): May 8, 2008

Study Record Updates

• Last Update Posted (Estimate): February 17, 2010
• Last Update Submitted That Met QC Criteria: February 16, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: G070189/S002