FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

NCT ID: NCT01257438

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2016-01-31

Brief Summary

The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the Arteriovenous (AV) access circuit of hemodialysis patients with either of the two predominant vascular access types - those with an AV graft and those with an AV fistula.

Detailed Description

This study will compare the use of the FLUENCY® PLUS Endovascular Stent Graft (following Percutaneous Transluminal Angioplasty (PTA)) to PTA alone.

Conditions

Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluency Plus Endovascular Stent Graft

Fluency Plus Endovascular Stent Graft

Group Type: EXPERIMENTAL

Fluency Plus Endovascular Stent Graft

Intervention Type: DEVICE

Treatment of in-stent restenosis

Percutaneous Transluminal Angioplasty

Percutaneous Transluminal Angioplasty only

Group Type: ACTIVE_COMPARATOR

Percutaneous Transluminal Angioplasty only

Intervention Type: DEVICE

Treatment of in-stent restenosis

Interventions

Fluency Plus Endovascular Stent Graft

Treatment of in-stent restenosis

Intervention Type: DEVICE

Percutaneous Transluminal Angioplasty only

Treatment of in-stent restenosis

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
• Patient must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
• Patient must be willing to comply with the protocol requirements, including the follow-up procedures, and be contacted by telephone.
• Patient must have an AV access graft (implanted for ≥ 30 days) or mature fistula located in an arm, and must have undergone at least one successful dialysis session prior to the index procedure.
• Patient must have a previously-placed bare metal stent located in the venous outflow of the AV access circuit in which a ≥ 50% stenosis originates.
• The entire target lesion must be located in the restenosed bare metal stent and extend to no more than 3 cm outside of the bare metal stent.
• The target lesion must be ≤ 10 cm in length.
• After angiography, the operator must judge that the lesion is amenable to angioplasty.
• The reference vessel diameter at the restenosed bare metal stent must be between 5.0 mm and 12.0 mm.
• Additional stenotic lesions (≥ 50%) in the venous outflow that are > 3cm from the edge of the target lesion must be successfully treated (defined as < 30% residual stenosis) prior to the index procedure.

Exclusion Criteria

• The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
• The target lesion has a reference vessel diameter that is larger than 12.0 mm.
• The patient has an infected AV access graft/fistula or uncontrolled systemic infection.
• A pseudoaneurysm is present within the target lesion.
• The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be deployed across the elbow joint.
• The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be deployed at or across the segment of graft or fistula utilized for dialysis needle puncture (i.e., "cannulation zone").
• The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft cross the cephalic arch (perpendicular portion of the cephalic vein in the region of the deltopectoral groove before its junction with the axillary vein).
• The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be placed in the Superior Vena Cava.
• The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft is placed across an angle that is greater than 90 degrees.
• The restenosed bare metal stent is fractured, as verified by angiography per institution's standard of care.
• The patient has a known uncontrolled blood coagulation disorder.
• The patient has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated.
• The patient has a known hypersensitivity to nickel-titanium.
• The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
• The patient is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abigail Falk, M.D.

Role: PRINCIPAL_INVESTIGATOR

Access Center of New Jersey

Ivan Maya, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology Associates of Central Florida

Alexander Yevzlin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Alabama Radiology Dept

Birmingham, Alabama, United States

Southwest Kidney Institute Inc

Phoenix, Arizona, United States

Arizona Kidney Disease & Hypertension Center-Surgery Center

Phoenix, Arizona, United States

Capital Nephrology Access Center

Sacramento, Arizona, United States

Angiocare LLC w/Renal Care Associates PC

Tucson, Arizona, United States

Greater Long Beach Vascular Access Center

Bellflower, California, United States

Ladenheim Dialysis Access Centers

Fresno, California, United States

American Access Care Connecticut Image Guided Surgery

Fairfield, Connecticut, United States

Yale University

New Haven, Connecticut, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Vascular & Interventional Care Center

Augusta, Georgia, United States

Savannah Vascular Surgery

Savannah, Georgia, United States

MakrisMD, LLC, d/b/a Chicago Access Care

Hinsdale, Illinois, United States

The Vascular Access Center

West Springfield, Massachusetts, United States

ProHEALTH Care Associates LLP

Lake Success, New York, United States

Capital Access Center

Raleigh, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Providence Access Care

Providence, Rhode Island, United States

Premeire Vascular Access and Imaging Center

Knoxsville, Tennessee, United States

Renal Associates, P.A. Research Division

San Antonio, Texas, United States

American Access Care of Richmond

Richmond, Virginia, United States

University of Wisconsin School of Medicine & Public Health

Madison, Wisconsin, United States

Midwest Nephrology Associates Vascular Access Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

BPV-08-002

Identifier Type: -

Identifier Source: org_study_id