FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

NCT01257438 | Completed Results DMC

• 1 other identifier: BPV-08-002
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 23

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.

Conditions

Restenosis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Access Circuit Primary Patency (ACPP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following Percutaneous Transluminal Angioplasty (PTA)) Over PTA Alone Through Six Months.

  Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success.

  6 months

• Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.

  Safety rates measured for the randomized subjects population (both Arteriovenous (AV) Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.

  30 days

Secondary Outcomes (1)

• Percentage of Participants With Primary Lesion Patency (PLP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through Six Months in the Treatment of In-stent Restenotic Lesions.

  6 months

Study Arms (2)

Fluency Plus Endovascular Stent Graft

EXPERIMENTAL

Fluency Plus Endovascular Stent Graft

Device: Fluency Plus Endovascular Stent Graft

Percutaneous Transluminal Angioplasty

ACTIVE COMPARATOR

Percutaneous Transluminal Angioplasty only

Device: Percutaneous Transluminal Angioplasty only

Interventions

Fluency Plus Endovascular Stent Graft DEVICE

Treatment of in-stent restenosis

Fluency Plus Endovascular Stent Graft

Percutaneous Transluminal Angioplasty only DEVICE

Treatment of in-stent restenosis

Percutaneous Transluminal Angioplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (23)

University of Alabama Radiology Dept

Birmingham, Alabama, 35294, United States

Location

Southwest Kidney Institute Inc

Phoenix, Arizona, 85004, United States

Location

Arizona Kidney Disease & Hypertension Center-Surgery Center

Phoenix, Arizona, 85012, United States

Location

Capital Nephrology Access Center

Sacramento, Arizona, 95815, United States

Location

Angiocare LLC w/Renal Care Associates PC

Tucson, Arizona, 85719, United States

Location

Greater Long Beach Vascular Access Center

Bellflower, California, 90706, United States

Location

Ladenheim Dialysis Access Centers

Fresno, California, 93710, United States

Location

American Access Care Connecticut Image Guided Surgery

Fairfield, Connecticut, 06825, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Vascular & Interventional Care Center

Augusta, Georgia, 30901, United States

Location

Savannah Vascular Surgery

Savannah, Georgia, 31404, United States

Location

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

Hinsdale, Illinois, 60521, United States

Location

The Vascular Access Center

West Springfield, Massachusetts, 01089, United States

Location

ProHEALTH Care Associates LLP

Lake Success, New York, 11042, United States

Location

Capital Access Center

Raleigh, North Carolina, 27610, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Providence Access Care

Providence, Rhode Island, 02906, United States

Location

Premeire Vascular Access and Imaging Center

Knoxsville, Tennessee, 37919, United States

Location

Renal Associates, P.A. Research Division

San Antonio, Texas, 78215, United States

Location

American Access Care of Richmond

Richmond, Virginia, 23230, United States

Location

University of Wisconsin School of Medicine & Public Health

Madison, Wisconsin, 53792, United States

Location

Midwest Nephrology Associates Vascular Access Center

Milwaukee, Wisconsin, 53215, United States

Location

Results Point of Contact

• Title: Josh Smale, Associate Director Clinical Affairs
• Organization: Bard Peripheral Vascular

Josh.Smale@crbard.com

(480) 603-8140

Study Officials

• Abigail Falk, M.D.

  Access Center of New Jersey

  PRINCIPAL INVESTIGATOR

• Ivan Maya, MD

  Nephrology Associates of Central Florida

  PRINCIPAL INVESTIGATOR

• Alexander Yevzlin, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2016
• Last Updated: January 9, 2017
• Results First Posted: January 9, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)