Clinical trial NCT01257438: FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis
Official title: Prospective, Multi-Center, Randomized, Concurrently-Controlled Study of the FLUENCY® PLUS Endovascular Stent Graft in the Treatment of In-stent Restenosis in the Arteriovenous (AV) Access Venous Outflow Circuit (RESCUE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restenosis
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 275
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.
timeFrame: 30 days
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Radiology Dept
state: Alabama
city: Phoenix
country: United States
facility: Southwest Kidney Institute Inc
state: Arizona
city: Phoenix
country: United States
facility: Arizona Kidney Disease & Hypertension Center-Surgery Center
state: Arizona
city: Sacramento
country: United States
facility: Capital Nephrology Access Center
state: Arizona
city: Tucson
country: United States
facility: Angiocare LLC w/Renal Care Associates PC
state: Arizona
city: Bellflower
country: United States
facility: Greater Long Beach Vascular Access Center
state: California
city: Fresno
country: United States
facility: Ladenheim Dialysis Access Centers
state: California
city: Fairfield
country: United States
facility: American Access Care Connecticut Image Guided Surgery
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Augusta
country: United States
facility: Vascular & Interventional Care Center
state: Georgia
city: Savannah
country: United States
facility: Savannah Vascular Surgery
state: Georgia
city: Hinsdale
country: United States
facility: MakrisMD, LLC, d/b/a Chicago Access Care
state: Illinois
city: West Springfield
country: United States
facility: The Vascular Access Center
state: Massachusetts
city: Lake Success
country: United States
facility: ProHEALTH Care Associates LLP
state: New York
city: Raleigh
country: United States
facility: Capital Access Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Providence
country: United States
facility: Providence Access Care
state: Rhode Island
city: Knoxsville
country: United States
facility: Premeire Vascular Access and Imaging Center
state: Tennessee
city: San Antonio
country: United States
facility: Renal Associates, P.A. Research Division
state: Texas
city: Richmond
country: United States
facility: American Access Care of Richmond
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin School of Medicine & Public Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Midwest Nephrology Associates Vascular Access Center
state: Wisconsin
Study officials:
affiliation: Access Center of New Jersey
name: Abigail Falk, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrology Associates of Central Florida
name: Ivan Maya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Alexander Yevzlin, MD
role: PRINCIPAL_INVESTIGATOR
References: