FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis
This trial is active, not recruiting.
|Treatments||fluency plus endovascular stent graft, pta only|
|Sponsor||C. R. Bard|
|Start date||December 2010|
|End date||November 2013|
|Trial size||232 participants|
|Trial identifier||NCT01257438, BPV-08-002|
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 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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||University of Alabama Radiology Dept||no longer recruiting|
|Phoenix, AZ||Southwest Kidney Institute Inc||no longer recruiting|
|Phoenix, AZ||Arizona Kidney Disease & Hypertension Center-Surgery Center||no longer recruiting|
|Sacramento, AZ||Capital Nephrology Access Center||no longer recruiting|
|Tucson, AZ||Angiocare LLC w/Renal Care Associates PC||no longer recruiting|
|Bellflower, CA||Greater Long Beach Vascular Access Center||no longer recruiting|
|Fresno, CA||Ladenheim Dialysis Access Centers||no longer recruiting|
|Fairfield, CT||American Access Care Connecticut Image Guided Surgery||no longer recruiting|
|New Haven, CT||Yale University||no longer recruiting|
|Jacksonville, FL||First Coast Cardiovascular Institute||no longer recruiting|
|Augusta, GA||Vascular & Interventional Care Center||no longer recruiting|
|Savannah, GA||Savannah Vascular Surgery||no longer recruiting|
|Hinsdale, IL||MakrisMD, LLC, d/b/a Chicago Access Care||no longer recruiting|
|West Springfield, MA||The Vascular Access Center||no longer recruiting|
|Lake Success, NY||ProHEALTH Care Associates LLP||no longer recruiting|
|Raleigh, NC||Capital Access Center||no longer recruiting|
|Cleveland, OH||Cleveland Clinic Foundation||no longer recruiting|
|Providence, RI||Providence Access Care||no longer recruiting|
|Knoxsville, TN||Premeire Vascular Access and Imaging Center||no longer recruiting|
|San Antonio, TX||Renal Associates, P.A. Research Division||no longer recruiting|
|Richmond, VA||American Access Care of Richmond||no longer recruiting|
|Madison, WI||University of Wisconsin School of Medicine & Public Health||no longer recruiting|
|Milwaukee, WI||Midwest Nephrology Associates Vascular Access Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Fluency Plus Endovascular Stent Graft
Superiority of the FLUENCY® PLUS Endovascular Stent Graft (following PTA) over PTA alone through six months in the treatment of in-stent restenotic lesions.
time frame: 6 months
Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (following PTA) over PTA alone through 30 days in the treatment of in-stent restenonic lesions.
time frame: 30 days
Superiority of FLUENCY® PLUS Endovascular Stent Graft (following PTA) over PTA alone through six months in the treatment of in-stent restenonic lesions.
time frame: 6 months
Male or female participants at least 21 years old.
- 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.
- 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.
|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 AV Access Venous Outflow Circuit (RESCUE)|
|Principal investigator||Abigail Falk, M.D.|
|Description||This study will compare the use of the FLUENCY® PLUS Endovascular Stent Graft (following PTA) to PTA alone.|
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