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FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis (RESCUE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01257438
First received: December 8, 2010
Last updated: November 9, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Restenosis
Device: Fluency Plus Endovascular Stent Graft
Device: Percutaneous Transluminal Angioplasty only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 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.

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


Secondary Outcome Measures:
  • 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. [ Time Frame: 6 months ]
    Primary Lesion Patency (PLP) is defined as the interval after the index intervention until the next re-intervention at the original treatment site or until the extremity is abandoned for permanent access. Freedom from re-intervention is the criteria for success.


Enrollment: 275
Study Start Date: December 2010
Study Completion Date: January 2016
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluency Plus Endovascular Stent Graft
Fluency Plus Endovascular Stent Graft
Device: Fluency Plus Endovascular Stent Graft
Treatment of in-stent restenosis
Active Comparator: Percutaneous Transluminal Angioplasty
Percutaneous Transluminal Angioplasty only
Device: Percutaneous Transluminal Angioplasty only
Treatment of in-stent restenosis

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257438

  Show 23 Study Locations
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: 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
  More Information

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01257438     History of Changes
Other Study ID Numbers: BPV-08-002 
Study First Received: December 8, 2010
Results First Received: July 22, 2015
Last Updated: November 9, 2016
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on February 20, 2017