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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01257438
First received: December 8, 2010
Last updated: November 5, 2013
Last verified: July 2013
  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 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 Phase
Restenosis
Device: Fluency Plus Endovascular Stent Graft
Device: PTA only
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 AV Access Venous Outflow Circuit (RESCUE)

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    PLP is defined as the interval after the index intervention until the next reintervention at the original treatment site or until the extremity is abandoned for permanent access.


Estimated Enrollment: 232
Study Start Date: December 2010
Estimated Study Completion Date: October 2015
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluency
Fluency Plus Endovascular Stent Graft
Device: Fluency Plus Endovascular Stent Graft
Treatment of in-stent restenosis
Active Comparator: PTA only Device: PTA only
Treatment of in-stent restenosis

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

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
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014