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

December 8, 2010
November 5, 2013
December 2010
November 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01257438 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis
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)

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Restenosis
  • Device: Fluency Plus Endovascular Stent Graft
    Treatment of in-stent restenosis
  • Device: PTA only
    Treatment of in-stent restenosis
  • Experimental: Fluency
    Fluency Plus Endovascular Stent Graft
    Intervention: Device: Fluency Plus Endovascular Stent Graft
  • Active Comparator: PTA only
    Intervention: Device: PTA only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
232
October 2015
November 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01257438
BPV-08-002
Yes
C. R. Bard
C. R. Bard
Not Provided
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
C. R. Bard
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP