Overview

This trial is active, not recruiting.

Condition restenosis
Treatments fluency plus endovascular stent graft, pta only
Phase phase 2
Sponsor C. R. Bard
Start date December 2010
End date November 2013
Trial size 232 participants
Trial identifier NCT01257438, BPV-08-002

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 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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Fluency Plus Endovascular Stent Graft
fluency plus endovascular stent graft
Treatment of in-stent restenosis
(Active Comparator)
pta only
Treatment of in-stent restenosis

Primary Outcomes

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
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by C. R. Bard.