Post-Approval Study for the FLAIR Endovascular Stent Graft (RENOVA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00677235
First received: May 12, 2008
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.


Condition Intervention Phase
Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Device: FLAIR Endovascular Stent Graft
Procedure: PTA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Concurrently-Controlled Post-Approval Study of the FLAIR Endovascular Stent Graft

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

Primary Outcome Measures:
  • ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.

  • The Index of Patency Function (IPF) [the Average Number of Days Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.

  • The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure [ Time Frame: Patient Follow-Up ] [ Designated as safety issue: No ]
    The estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.

  • Post-Intervention Assisted Primary Patency at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    PAPP at 12 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.

  • Post-intervention Secondary Patency at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    PSP (referred to as Access Circuit Cumulative Patency, ACCP, in the pivotal trial) at 12 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.

  • Procedural Success [ Time Frame: Patient Follow-Up ] [ Designated as safety issue: No ]
    Procedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success.

  • Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure [ Time Frame: Patient Follow-Up ] [ Designated as safety issue: No ]
    The incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the BPV clinician training program.

  • Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Serious Adverse Events at 12 months are reported for all 270 subjects.

  • ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention at 24 Months. Procedure Until the Next Access Thrombosis or Reintervention. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To estimate patency at 24 months. ACPP was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.

  • To Estimate Safety at 24 Months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To estimate the percentage of participants wihtout safety issues through 24 months.

  • Post-Intervention Assisted Primary Patency at 24 Months [ Time Frame: 24 month follow up ] [ Designated as safety issue: No ]
    PAPP at 24 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.

  • Post-intervention Secondary Patency at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    PSP (referred to as Access Circuit Cumulative Patency, ACCP, in the pivotal trial) at 24 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.

  • Index of Patency Function (IPF) [the Average Number of Days Between Interventions] Rates of FLAIR™ and PTA at at 24 Months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.

  • Post-Intervention Assisted Primary Patency at 6 Months [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    PAPP at 6 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.

  • Post-intervention Secondary Patency at 6 Months [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    PSP (referred to as Access Circuit Cumulative Patency, ACCP, in the pivotal trial) at 6 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.


Enrollment: 270
Study Start Date: December 2008
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLAIR
FLAIR Endovascular Stent Graft
Device: FLAIR Endovascular Stent Graft
Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
Active Comparator: PTA Only
Percutaneous Transluminal Angioplasty
Procedure: PTA
Treatment of stenoses with PTA only

Detailed Description:

The purpose of the study is to compare efficacy data on subjects randomized to treatment with percutaneous transluminal angioplasty (PTA) and the FLAIR™ Endovascular Stent Graft versus subjects randomized to treatment with PTA only.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be either a male or non-pregnant female greater than or equal to 21 years of age
  • Subject is willing to comply with the protocol requirements and can be contacted by telephone
  • Subject has a synthetic AV access graft located in an arm that has been implanted for greater than or equal to 30 days and has undergone at least one successful dialysis session prior to the index procedure
  • Angiographic evidence (per the institution's standard) is available to indicate that the subject has a stenosis greater than or equal to 50% located at the graft-vein anastomosis of subject's synthetic AV access graft
  • The target lesion is estimated to be less than or equal to 7 cm in length (by angiography)
  • The entire target lesion is located within 7 cm of the graft-vein anastomosis, as verified by angiography, such that approximately 1 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased vein and approximately 1 cm but no more than 2 cm of the FLAIR™ Endovascular Stent Graft will extend into the non-diseased AV graft
  • Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty
  • Graft diameter at the deployment site is between 5 mm and 8 mm as verified by angiography

Exclusion Criteria:

  • The subject has a life expectancy of < 25 months.
  • The target lesion has had a corresponding thrombosis treated less than or equal to 7 days prior to the index procedure.
  • A previously placed stent and/or stent graft located in the treatment area is present. Treatment area includes the entire target lesion and 1 cm of landing zone into both non-diseased AV graft and non-diseased vein.
  • The subject has an infected AV access graft or uncontrolled systemic infection.
  • The presence of additional lesion(s) in the access circuit less than or equal to 3 cm from the edges of the target lesion that was treated less than or equal to 30 days prior to index procedure.
  • The presence of additional lesion(s) in the access circuit > 3 cm from the edges of the primary lesion that are greater than or equal to 30% stenosed. NOTE: Subjects may be included if the additional lesions(s) can be successfully treated with a final residual stenosis of < 30% prior to the index procedure.
  • The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft be deployed fully across the elbow joint (radiographically identified by a combination of the humeroulnar joint and the humeroradial joint).
  • The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft cross an angle (between the inflow vein and synthetic AV access graft) that is > 90 degrees.
  • The subject has an uncontrolled blood coagulation disorder.
  • The subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated.
  • The subject has a known hypersensitivity to nickel-titanium.
  • Subjects who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial.
  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: NCT00677235

Locations
United States, South Carolina
Access Connections
Bamberg, South Carolina, United States, 29003
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Ziv Haskal, MD University of Maryland Hospital
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00677235     History of Changes
Other Study ID Numbers: BPV-07-002
Study First Received: May 12, 2008
Results First Received: January 20, 2014
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
Hemodialysis
Vascular Prosthesis
Stenosis
ESRD

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 21, 2014