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

A Prospective, Randomized, Concurrently-Controlled Post-Approval Study of the FLAIR Endovascular Stent Graft

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.

Study Overview

• Status: Completed
• Conditions: Stenosis of Vascular Prosthetic Devices, Implants and Grafts
• Intervention / Treatment: Device: FLAIR Endovascular Stent Graft; Procedure: PTA

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.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Bamberg, South Carolina, United States, 29003
      • Access Connections

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.	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.	12 months
The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.	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 arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis.	12 months
The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.		12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure	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.	Patient Follow-Up
Post-Intervention Assisted Primary Patency at 12 Months	Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.	12 months
Post-intervention Secondary Patency (PSP) at 12 Months	Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.	12 months
Procedural Success	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.	Patient Follow-Up
Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure	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 Bard Peripheral Vascular (BPV) clinician training program.	Patient Follow-Up
Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months	Serious Adverse Events at 12 months are reported for all 270 subjects.	12 months
Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention.	Access Circuit Primary Patency (ACPP) was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.	24 months
To Estimate Safety at 24 Months.	To estimate the percentage of participants without safety issues through 24 months.	24 months
Post-Intervention Assisted Primary Patency at 24 Months	Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.	24 month follow up
Post-intervention Secondary Patency at 24 Months	Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.	24 months
Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.	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.	24 months
Post-Intervention Assisted Primary Patency at 6 Months	Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.	6 month follow up
Post-intervention Secondary Patency at 6 Months	Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.	6 month follow-up

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Ziv Haskal, MD, University of Maryland Hospital

Publications and helpful links

General Publications

• Haskal ZJ, Saad TF, Hoggard JG, Cooper RI, Lipkowitz GS, Gerges A, Ross JR, Pflederer TA, Mietling SW. Prospective, Randomized, Concurrently-Controlled Study of a Stent Graft versus Balloon Angioplasty for Treatment of Arteriovenous Access Graft Stenosis: 2-Year Results of the RENOVA Study. J Vasc Interv Radiol. 2016 Aug;27(8):1105-1114.e3. doi: 10.1016/j.jvir.2016.05.019. Epub 2016 Jul 4.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: May 12, 2008
• First Submitted That Met QC Criteria: May 13, 2008
• First Posted (ESTIMATE): May 14, 2008

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Stenosis; Hemodialysis; Vascular Prosthesis; End-stage Renal Disease (ESRD)
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: BPV-07-002