Post-Approval Study for the FLAIR Endovascular Stent Graft

NCT00677235 | Completed Results

• 1 other identifier: BPV-07-002
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stenosis of Vascular Prosthetic Devices, Implants and Grafts

Keywords

Hemodialysis; Vascular Prosthesis; Stenosis; End-stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure

  Patient Follow-Up

• Post-Intervention Assisted Primary Patency at 12 Months

  12 months

• Post-intervention Secondary Patency (PSP) at 12 Months

  12 months

• Procedural Success

  Patient Follow-Up

• Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure

  Patient Follow-Up

Study Arms (2)

FLAIR

EXPERIMENTAL

FLAIR Endovascular Stent Graft

Device: FLAIR Endovascular Stent Graft

PTA Only

ACTIVE COMPARATOR

Percutaneous Transluminal Angioplasty

Procedure: PTA

Interventions

FLAIR Endovascular Stent Graft DEVICE

Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft

FLAIR

PTA PROCEDURE

Treatment of stenoses with PTA only

PTA Only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Access Connections

Bamberg, South Carolina, 29003, United States

Location

Related Publications (1)

• 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.

  PMID: 27388566 RESULT

MeSH Terms

Conditions

Constriction, Pathologic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: John Van Vleet
• Organization: Bard Peripheral Vascular

John.VanVleet@CRBard.com

1-800-321-4254

Study Officials

• Ziv Haskal, MD

  University of Maryland Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 14, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 10, 2017
• Results First Posted: August 7, 2014

Record last verified: 2017-01

Locations

US (1)