Stenosis of Vascular Prosthetic Devices, Implants and GraftsRENOVANCT00677235

Post-Approval Study for the FLAIR Endovascular Stent Graft

A study testing FLAIR Endovascular Stent Graft and PTA in people with Stenosis of Vascular Prosthetic Devices, Implants and Grafts, run by C. R. Bard at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Stenosis of Vascular Prosthetic Devices, Implants and Grafts
What is being tested?: FLAIR Endovascular Stent Graft and PTA
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 1 siteUnited States
Study dates: Dec 2008to Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Access Connections
Bamberg, South Carolina, 29003

Other trials in United States

About this study

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

Read the 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.

Conditions: Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Being tested: FLAIR Endovascular Stent Graft, PTA
Keywords: Hemodialysis, Vascular Prosthesis, Stenosis, End-stage Renal Disease (ESRD)
Medical subject headings: Constriction, Pathologic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FLAIR Endovascular Stent GraftDevice
Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
PTAProcedure or surgery
Treatment of stenoses with PTA only

Study groups in NCT00677235
Study group	Role	What they receive
FLAIR	Experimental	FLAIR Endovascular Stent Graft Receives: Device: FLAIR Endovascular Stent Graft
PTA Only	Active comparator	Percutaneous Transluminal Angioplasty Receives: Procedure: PTA

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 months
The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
To Estimate Safety at 24 Months.
To estimate the percentage of participants without safety issues through 24 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Mar 2013

First posted14 May 2008 (estimated)
Study startDec 2008
Primary completionDec 2012
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stenosis of Vascular Prosthetic Devices, Implants and GraftsStudies of the same condition, open and under way.
More trials run by C. R. BardThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00677235
Sponsor's protocol ID: BPV-07-002
Acronym: RENOVA
Status last verified: Jan 2017
First submitted: 12 May 2008
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 27388566

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Concurrently-Controlled Post-Approval Study of the FLAIR Endovascular Stent Graft
ClinicalTrials.gov ID: NCT00677235
Acronym / sponsor ID: RENOVA / BPV-07-002
Conditions: Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Keywords: Hemodialysis, Vascular Prosthesis, Stenosis, End-stage Renal Disease (ESRD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Dec 2012 (actual)
Study completion: Mar 2013 (actual)
First posted: 14 May 2008 (estimated)
Results: Posted 7 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FLAIR	Experimental	Device: FLAIR Endovascular Stent GraftFLAIR Endovascular Stent Graft
PTA Only	Active comparator	Procedure: PTAPercutaneous Transluminal Angioplasty

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FLAIR Endovascular Stent GraftTreatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft	Device	FLAIR
PTATreatment of stenoses with PTA only	Procedure or surgery	PTA Only

Primary outcome

ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.
Time frame: 12 months
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 Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.
Time frame: 12 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 arteriovenous (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

13 secondary outcomes

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
Post-Intervention Assisted Primary Patency at 12 Months
Time frame: 12 months
Post-intervention Secondary Patency (PSP) at 12 Months
Time frame: 12 months
Procedural Success
Time frame: Patient Follow-Up
Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure
Time frame: Patient Follow-Up
Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months
Time frame: 12 months
Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention.
Time frame: 24 months
To Estimate Safety at 24 Months.
Time frame: 24 months
Post-Intervention Assisted Primary Patency at 24 Months
Time frame: 24 month follow up
Post-intervention Secondary Patency at 24 Months
Time frame: 24 months
Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.
Time frame: 24 months
Post-Intervention Assisted Primary Patency at 6 Months
Time frame: 6 month follow up
Post-intervention Secondary Patency at 6 Months
Time frame: 6 month follow-up

Results and safety

Results posted to the registry on 7 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLAIR	138	97
PTA Only	132	94

Primary outcome: ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.

Time frame: 12 months. Number (95% Confidence Interval). Unit: proportion of participants

Measure	FLAIR n = 138	PTA Only n = 132
Value	0.240 (0.165 to 0.315)	0.110 (0.054 to 0.167)

Population analysed: All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).

Primary outcome: 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.

Time frame: 12 months. Least squares mean (Standard Deviation). Unit: Months/intervention

Measure	FLAIR n = 138	PTA Only n = 132
Value	5.2 (4.08)	4.4 (3.51)

Population analysed: All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.

Primary outcome: The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.

Time frame: 12 months. Number. Unit: Number of Participants with Device and/o

Measure	FLAIR n = 128	PTA Only n = 130
Value	128	130

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Index Procedure through 24 months of follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FLAIR	84 of 138 (60.9%)	128 of 138 (92.8%)	Not reported
PTA Only	87 of 132 (65.9%)	127 of 132 (96.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27388566Haskal 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ziv Haskal, MD principal investigator

University of Maryland Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FLAIR Endovascular Stent Graft and PTA in people with Stenosis of Vascular Prosthetic Devices, Implants and Grafts, run by C. R. Bard at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00677235, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.