Pivotal Study for the FLAIR Endovascular Stent Graft | NCT00678249

NCT00678249

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
P060002	Other Identifier	Food and Drug Administration

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FLAIR	Experimental	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Device: FLAIR Endovascular Stent Graft
PTA Only	Active Comparator	Percutaneous Transluminal Angioplasty	Procedure: PTA
FLAIR Roll-in Participants	Experimental	Primary Patency followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.	Device: FLAIR Endovascular Stent Graft

Name	Type	Description	Arm Group Labels	Other Names
FLAIR Endovascular Stent Graft	Device	Primary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft	FLAIR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of Participants With Treatment Area Primary Patency (TAPP)	TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.	6 month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Total Number of Adverse Events	The safety endpoint was evaluated based on the incidence of adverse events observed within the same time interval. An adverse event was defined as any undesirable clinical occurrence in a patient that (a) is considered possibly or definietly device related by the investigator, (b) involves the access circuit (AV graft arterial anastomosis to the superior vena cava-right atrial junction) or the arm where the access circuit is located or (c) the investigator considers relevant to the objectives of this study. An adverse event could be mild, moderate or severe.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients between 18 to 90 years of age whose hemodialysis access was a synthetic AV access graft located in an arm.
Angiographic evidence of one or more stenoses, 7 cm or less in length and greater than or equal to 50%, at the graft-vein anastomosis of a synthetic AV access graft. The entire lesion must have been located within 7 cm of the anastomosis such that approximately 1 cm of the IMPRA/Bard Device must have extended into non-diseased vein and approximately 1 cm, but no more than 2 cm, of the IMPRA/Bard Device will be extended into non-diseased AV graft.
Clinical evidence of a hemodynamically significant stenosis.
Percutaneous endovascular therapy for the identified lesion was the best treatment choice in the opinion of the investigator.
Patients must have been able to understand and provide informed consent.
Patients whose synthetic AV access grafts had been implanted greater than 30 days and had undergone 1 or more successful hemodialysis sessions.
During primary balloon angioplasty, full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, must have been achieved.

Exclusion Criteria:

Concomitant disease (e.g., terminal cancer) or other medical condition that was likely to result in death of the patient within 6 months of the time of implantation.
Stenoses that had a corresponding thrombosis treated within 7 days.
The presence of a second lesion in the access circuit less than or equal to 3 cm from the edges of the primary lesion that was treated within 30 days or that was greater than or equal to 30%. Access circuit was defined as the area from the AV access graft arterial anastomosis to the superior vena cava-right atrial junction.
The presence of a second lesion in the access circuit greater than 3 cm from the edges of the primary lesion that was greater than or equal to 30%. Second lesions that were greater than or equal to 30% must have been treated prior to patient inclusion to reduce the percent stenosis to less than 30%.
Patients who were unwilling or unable to return for follow-up visits or patients with whom follow-up visits may have been unreliable.
Patients who had a stent placed at the target lesion site.
Patients with a blood coagulative disorder or sepsis.
Patients in which the IMPRA/Bard Device would have been required to cross an angle (between the inflow vein and synthetic AV access graft) that was greater than 90 degrees.
Patients in which the IMPRA/Bard Device would have been required to be deployed fully across the elbow joint, which is identified radiographically by a combination of the humeroulnar joint and the humeroradial joint.
Patients with a contraindication to the use of contrast media.
Patients whose AV access graft was infected.
Patients who were currently or were scheduled to enroll in other investigations that conflicted with follow-up testing or confounds data in this trial.
Procedural use of another investigational device.
Patients who were pregnant.

Name	Affiliation	Role
David Ciavarella, MD	C. R. Bard	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
New York Presbyterian Hospital/Columbia		New York	New York	10032	United States

PubMed Identifier	Type	Citation	Retractions
20147715	Derived	Haskal ZJ, Trerotola S, Dolmatch B, Schuman E, Altman S, Mietling S, Berman S, McLennan G, Trimmer C, Ross J, Vesely T. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010 Feb 11;362(6):494-503. doi: 10.1056/NEJMoa0902045.

ID	Title	Description
FG000	FLAIR	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
FG001	PTA Only	Percutaneous Transluminal Angioplasty
FG002	FLAIR Roll-In Participants	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.

Baseline Characteristics Module

ID	Title	Description
BG000	FLAIR	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
BG001	PTA Only	Percutaneous Transluminal Angioplasty

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent of Participants With Treatment Area Primary Patency (TAPP)

TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.

If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.

Posted

Number

Percentage of Participants

6 month follow-up

ID	Title	Description
OG000	FLAIR	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
OG001	PTA Only

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FLAIR	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms