Trial Outcomes & Findings for Pivotal Study for the FLAIR Endovascular Stent Graft (NCT NCT00678249)

NCT ID: NCT00678249

Last Updated: 2011-05-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 227 participants
• Primary outcome timeframe: 6 month follow-up
• Results posted on: 2011-05-11

Participant Flow

Participant milestones

Measure	FLAIR Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only Percutaneous Transluminal Angioplasty	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.
Overall Study STARTED	97	93	37
Overall Study COMPLETED	97	93	37
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pivotal Study for the FLAIR Endovascular Stent Graft

Baseline characteristics by cohort

Measure	FLAIR n=97 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=93 Participants Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=37 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.	Total n=227 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	50 Participants n=7 Participants	21 Participants n=5 Participants	123 Participants n=4 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants	43 Participants n=7 Participants	16 Participants n=5 Participants	104 Participants n=4 Participants
Age Continuous	61.83 years STANDARD_DEVIATION 14.63 • n=5 Participants	59.83 years STANDARD_DEVIATION 13.58 • n=7 Participants	62.16 years STANDARD_DEVIATION 11.84 • n=5 Participants	60.36 years STANDARD_DEVIATION 14.09 • n=4 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	57 Participants n=7 Participants	23 Participants n=5 Participants	144 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	36 Participants n=7 Participants	14 Participants n=5 Participants	83 Participants n=4 Participants
Region of Enrollment United States	97 participants n=5 Participants	93 participants n=7 Participants	37 participants n=5 Participants	227 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 month follow-up

Population: 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.

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.

Outcome measures

Measure	FLAIR n=91 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=86 Participants Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=35 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.
Percent of Participants With Treatment Area Primary Patency (TAPP)	51 Percentage of Participants	23 Percentage of Participants	60 Percentage of Participants

SECONDARY outcome

Timeframe: 6 month Follow-Up

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.

Outcome measures

Measure	FLAIR n=97 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=93 Participants Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=37 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.
Total Number of Adverse Events	106 total events	106 total events	33 total events

SECONDARY outcome

Timeframe: Index Procedure

Population: The PTA Only group was not analyzed for this outcome measure because it is for successful delivery of the FLAIR study device (PTA Only is the control arm).

The ability to successfully deliver the FLAIR™ Endovascular Stent Graft. Successful delivery is the ability to deliver and seat the implant in the intended location of a stenosed segment of the venous anastomosis region of a synthetic access graft. This attribute is only applicable to the FLAIR and FLAIR Roll-in arms.

Outcome measures

Measure	FLAIR n=97 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=37 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.
Percent of Participants With Successful Delivery of the Device	99 Percentage of Participants	—	100 Percentage of Participants

SECONDARY outcome

Timeframe: Index Procedure

Procedural Success was defined as anatomic success (<30% residual stenosis) and at least one indicator of hemodynamic or clinical success

Outcome measures

Measure	FLAIR n=97 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=93 Participants Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=37 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.
Percent of Participants With Procedural Success	94 Percentage of Participants	73 Percentage of Participants	95 Percentage of Participants

SECONDARY outcome

Timeframe: 2 month Follow-Up

Population: 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.

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.

Outcome measures

Measure	FLAIR n=96 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=92 Participants Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=37 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.
Percent of Participants With TAPP	80 Percentage of Participants	77 Percentage of Participants	89 Percentage of Participants

SECONDARY outcome

Timeframe: 6 month Follow-Up

Population: 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.

ACCP defined as patency (open to blood flow) following the index study procedure until access thrombosis or an intervention of a lesion anywhere within the access circuit.

Outcome measures

Measure	FLAIR n=92 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=86 Participants Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=35 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.
Percent of Participants With Access Circuit Primary Patency (ACPP)	38 Percentage of Participants	20 Percentage of Participants	43 Percentage of Participants

SECONDARY outcome

Timeframe: 6 month Follow-Up

Population: 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.

ACAPP defined as patency (open to blood flow)following the index study procedure until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit.

Outcome measures

Measure	FLAIR n=90 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=84 Participants Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=35 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.
Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)	66 Percentage of Participants	74 Percentage of Participants	66 Percentage of Participants

SECONDARY outcome

Timeframe: 6 month Follow-Up

Population: 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.

ACCP defined as patency (open to blood flow) following the index study procedure until the access is surgically revised or abandoned because of the inability to treat the original lesion. Multiple treatments for occlusions to restore patency are compatible with ACCP.

Outcome measures

Measure	FLAIR n=91 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=85 Participants Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=35 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.
Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)	81 Percentage of Participants	86 Percentage of Participants	91 Percentage of Participants

SECONDARY outcome

Timeframe: 6 month Follow-Up

Population: If a participant was lost to follow-up prior to the follow-up interval window (or the core lab could not assess the angiogram), then the participant's status was considered missing for that time point and was not included in the ITT analysis.

Binary restenosis defined as lesions with greater than or equal to 50% diameter stenosis of the treatment area (calculated by a core lab).

Outcome measures

Measure	FLAIR n=76 Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=67 Participants Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=28 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.
Percent of Participants With Binary Restenosis	28 Percentage of Participants	78 Percentage of Participants	25 Percentage of Participants

Adverse Events

FLAIR

Serious events: 5 serious events

Other events: 67 other events

Deaths: 0 deaths

PTA Only

Serious events: 5 serious events

Other events: 80 other events

Deaths: 0 deaths

FLAIR Roll-In Participants

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	FLAIR n=97 participants at risk Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=93 participants at risk Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=37 participants at risk 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.
Cardiac disorders Death	5.3% 5/95 • Number of events 5 • 6 months	5.6% 5/90 • Number of events 5 • 6 months	2.8% 1/36 • Number of events 1 • 6 months

Other adverse events

Measure	FLAIR n=97 participants at risk Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	PTA Only n=93 participants at risk Percutaneous Transluminal Angioplasty	FLAIR Roll-In Participants n=37 participants at risk 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.
Infections and infestations Infection	6.3% 6/95 • Number of events 6 • 6 months	2.2% 2/90 • Number of events 2 • 6 months	0.00% 0/36 • 6 months
Vascular disorders Stenosis	40.0% 38/95 • Number of events 38 • 6 months	76.7% 69/90 • Number of events 69 • 6 months	41.7% 15/36 • Number of events 15 • 6 months
Vascular disorders Thrombotic Occlusion	32.6% 31/95 • Number of events 31 • 6 months	21.1% 19/90 • Number of events 19 • 6 months	33.3% 12/36 • Number of events 12 • 6 months
Vascular disorders Vessel rupture	3.2% 3/95 • Number of events 3 • 6 months	1.1% 1/90 • Number of events 1 • 6 months	0.00% 0/36 • 6 months
Vascular disorders Pseudoaneurysm	5.3% 5/95 • Number of events 5 • 6 months	2.2% 2/90 • Number of events 2 • 6 months	2.8% 1/36 • Number of events 1 • 6 months
Vascular disorders Hematoma	2.1% 2/95 • Number of events 2 • 6 months	0.00% 0/90 • 6 months	0.00% 0/36 • 6 months
Blood and lymphatic system disorders Signficant arm or hand edema	3.2% 3/95 • Number of events 3 • 6 months	2.2% 2/90 • Number of events 2 • 6 months	2.8% 1/36 • Number of events 1 • 6 months
Vascular disorders Steal syndrome	2.1% 2/95 • Number of events 2 • 6 months	1.1% 1/90 • Number of events 1 • 6 months	2.8% 1/36 • Number of events 1 • 6 months
Cardiac disorders Congestive heart failure	4.2% 4/95 • Number of events 4 • 6 months	2.2% 2/90 • Number of events 2 • 6 months	2.8% 1/36 • Number of events 1 • 6 months
Nervous system disorders Cerebrovascular accident	2.1% 2/95 • Number of events 2 • 6 months	3.3% 3/90 • Number of events 3 • 6 months	0.00% 0/36 • 6 months
Surgical and medical procedures Device migration	4.2% 4/95 • Number of events 4 • 6 months	0.00% 0/90 • 6 months	0.00% 0/36 • 6 months
Surgical and medical procedures Permanent deformation of the Endoluminal Device	1.1% 1/95 • Number of events 1 • 6 months	0.00% 0/90 • 6 months	2.8% 1/36 • Number of events 1 • 6 months

Additional Information

John Reviere, Director, Clinical Affairs

Bard Peripheral Vascular, Inc.

Phone: 480-303-2644

Email: john.reviere@crbard.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place