Pivotal Study for the FLAIR Endovascular Stent Graft

• Sponsor: C. R. Bard (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00678249
• Collaborator: (none)
• Enrollment: 227
• Location: 1
• Arms: 3
• Duration (Months): 41
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.

Condition or Disease	Intervention/Treatment	Phase
Stenoses	Device: FLAIR Endovascular Stent Graft; Procedure: PTA; Device: FLAIR Endovascular Stent Graft	N/A

Detailed Description

A total of 227 patients were treated at 16 U.S. investigational sites to evaluate the safety and effectiveness of the FLAIR™ Endovascular Stent Graft. This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.

Study Design

• Study Type: Interventional
• Actual Enrollment: 227 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi-Center, Randomized Evaluation of an IMPRA/Bard ePTFE Encapsulated Carbon Lined Nitinol Endoluminal Device for AV Access Graft Stenoses
• Study Start Date: Jan 1, 2001
• Actual Primary Completion Date: Jun 1, 2004
• Actual Study Completion Date: Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FLAIR Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Device: FLAIR Endovascular Stent Graft; Primary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft; Other Names: Flair Stent Graft
Active Comparator: PTA Only Percutaneous Transluminal Angioplasty	Procedure: PTA; Percutaneous Transluminal Angioplasty; Other Names: Flair Stent Graft
Experimental: FLAIR Roll-in Participants 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; 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.; Other Names: Flair Stent Graft

Outcome Measures

Primary Outcome Measures

1. Percent of Participants With Treatment Area Primary Patency (TAPP) [6 month follow-up]

   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.

Secondary Outcome Measures

1. Total Number of Adverse Events [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.

2. Percent of Participants With Successful Delivery of the Device [Index Procedure]

   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.

3. Percent of Participants With Procedural Success [Index Procedure]

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

4. Percent of Participants With TAPP [2 month Follow-Up]

   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.

5. Percent of Participants With Access Circuit Primary Patency (ACPP) [6 month Follow-Up]

   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.

6. Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP) [6 month Follow-Up]

   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.

7. Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency) [6 month Follow-Up]

   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.

8. Percent of Participants With Binary Restenosis [6 month Follow-Up]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian Hospital/Columbia	New York	New York	United States	10032

Sponsors and Collaborators

• C. R. Bard

Investigators

• Study Director: David Ciavarella, MD, C. R. Bard

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00678249
• Other Study ID Numbers: IMP-9809; P060002
• First Posted: May 15, 2008
• Last Update Posted: May 11, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: Hemodialysis; Vascular Prosthesis; stenoses; grafts
• Additional relevant MeSH terms: Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Period Title: Overall Study
STARTED	97	93	37
COMPLETED	97	93	37
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants	Total
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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 of all reporting groups
Overall Participants	97	93	37	227
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	52 53.6%	50 53.8%	21 56.8%	123 54.2%
>=65 years	45 46.4%	43 46.2%	16 43.2%	104 45.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.83 (14.63)	59.83 (13.58)	62.16 (11.84)	60.36 (14.09)
Sex: Female, Male (Count of Participants)
Female	64 66%	57 61.3%	23 62.2%	144 63.4%
Male	33 34%	36 38.7%	14 37.8%	83 36.6%
Region of Enrollment (participants) [Number]
United States	97 100%	93 100%	37 100%	227 100%

Outcome Measures

1. Primary Outcome

Title	Percent of Participants With Treatment Area Primary Patency (TAPP)
Description	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.
Time Frame	6 month follow-up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Measure Participants	91	86	35
Number [Percentage of Participants]	51 52.6%	23 24.7%	60 162.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FLAIR, PTA Only
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

2. Secondary Outcome

Title	Total Number of Adverse Events
Description	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.
Time Frame	6 month Follow-Up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Measure Participants	97	93	37
Number [total events]	106	106	33

3. Secondary Outcome

Title	Percent of Participants With Successful Delivery of the Device
Description	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.
Time Frame	Index Procedure

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Measure Participants	97	0	37
Number [Percentage of Participants]	99 102.1%	100 107.5%

4. Secondary Outcome

Title	Percent of Participants With Procedural Success
Description	Procedural Success was defined as anatomic success (<30% residual stenosis) and at least one indicator of hemodynamic or clinical success
Time Frame	Index Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Measure Participants	97	93	37
Number [Percentage of Participants]	94 96.9%	73 78.5%	95 256.8%

5. Secondary Outcome

Title	Percent of Participants With TAPP
Description	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.
Time Frame	2 month Follow-Up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Measure Participants	96	92	37
Number [Percentage of Participants]	80 82.5%	77 82.8%	89 240.5%

6. Secondary Outcome

Title	Percent of Participants With Access Circuit Primary Patency (ACPP)
Description	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.
Time Frame	6 month Follow-Up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Measure Participants	92	86	35
Number [Percentage of Participants]	38 39.2%	20 21.5%	43 116.2%

7. Secondary Outcome

Title	Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)
Description	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.
Time Frame	6 month Follow-Up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Measure Participants	90	84	35
Number [Percentage of Participants]	66 68%	74 79.6%	66 178.4%

8. Secondary Outcome

Title	Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)
Description	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.
Time Frame	6 month Follow-Up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Measure Participants	91	85	35
Number [Percentage of Participants]	81 83.5%	86 92.5%	91 245.9%

9. Secondary Outcome

Title	Percent of Participants With Binary Restenosis
Description	Binary restenosis defined as lesions with greater than or equal to 50% diameter stenosis of the treatment area (calculated by a core lab).
Time Frame	6 month Follow-Up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	FLAIR	PTA Only	FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft	Percutaneous Transluminal Angioplasty	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.
Measure Participants	76	67	28
Number [Percentage of Participants]	28 28.9%	78 83.9%	25 67.6%

Adverse Events

Time Frame	6 months
Arm/Group Title	FLAIR		PTA Only		FLAIR Roll-In Participants
Arm/Group Description	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft		Percutaneous Transluminal Angioplasty		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.
All Cause Mortality
	FLAIR		PTA Only		FLAIR Roll-In Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	FLAIR		PTA Only		FLAIR Roll-In Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/97 (5.2%)		5/93 (5.4%)		1/37 (2.7%)
Cardiac disorders
Death	5/95 (5.3%)	5	5/90 (5.6%)	5	1/36 (2.8%)	1
Other (Not Including Serious) Adverse Events
	FLAIR		PTA Only		FLAIR Roll-In Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	67/97 (69.1%)		80/93 (86%)		26/37 (70.3%)
Blood and lymphatic system disorders
Signficant arm or hand edema	3/95 (3.2%)	3	2/90 (2.2%)	2	1/36 (2.8%)	1
Cardiac disorders
Congestive heart failure	4/95 (4.2%)	4	2/90 (2.2%)	2	1/36 (2.8%)	1
Infections and infestations
Infection	6/95 (6.3%)	6	2/90 (2.2%)	2	0/36 (0%)	0
Nervous system disorders
Cerebrovascular accident	2/95 (2.1%)	2	3/90 (3.3%)	3	0/36 (0%)	0
Surgical and medical procedures
Device migration	4/95 (4.2%)	4	0/90 (0%)	0	0/36 (0%)	0
Permanent deformation of the Endoluminal Device	1/95 (1.1%)	1	0/90 (0%)	0	1/36 (2.8%)	1
Vascular disorders
Stenosis	38/95 (40%)	38	69/90 (76.7%)	69	15/36 (41.7%)	15
Thrombotic Occlusion	31/95 (32.6%)	31	19/90 (21.1%)	19	12/36 (33.3%)	12
Vessel rupture	3/95 (3.2%)	3	1/90 (1.1%)	1	0/36 (0%)	0
Pseudoaneurysm	5/95 (5.3%)	5	2/90 (2.2%)	2	1/36 (2.8%)	1
Hematoma	2/95 (2.1%)	2	0/90 (0%)	0	0/36 (0%)	0
Steal syndrome	2/95 (2.1%)	2	1/90 (1.1%)	1	1/36 (2.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.