Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01173718
• Collaborator: (none)
• Enrollment: 138
• Arm: 1
• Duration (Months): 31.1

Study Details

Study Description

Brief Summary

This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs). > >>

A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. >

Subjects will be selected from up to 20 Investigational Sites.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Device: GORE® ACUSEAL Vascular Graft	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 138 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GORE® ACUSEAL Vascular Graft	Device: GORE® ACUSEAL Vascular Graft; Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.

Outcome Measures

Primary Outcome Measures

1. Cumulative Patency at 6 Months [6 Months]

   Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.

2. Freedom From Bleeding at 6 Months [6 Months]

   Percentage of subjects free from both major and minor bleeding events, assessed at 6-months

Secondary Outcome Measures

1. Primary Unassisted Patency at 6 Months [6 Months]

   The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency.

2. Time to Event Analysis (Cumulative Patency) [6 Months]

   The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.

3. Time to First Cannulation [Time of access placement to first cannulation, assessed up to one week]

   The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.

4. Time to Potential Central Venous Catheter Removal [Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123]

   The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:>

1. Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. >

1. Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. > >>

2. The patient must be able to have the vascular access graft placed in an upper extremity. >

1. The patient is 18 years of age or older. >

1. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. >

1. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. > >>

2. The patient or his/her legal guardian is willing to provide informed consent. >

Exclusion Criteria:>

1. The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.>

1. The patient currently has a known or suspected systemic infection.>

1. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>

1. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. >

1. The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.>

1. The patient is enrolled in another investigational study.>

1. The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.>

1. Study device is intended to be used temporarily.>

1. The patient has had >2 previous arteriovenous accesses in treatment arm.>

1. Patient is taking Aggrenox®.>

1. The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.>

1. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(>10 mg), cyclosporine, tacrolimus or cyclophosphamide.>

1. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>

1. Life expectancy is less than 12 months.>

1. The patient is pregnant.>

1. The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

• Principal Investigator: Marc Glickman, MD, Sentara Vascular Specialists

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT01173718
• Other Study ID Numbers: AVG 08-06
• First Posted: Aug 2, 2010
• Last Update Posted: Jul 26, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by W.L.Gore & Associates: Hemodialysis; Vascular Graft
• Additional relevant MeSH terms: Kidney Failure, Chronic

Study Results

Participant Flow

Arm/Group Title	GORE® ACUSEAL Vascular Graft
Arm/Group Description	GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Period Title: Overall Study
STARTED	138
COMPLETED	94
NOT COMPLETED	44

Baseline Characteristics

Arm/Group Title	GORE® ACUSEAL Vascular Graft
Arm/Group Description	GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Overall Participants	138
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (13.8)
Sex: Female, Male (Count of Participants)
Female	71 51.4%
Male	67 48.6%
Region of Enrollment (participants) [Number]
United States	138 100%

Outcome Measures

1. Primary Outcome

Title	Cumulative Patency at 6 Months
Description	Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All subjects with unknown cumulative patency status at the 6 month window were omitted from calculations

Arm/Group Title	GORE® ACUSEAL Vascular Graft
Arm/Group Description	GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Measure Participants	128
Number (95% Confidence Interval) [percentage of participants]	83.6 60.6%

2. Primary Outcome

Title	Freedom From Bleeding at 6 Months
Description	Percentage of subjects free from both major and minor bleeding events, assessed at 6-months
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All subjects with unknown bleeding status at the 6 month window were omitted from calculations

Arm/Group Title	GORE® ACUSEAL Vascular Graft
Arm/Group Description	GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Measure Participants	113
Number (95% Confidence Interval) [percentage of participants]	87.6 63.5%

3. Secondary Outcome

Title	Primary Unassisted Patency at 6 Months
Description	The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All subjects with unknown primary unassisted patency status at the 6 month window were omitted from calculations

Arm/Group Title	GORE® ACUSEAL Vascular Graft
Arm/Group Description	GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Measure Participants	131
Number [percentage of participants]	45 32.6%

4. Secondary Outcome

Title	Time to Event Analysis (Cumulative Patency)
Description	The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All subjects with unknown time to event analysis (cumulative patency) status at the 6 month window were omitted from calculations

Arm/Group Title	GORE® ACUSEAL Vascular Graft
Arm/Group Description	GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Measure Participants	128
Number (95% Confidence Interval) [percentage of participants]	84.2 61%

5. Secondary Outcome

Title	Time to First Cannulation
Description	The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.
Time Frame	Time of access placement to first cannulation, assessed up to one week

Outcome Measure Data

Analysis Population Description

All subjects with unknown time to first cannulation at the 6 month window were omitted from calculations

Arm/Group Title	GORE® ACUSEAL Vascular Graft
Arm/Group Description	GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Measure Participants	135
Cannulated within 24 hours of procedure	22.2
Cannulated within 48 hours of procedure	35.6
Cannulated within 72 hours of procedure	40.0
Cannulated within 1 week of procedure	51.9

6. Secondary Outcome

Title	Time to Potential Central Venous Catheter Removal
Description	The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.
Time Frame	Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123

Outcome Measure Data

Analysis Population Description

All subjects with unknown time to potential central venous catheter removal at the 6 month window were omitted from calculations

Arm/Group Title	GORE® ACUSEAL Vascular Graft
Arm/Group Description	GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Measure Participants	134
Median (Full Range) [days]	15.5

Adverse Events

Arm/Group Title	GORE® ACUSEAL Vascular Graft
Arm/Group Description	GORE® ACUSEAL Vascular Graft
All Cause Mortality
	GORE® ACUSEAL Vascular Graft
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	GORE® ACUSEAL Vascular Graft
	Affected / at Risk (%)	# Events
Total	74/138 (53.6%)
Blood and lymphatic system disorders
Anemia	6/138 (4.3%)	6
Anemia aggravated	1/138 (0.7%)	1
Chronic thrombocytopenia	1/138 (0.7%)	1
Leukocytosis	1/138 (0.7%)	2
Thrombocytopenia	1/138 (0.7%)	1
Cardiac disorders
Acute coronary syndrome	1/138 (0.7%)	1
Atrial fibrillation	2/138 (1.4%)	3
Atrial fibrillation with rapid ventricular response	1/138 (0.7%)	1
Atrial flutter	2/138 (1.4%)	2
Atrial tachycardia	1/138 (0.7%)	1
Cardiac arrest	3/138 (2.2%)	3
Cardiac arrhythmia	1/138 (0.7%)	1
Cardiogenic shock	1/138 (0.7%)	1
Cardiopulmonary arrest	1/138 (0.7%)	1
Chest pain - cardiac	1/138 (0.7%)	1
Congestive heart failure	4/138 (2.9%)	4
Coronary artery disease	1/138 (0.7%)	1
Diastolic heart failure	1/138 (0.7%)	1
Myocardial infarction	1/138 (0.7%)	1
Non ST segment elevation myocardial infarction	1/138 (0.7%)	1
Non STEMI	4/138 (2.9%)	4
Non-sustained ventricular tachycardia	1/138 (0.7%)	1
Pulseless electrical activity	1/138 (0.7%)	1
STEMI	1/138 (0.7%)	1
SVT	1/138 (0.7%)	1
Unstable angina	2/138 (1.4%)	2
Congenital, familial and genetic disorders
Polycystic kidney	1/138 (0.7%)	1
Gastrointestinal disorders
Diabetic gastroparesis	1/138 (0.7%)	1
Erosive esophagitis	1/138 (0.7%)	1
GI bleed	3/138 (2.2%)	3
Gastric polyps	1/138 (0.7%)	1
Gastritis	1/138 (0.7%)	1
Gastrointestinal bleed	1/138 (0.7%)	1
Gastroparesis	2/138 (1.4%)	4
Ileitis	1/138 (0.7%)	1
Large intestine mass	1/138 (0.7%)	1
Peptic ulcer disease	1/138 (0.7%)	1
Rectal bleeding	1/138 (0.7%)	1
Vomiting	1/138 (0.7%)	1
General disorders
Chest pain	2/138 (1.4%)	2
Edema extremity upper	1/138 (0.7%)	1
Edema face	1/138 (0.7%)	1
Fever	1/138 (0.7%)	1
Multi organ failure	1/138 (0.7%)	1
Swelling arm	1/138 (0.7%)	1
Hepatobiliary disorders
Liver failure	1/138 (0.7%)	1
Infections and infestations
Appendicitis perforated	1/138 (0.7%)	1
Arteriovenous graft site cellulitis	1/138 (0.7%)	1
Arteriovenous graft site infection	9/138 (6.5%)	10
Bacterial endocarditis	1/138 (0.7%)	1
Bronchitis	1/138 (0.7%)	1
Cellulitis	1/138 (0.7%)	1
Cellulitis of hand	1/138 (0.7%)	1
Clostridium difficile colitis	1/138 (0.7%)	1
Community acquired pneumonia	1/138 (0.7%)	1
Diverticulitis	1/138 (0.7%)	1
Enterococcal sepsis	1/138 (0.7%)	1
Graft infection	1/138 (0.7%)	1
Hematoma infection	1/138 (0.7%)	1
Incision site infection	1/138 (0.7%)	1
Infected toe	1/138 (0.7%)	1
Peripheral gangrene	1/138 (0.7%)	1
Pneumonia	7/138 (5.1%)	7
Pyelonephritis	1/138 (0.7%)	1
Sepsis	4/138 (2.9%)	4
Septic shock	2/138 (1.4%)	2
Septicemia	2/138 (1.4%)	2
Staphylococcal bacteremia	1/138 (0.7%)	1
Staphylococcus aureus bacteremia	2/138 (1.4%)	2
Staphylococcus epidermidis infection	2/138 (1.4%)	2
Urinary tract infection	3/138 (2.2%)	3
Urinary tract infection pseudomonal	1/138 (0.7%)	1
Urosepsis	1/138 (0.7%)	1
Wound infection due to staphylococcus aureus	1/138 (0.7%)	1
Injury, poisoning and procedural complications
Anastomotic ulcer hemorrhage	1/138 (0.7%)	1
Arteriovenous graft site hemorrhage	1/138 (0.7%)	1
Bleeding of suture site	1/138 (0.7%)	1
Burst fracture	1/138 (0.7%)	1
Suture related complication	1/138 (0.7%)	1
Wrist fracture	1/138 (0.7%)	1
Investigations
Pulseless	1/138 (0.7%)	1
Metabolism and nutrition disorders
Acidosis	1/138 (0.7%)	1
Failure to thrive	1/138 (0.7%)	1
Hyperglycemia	1/138 (0.7%)	1
Hyperkalemia	2/138 (1.4%)	2
Hypoglycemia	2/138 (1.4%)	2
Hypokalemia	1/138 (0.7%)	1
Volume overload	2/138 (1.4%)	2
Musculoskeletal and connective tissue disorders
Hand pain	1/138 (0.7%)	1
Pain in extremity	1/138 (0.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/138 (0.7%)	1
Colonic neoplasm NOS	1/138 (0.7%)	1
Gastrointestinal stromal tumor	1/138 (0.7%)	1
Malignant neoplasm of pleura	1/138 (0.7%)	1
Multiple myeloma progression	1/138 (0.7%)	1
Non-small cell lung cancer	1/138 (0.7%)	1
Pancreatic cancer	1/138 (0.7%)	1
Prostate cancer	1/138 (0.7%)	1
Rectal adenocarcinoma	1/138 (0.7%)	1
Nervous system disorders
Anoxic encephalopathy	1/138 (0.7%)	1
CVA	3/138 (2.2%)	4
Carotid artery stenosis	1/138 (0.7%)	1
Encephalopathy acute	1/138 (0.7%)	1
Ischemic neuropathy	2/138 (1.4%)	2
Stroke	1/138 (0.7%)	1
Transient ischaemic attack	1/138 (0.7%)	1
Psychiatric disorders
Acute confusional state	1/138 (0.7%)	1
Mental status changes	4/138 (2.9%)	6
Renal and urinary disorders
End stage renal disease (ESRD)	2/138 (1.4%)	2
Renal failure	1/138 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	2/138 (1.4%)	2
Aspiration pneumonia	1/138 (0.7%)	1
Dyspnea	1/138 (0.7%)	1
Hypercapnic respiratory failure	1/138 (0.7%)	1
Pleural effusion	1/138 (0.7%)	1
Pulmonary embolism	1/138 (0.7%)	1
Pulmonary hypertension	1/138 (0.7%)	1
Pulmonary mass	1/138 (0.7%)	1
Respiratory distress	1/138 (0.7%)	1
Respiratory failure	4/138 (2.9%)	4
Shortness of breath	2/138 (1.4%)	3
Surgical and medical procedures
Renal transplant	2/138 (1.4%)	2
Vascular disorders
Critical limb ischemia	1/138 (0.7%)	1
Embolism	1/138 (0.7%)	1
Hypertension worsened	1/138 (0.7%)	1
Hypertensive crisis	1/138 (0.7%)	2
Hypertensive urgency	1/138 (0.7%)	1
Hypotension	5/138 (3.6%)	7
Peripheral ischemia	1/138 (0.7%)	1
Peripheral vascular disease	1/138 (0.7%)	1
Steal syndrome	15/138 (10.9%)	15
Uncontrolled hypertension	1/138 (0.7%)	1
Other (Not Including Serious) Adverse Events
	GORE® ACUSEAL Vascular Graft
	Affected / at Risk (%)	# Events
Total	0/138 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.