Trial Outcomes & Findings for Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (NCT NCT01173718)
NCT ID: NCT01173718
Last Updated: 2013-07-26
Results Overview
Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
138 participants
Primary outcome timeframe
6 Months
Results posted on
2013-07-26
Participant Flow
Participant milestones
| Measure |
GORE® ACUSEAL Vascular Graft
GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
|
|---|---|
|
Overall Study
STARTED
|
138
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
GORE® ACUSEAL Vascular Graft
GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
|
|---|---|
|
Overall Study
Death
|
17
|
|
Overall Study
Abandonment of study graft
|
27
|
Baseline Characteristics
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
Baseline characteristics by cohort
| Measure |
GORE® ACUSEAL Vascular Graft
n=138 Participants
GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
|
|---|---|
|
Age Continuous
|
63 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
138 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: All subjects with unknown cumulative patency status at the 6 month window were omitted from calculations
Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.
Outcome measures
| Measure |
GORE® ACUSEAL Vascular Graft
n=128 Participants
GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
|
|---|---|
|
Cumulative Patency at 6 Months
|
83.6 percentage of participants
Interval 76.0 to 89.5
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: All subjects with unknown bleeding status at the 6 month window were omitted from calculations
Percentage of subjects free from both major and minor bleeding events, assessed at 6-months
Outcome measures
| Measure |
GORE® ACUSEAL Vascular Graft
n=113 Participants
GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
|
|---|---|
|
Freedom From Bleeding at 6 Months
|
87.6 percentage of participants
Interval 80.1 to 93.1
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All subjects with unknown primary unassisted patency status at the 6 month window were omitted from calculations
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.
Outcome measures
| Measure |
GORE® ACUSEAL Vascular Graft
n=131 Participants
GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
|
|---|---|
|
Primary Unassisted Patency at 6 Months
|
45 percentage of participants
Interval 37.6 to 54.6
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All subjects with unknown time to event analysis (cumulative patency) status at the 6 month window were omitted from calculations
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.
Outcome measures
| Measure |
GORE® ACUSEAL Vascular Graft
n=128 Participants
GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
|
|---|---|
|
Time to Event Analysis (Cumulative Patency)
|
84.2 percentage of participants
Interval 76.8 to 89.4
|
SECONDARY outcome
Timeframe: Time of access placement to first cannulation, assessed up to one weekPopulation: All subjects with unknown time to first cannulation at the 6 month window were omitted from calculations
The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.
Outcome measures
| Measure |
GORE® ACUSEAL Vascular Graft
n=135 Participants
GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
|
|---|---|
|
Time to First Cannulation
Cannulated within 24 hours of procedure
|
22.2 percentage of grafts
|
|
Time to First Cannulation
Cannulated within 48 hours of procedure
|
35.6 percentage of grafts
|
|
Time to First Cannulation
Cannulated within 72 hours of procedure
|
40.0 percentage of grafts
|
|
Time to First Cannulation
Cannulated within 1 week of procedure
|
51.9 percentage of grafts
|
SECONDARY outcome
Timeframe: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123Population: All subjects with unknown time to potential central venous catheter removal at the 6 month window were omitted from calculations
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.
Outcome measures
| Measure |
GORE® ACUSEAL Vascular Graft
n=134 Participants
GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
|
|---|---|
|
Time to Potential Central Venous Catheter Removal
|
15.5 days
Interval 3.0 to 123.0
|
Adverse Events
GORE® ACUSEAL Vascular Graft
Serious events: 74 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GORE® ACUSEAL Vascular Graft
n=138 participants at risk
GORE® ACUSEAL Vascular Graft
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
6/138 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia aggravated
|
0.72%
1/138 • Number of events 1
|
|
Blood and lymphatic system disorders
Chronic thrombocytopenia
|
0.72%
1/138 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.72%
1/138 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
2/138 • Number of events 3
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
1.4%
2/138 • Number of events 2
|
|
Cardiac disorders
Atrial tachycardia
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
2.2%
3/138 • Number of events 3
|
|
Cardiac disorders
Cardiac arrhythmia
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Cardiogenic shock
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Chest pain - cardiac
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Congestive heart failure
|
2.9%
4/138 • Number of events 4
|
|
Cardiac disorders
Coronary artery disease
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Diastolic heart failure
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Non STEMI
|
2.9%
4/138 • Number of events 4
|
|
Cardiac disorders
Non-sustained ventricular tachycardia
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Pulseless electrical activity
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
STEMI
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
SVT
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Unstable angina
|
1.4%
2/138 • Number of events 2
|
|
Congenital, familial and genetic disorders
Polycystic kidney
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
Erosive esophagitis
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
GI bleed
|
2.2%
3/138 • Number of events 3
|
|
Gastrointestinal disorders
Gastric polyps
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
Gastroparesis
|
1.4%
2/138 • Number of events 4
|
|
Gastrointestinal disorders
Ileitis
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine mass
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
Peptic ulcer disease
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.72%
1/138 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.72%
1/138 • Number of events 1
|
|
General disorders
Chest pain
|
1.4%
2/138 • Number of events 2
|
|
General disorders
Edema extremity upper
|
0.72%
1/138 • Number of events 1
|
|
General disorders
Edema face
|
0.72%
1/138 • Number of events 1
|
|
General disorders
Fever
|
0.72%
1/138 • Number of events 1
|
|
General disorders
Multi organ failure
|
0.72%
1/138 • Number of events 1
|
|
General disorders
Swelling arm
|
0.72%
1/138 • Number of events 1
|
|
Hepatobiliary disorders
Liver failure
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Appendicitis perforated
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Arteriovenous graft site cellulitis
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Arteriovenous graft site infection
|
6.5%
9/138 • Number of events 10
|
|
Infections and infestations
Bacterial endocarditis
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Cellulitis of hand
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Community acquired pneumonia
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Enterococcal sepsis
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Graft infection
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Hematoma infection
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Incision site infection
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Infected toe
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Peripheral gangrene
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
5.1%
7/138 • Number of events 7
|
|
Infections and infestations
Pyelonephritis
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.9%
4/138 • Number of events 4
|
|
Infections and infestations
Septic shock
|
1.4%
2/138 • Number of events 2
|
|
Infections and infestations
Septicemia
|
1.4%
2/138 • Number of events 2
|
|
Infections and infestations
Staphylococcal bacteremia
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Staphylococcus aureus bacteremia
|
1.4%
2/138 • Number of events 2
|
|
Infections and infestations
Staphylococcus epidermidis infection
|
1.4%
2/138 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
2.2%
3/138 • Number of events 3
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Wound infection due to staphylococcus aureus
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer hemorrhage
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site hemorrhage
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bleeding of suture site
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Burst fracture
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.72%
1/138 • Number of events 1
|
|
Investigations
Pulseless
|
0.72%
1/138 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis
|
0.72%
1/138 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.72%
1/138 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.72%
1/138 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.4%
2/138 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.4%
2/138 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.72%
1/138 • Number of events 1
|
|
Metabolism and nutrition disorders
Volume overload
|
1.4%
2/138 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Hand pain
|
0.72%
1/138 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.72%
1/138 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.72%
1/138 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonic neoplasm NOS
|
0.72%
1/138 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumor
|
0.72%
1/138 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pleura
|
0.72%
1/138 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma progression
|
0.72%
1/138 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.72%
1/138 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
0.72%
1/138 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.72%
1/138 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.72%
1/138 • Number of events 1
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.72%
1/138 • Number of events 1
|
|
Nervous system disorders
CVA
|
2.2%
3/138 • Number of events 4
|
|
Nervous system disorders
Carotid artery stenosis
|
0.72%
1/138 • Number of events 1
|
|
Nervous system disorders
Encephalopathy acute
|
0.72%
1/138 • Number of events 1
|
|
Nervous system disorders
Ischemic neuropathy
|
1.4%
2/138 • Number of events 2
|
|
Nervous system disorders
Stroke
|
0.72%
1/138 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.72%
1/138 • Number of events 1
|
|
Psychiatric disorders
Acute confusional state
|
0.72%
1/138 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
2.9%
4/138 • Number of events 6
|
|
Renal and urinary disorders
End stage renal disease (ESRD)
|
1.4%
2/138 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
2/138 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnic respiratory failure
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.9%
4/138 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.4%
2/138 • Number of events 3
|
|
Surgical and medical procedures
Renal transplant
|
1.4%
2/138 • Number of events 2
|
|
Vascular disorders
Critical limb ischemia
|
0.72%
1/138 • Number of events 1
|
|
Vascular disorders
Embolism
|
0.72%
1/138 • Number of events 1
|
|
Vascular disorders
Hypertension worsened
|
0.72%
1/138 • Number of events 1
|
|
Vascular disorders
Hypertensive crisis
|
0.72%
1/138 • Number of events 2
|
|
Vascular disorders
Hypertensive urgency
|
0.72%
1/138 • Number of events 1
|
|
Vascular disorders
Hypotension
|
3.6%
5/138 • Number of events 7
|
|
Vascular disorders
Peripheral ischemia
|
0.72%
1/138 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disease
|
0.72%
1/138 • Number of events 1
|
|
Vascular disorders
Steal syndrome
|
10.9%
15/138 • Number of events 15
|
|
Vascular disorders
Uncontrolled hypertension
|
0.72%
1/138 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Debby Pfile, Clinical Research Associate
W. L. Gore & Associates
Phone: 623-234-5226
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER