Trial Outcomes & Findings for Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access (NCT NCT00448708)
NCT ID: NCT00448708
Last Updated: 2011-11-17
Results Overview
Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the "time-to-loss of primary patency." Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
222 participants
Primary outcome timeframe
1 year
Results posted on
2011-11-17
Participant Flow
Participant milestones
| Measure |
Vascular Wrap and Graft
Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
|
Lifespan® ePTFE Vascular Graft
Lifespan® ePTFE Vascular Graft Only
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
110
|
|
Overall Study
COMPLETED
|
77
|
79
|
|
Overall Study
NOT COMPLETED
|
35
|
31
|
Reasons for withdrawal
| Measure |
Vascular Wrap and Graft
Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
|
Lifespan® ePTFE Vascular Graft
Lifespan® ePTFE Vascular Graft Only
|
|---|---|---|
|
Overall Study
Death
|
21
|
17
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
8
|
|
Overall Study
not listed
|
0
|
2
|
Baseline Characteristics
Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
Baseline characteristics by cohort
| Measure |
Vascular Wrap and Graft
n=112 Participants
Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
|
Lifespan® ePTFE Vascular Graft
n=110 Participants
Lifespan® ePTFE Vascular Graft Only
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
116 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
58 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
|
Age Continuous
|
64 years
STANDARD_DEVIATION 13.72 • n=93 Participants
|
61 years
STANDARD_DEVIATION 15.58 • n=4 Participants
|
63 years
STANDARD_DEVIATION 14.70 • n=27 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
126 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
96 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=93 Participants
|
110 participants
n=4 Participants
|
222 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 yearSubjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the "time-to-loss of primary patency." Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol.
Outcome measures
| Measure |
Vascular Wrap and Graft
n=110 Participants
Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
|
Lifespan® ePTFE Vascular Graft
n=112 Participants
Lifespan® ePTFE Vascular Graft Only
|
|---|---|---|
|
Time-to-loss of Target Site Primary Patency
|
130 days
Interval 87.0 to 190.0
|
159 days
Interval 86.0 to 227.0
|
SECONDARY outcome
Timeframe: 1 yearadverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review.
Outcome measures
| Measure |
Vascular Wrap and Graft
n=110 Participants
Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
|
Lifespan® ePTFE Vascular Graft
n=112 Participants
Lifespan® ePTFE Vascular Graft Only
|
|---|---|---|
|
Adverse Events
Total Number of Adverse Events
|
1451 participants
|
1164 participants
|
|
Adverse Events
Serious Adverse Events (deaths only)
|
17 participants
|
21 participants
|
Adverse Events
Vascular Wrap and Graft
Serious events: 17 serious events
Other events: 106 other events
Deaths: 0 deaths
Lifespan® ePTFE Vascular Graft
Serious events: 21 serious events
Other events: 110 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vascular Wrap and Graft
n=110 participants at risk
Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
|
Lifespan® ePTFE Vascular Graft
n=112 participants at risk
Lifespan® ePTFE Vascular Graft Only
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.91%
1/110 • Number of events 1 • 1 year
|
0.00%
0/112 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
2.7%
3/110 • Number of events 3 • 1 year
|
1.8%
2/112 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.91%
1/110 • Number of events 1 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacteraemia
|
0.91%
1/110 • Number of events 1 • 1 year
|
0.00%
0/112 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
0.91%
1/110 • Number of events 1 • 1 year
|
1.8%
2/112 • Number of events 2 • 1 year
|
|
Infections and infestations
Septic shock
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Cachexia
|
0.91%
1/110 • Number of events 1 • 1 year
|
0.00%
0/112 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.91%
1/110 • Number of events 1 • 1 year
|
0.00%
0/112 • 1 year
|
|
Nervous system disorders
Dementia Alzhemier's type
|
0.91%
1/110 • Number of events 1 • 1 year
|
0.00%
0/112 • 1 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhage stroke
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ischaemic stroke
|
0.91%
1/110 • Number of events 1 • 1 year
|
0.00%
0/112 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
2.7%
3/110 • Number of events 3 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure chronic
|
0.91%
1/110 • Number of events 1 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/110 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/110 • 1 year
|
1.8%
2/112 • Number of events 2 • 1 year
|
|
General disorders
Death unknown cause
|
1.8%
2/110 • Number of events 2 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Vascular Wrap and Graft
n=110 participants at risk
Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
|
Lifespan® ePTFE Vascular Graft
n=112 participants at risk
Lifespan® ePTFE Vascular Graft Only
|
|---|---|---|
|
Infections and infestations
Graft infection
|
29.1%
32/110 • Number of events 36 • 1 year
|
11.6%
13/112 • Number of events 14 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
13.6%
15/110 • Number of events 15 • 1 year
|
5.4%
6/112 • Number of events 6 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.9%
12/110 • Number of events 12 • 1 year
|
4.5%
5/112 • Number of events 5 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
5.5%
6/110 • Number of events 6 • 1 year
|
6.2%
7/112 • Number of events 7 • 1 year
|
|
Cardiac disorders
Tachycardia
|
6.4%
7/110 • Number of events 7 • 1 year
|
3.6%
4/112 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
5/110 • Number of events 5 • 1 year
|
7.1%
8/112 • Number of events 8 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
13.6%
15/110 • Number of events 15 • 1 year
|
6.2%
7/112 • Number of events 7 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
12.7%
14/110 • Number of events 14 • 1 year
|
10.7%
12/112 • Number of events 12 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
27.3%
30/110 • Number of events 30 • 1 year
|
16.1%
18/112 • Number of events 18 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
15.5%
17/110 • Number of events 17 • 1 year
|
8.0%
9/112 • Number of events 9 • 1 year
|
|
General disorders
Asthenia
|
9.1%
10/110 • Number of events 10 • 1 year
|
7.1%
8/112 • Number of events 8 • 1 year
|
|
General disorders
Catheter related complication
|
3.6%
4/110 • Number of events 4 • 1 year
|
5.4%
6/112 • Number of events 6 • 1 year
|
|
General disorders
Catheter site hemorrhage
|
1.8%
2/110 • Number of events 2 • 1 year
|
6.2%
7/112 • Number of events 7 • 1 year
|
|
General disorders
Chest pain
|
12.7%
14/110 • Number of events 14 • 1 year
|
8.9%
10/112 • Number of events 10 • 1 year
|
|
General disorders
Generalized oedema
|
7.3%
8/110 • Number of events 8 • 1 year
|
1.8%
2/112 • Number of events 2 • 1 year
|
|
General disorders
Oedema peripheral
|
23.6%
26/110 • Number of events 26 • 1 year
|
18.8%
21/112 • Number of events 21 • 1 year
|
|
General disorders
Pyrexia
|
15.5%
17/110 • Number of events 17 • 1 year
|
10.7%
12/112 • Number of events 12 • 1 year
|
|
Infections and infestations
Bacteraemia
|
7.3%
8/110 • Number of events 8 • 1 year
|
0.00%
0/112 • 1 year
|
|
Infections and infestations
Catheter related infection
|
4.5%
5/110 • Number of events 5 • 1 year
|
5.4%
6/112 • Number of events 6 • 1 year
|
|
Infections and infestations
Cellulitis
|
10.9%
12/110 • Number of events 12 • 1 year
|
6.2%
7/112 • Number of events 7 • 1 year
|
|
Infections and infestations
Pneumonia
|
9.1%
10/110 • Number of events 10 • 1 year
|
11.6%
13/112 • Number of events 13 • 1 year
|
|
Infections and infestations
Sepsis
|
11.8%
13/110 • Number of events 13 • 1 year
|
8.9%
10/112 • Number of events 10 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
10.9%
12/110 • Number of events 12 • 1 year
|
7.1%
8/112 • Number of events 8 • 1 year
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.6%
4/110 • Number of events 4 • 1 year
|
5.4%
6/112 • Number of events 6 • 1 year
|
|
Injury, poisoning and procedural complications
Graft hemorrhage
|
9.1%
10/110 • Number of events 10 • 1 year
|
3.6%
4/112 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
37.3%
41/110 • Number of events 41 • 1 year
|
45.5%
51/112 • Number of events 51 • 1 year
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
9.1%
10/110 • Number of events 10 • 1 year
|
0.00%
0/112 • 1 year
|
|
Investigations
Breath sounds abnormal
|
10.9%
12/110 • Number of events 12 • 1 year
|
10.7%
12/112 • Number of events 12 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
5.5%
6/110 • Number of events 6 • 1 year
|
0.89%
1/112 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.6%
4/110 • Number of events 4 • 1 year
|
7.1%
8/112 • Number of events 8 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.4%
7/110 • Number of events 7 • 1 year
|
12.5%
14/112 • Number of events 14 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
11/110 • Number of events 11 • 1 year
|
6.2%
7/112 • Number of events 7 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
5/110 • Number of events 5 • 1 year
|
5.4%
6/112 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
7/110 • Number of events 7 • 1 year
|
7.1%
8/112 • Number of events 8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.6%
26/110 • Number of events 26 • 1 year
|
21.4%
24/112 • Number of events 24 • 1 year
|
|
Nervous system disorders
Dizziness
|
9.1%
10/110 • Number of events 10 • 1 year
|
5.4%
6/112 • Number of events 6 • 1 year
|
|
Nervous system disorders
Headache
|
10.9%
12/110 • Number of events 12 • 1 year
|
11.6%
13/112 • Number of events 13 • 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
6.4%
7/110 • Number of events 7 • 1 year
|
7.1%
8/112 • Number of events 8 • 1 year
|
|
Nervous system disorders
Unresponsive to stimuli
|
6.4%
7/110 • Number of events 7 • 1 year
|
1.8%
2/112 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Anxiety
|
5.5%
6/110 • Number of events 6 • 1 year
|
1.8%
2/112 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Insomnia
|
8.2%
9/110 • Number of events 9 • 1 year
|
8.0%
9/112 • Number of events 9 • 1 year
|
|
Psychiatric disorders
Mental status changes
|
6.4%
7/110 • Number of events 7 • 1 year
|
3.6%
4/112 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Anuria
|
5.5%
6/110 • Number of events 6 • 1 year
|
1.8%
2/112 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
5/110 • Number of events 5 • 1 year
|
6.2%
7/112 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.9%
12/110 • Number of events 12 • 1 year
|
8.9%
10/112 • Number of events 10 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
5.5%
6/110 • Number of events 6 • 1 year
|
2.7%
3/112 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
8.2%
9/110 • Number of events 9 • 1 year
|
6.2%
7/112 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.4%
7/110 • Number of events 7 • 1 year
|
8.0%
9/112 • Number of events 9 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.9%
12/110 • Number of events 12 • 1 year
|
2.7%
3/112 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
10.0%
11/110 • Number of events 11 • 1 year
|
7.1%
8/112 • Number of events 8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.5%
5/110 • Number of events 5 • 1 year
|
5.4%
6/112 • Number of events 6 • 1 year
|
|
Vascular disorders
Hematoma
|
9.1%
10/110 • Number of events 10 • 1 year
|
7.1%
8/112 • Number of events 8 • 1 year
|
|
Vascular disorders
Hypertension
|
11.8%
13/110 • Number of events 13 • 1 year
|
13.4%
15/112 • Number of events 15 • 1 year
|
|
Vascular disorders
Hypotension
|
17.3%
19/110 • Number of events 19 • 1 year
|
20.5%
23/112 • Number of events 23 • 1 year
|
|
Vascular disorders
Steal syndrome
|
7.3%
8/110 • Number of events 8 • 1 year
|
8.0%
9/112 • Number of events 9 • 1 year
|
|
Vascular disorders
Thrombosis
|
10.0%
11/110 • Number of events 11 • 1 year
|
8.9%
10/112 • Number of events 10 • 1 year
|
|
Vascular disorders
Venous stenosis
|
10.0%
11/110 • Number of events 11 • 1 year
|
8.9%
10/112 • Number of events 10 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place