Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel... | NCT00448708

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vascular Wrap and Graft	Experimental	Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access. The Vascular WrapTM Paclitaxel-Eluting Mesh is positioned on the vein and placed around the venous anastomosis to include both the toe and the heel of the anastomosis, and is sutured in place.	Device: Vascular Wrap Paclitaxel-Eluting Mesh Device: Lifespan® ePTFE Vascular Graft
Lifespan® ePTFE Vascular Graft	No Intervention	Lifespan® ePTFE Vascular Graft Only: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access.	Device: Lifespan® ePTFE Vascular Graft

Name	Type	Description	Arm Group Labels	Other Names
Vascular Wrap Paclitaxel-Eluting Mesh	Device	0.9 µg/mm^2 paclitaxel	Vascular Wrap and Graft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time-to-loss of Target Site Primary Patency	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.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	adverse 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.	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be ≥ 18 years of age;
if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0);
be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity;
have an outflow vein of greater than or equal to 3 mm in diameter;
be able to effectively communicate with study personnel;
be considered by the physician to be available for subsequent visits;
be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration;
allow representatives of the sponsor, designated CRO, Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records;
sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures;
must agree to participate in protocol 014-VWAV07, a safety study to run consecutively for an additional 4 years or until Post-Market Approval (PMA), whichever is longer; and
have the Lifespan® ePTFE Vascular Graft successfully implanted.

Exclusion Criteria:

pregnant, breast-feeding, or female of childbearing potential who do not agree to remain abstinent or to use a contraceptive method during the study period. Non-childbearing potential is defined as either post-menopausal (amenorrheic for at least 1 year) or surgically sterile. Surgically sterile is defined as tubal ligation or the absence of the uterus and/or ovaries;
male of childbearing potential, who does not agree to remain abstinent or to use contraception to prevent fathering a child during the course of the study. Non-childbearing potential is defined as vasectomy or bilateral orchiectomy;
a central venous stenosis on the ipsilateral side is documented;
a hypercoagulable state is documented;
life expectancy is less than one year;
an organ transplant is expected within 6 months of test or control product (study products) placement;
hypersensitivity to any component of the study products or procedural materials or medications is known;
concurrently involved in another investigational study;
a study product being investigated by others has been received within 30 days prior to randomization in this trial;
the study product being studied in this trial has previously been received;
uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening;
currently receiving chemotherapy or radiation therapy; or
placement of a new end-to-end arteriovenous anastomosis graft is required.

Name	Affiliation	Role
Rui Avelar, MD	Angiotech Pharmaceuticals	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Center		Birmingham	Alabama	35213	United States
Ladenheim, Inc.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Vascular Wrap and Graft	Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
FG001	Lifespan® ePTFE Vascular Graft	Lifespan® ePTFE Vascular Graft Only

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064± 13.72 BG00161± 15.58 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00061 BG00165 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000112 BG001110 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time-to-loss of Target Site Primary Patency

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.

Posted

Median

95% Confidence Interval

days

1 year

ID	Title	Description
OG000	Vascular Wrap and Graft	Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
OG001	Lifespan® ePTFE Vascular Graft	Lifespan® ePTFE Vascular Graft Only

Units	Counts
Participants	OG000110 OG001112

Title

Denominators

Categories

Title	Measurements
	OG000130(87 to 190) OG001159(86 to 227)

Secondary

Adverse Events

adverse 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.

Posted

Number

participants

1 year

ID	Title	Description
OG000	Vascular Wrap and Graft	Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
OG001	Lifespan® ePTFE Vascular Graft	Lifespan® ePTFE Vascular Graft Only

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk
Cardiac arrest	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0003 events3 affected110 at risk EG0012 events2 affected112 at risk
Cardiac failure	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Bacteraemia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Sepsis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0001 events1 affected110 at risk EG0012 events2 affected112 at risk
Septic shock	Infections and infestations	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk
Dementia Alzhemier's type	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Haemorrhage stroke	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0001 events1 affected110 at risk EG0010 events0 affected112 at risk
Renal failure	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0003 events3 affected110 at risk EG0011 events1 affected112 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0001 events1 affected110 at risk EG0011 events1 affected112 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0011 events1 affected112 at risk
Hypotension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0000 events0 affected110 at risk EG0012 events2 affected112 at risk
Death unknown cause	General disorders	MedDRA (9.1)	Systematic Assessment	This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.	EG0002 events2 affected110 at risk EG0011 events1 affected112 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Graft infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG00036 events32 affected110 at risk EG00114 events13 affected112 at risk
Anemia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG00015 events15 affected110 at risk EG0016 events6 affected112 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG00012 events12 affected110 at risk EG0015 events5 affected112 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0006 events6 affected110 at risk EG0017 events7 affected112 at risk
Tachycardia	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0007 events7 affected110 at risk EG0014 events4 affected112 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0005 events5 affected110 at risk EG0018 events8 affected112 at risk
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG00015 events15 affected110 at risk EG0017 events7 affected112 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG00014 events14 affected110 at risk EG00112 events12 affected112 at risk
Nausea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG00030 events30 affected110 at risk EG00118 events18 affected112 at risk
Vomiting	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG00017 events17 affected110 at risk EG0019 events9 affected112 at risk
Asthenia	General disorders	MedDRA (9.1)	Systematic Assessment	EG00010 events10 affected110 at risk EG0018 events8 affected112 at risk
Catheter related complication	General disorders	MedDRA (9.1)	Systematic Assessment	EG0004 events4 affected110 at risk EG0016 events6 affected112 at risk
Catheter site hemorrhage	General disorders	MedDRA (9.1)	Systematic Assessment	EG0002 events2 affected110 at risk EG0017 events7 affected112 at risk
Chest pain	General disorders	MedDRA (9.1)	Systematic Assessment	EG00014 events14 affected110 at risk EG00110 events10 affected112 at risk
Generalized oedema	General disorders	MedDRA (9.1)	Systematic Assessment	EG0008 events8 affected110 at risk EG0012 events2 affected112 at risk
Oedema peripheral	General disorders	MedDRA (9.1)	Systematic Assessment	EG00026 events26 affected110 at risk EG00121 events21 affected112 at risk
Pyrexia	General disorders	MedDRA (9.1)	Systematic Assessment	EG00017 events17 affected110 at risk EG00112 events12 affected112 at risk
Bacteraemia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0008 events8 affected110 at risk EG0010 events0 affected112 at risk
Catheter related infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0005 events5 affected110 at risk EG0016 events6 affected112 at risk
Cellulitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG00012 events12 affected110 at risk EG0017 events7 affected112 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG00010 events10 affected110 at risk EG00113 events13 affected112 at risk
Sepsis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG00013 events13 affected110 at risk EG00110 events10 affected112 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG00012 events12 affected110 at risk EG0018 events8 affected112 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0004 events4 affected110 at risk EG0016 events6 affected112 at risk
Graft hemorrhage	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG00010 events10 affected110 at risk EG0014 events4 affected112 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG00041 events41 affected110 at risk EG00151 events51 affected112 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG00010 events10 affected110 at risk EG0010 events0 affected112 at risk
Breath sounds abnormal	Investigations	MedDRA (9.1)	Systematic Assessment	EG00012 events12 affected110 at risk EG00112 events12 affected112 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0006 events6 affected110 at risk EG0011 events1 affected112 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0004 events4 affected110 at risk EG0018 events8 affected112 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0007 events7 affected110 at risk EG00114 events14 affected112 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG00011 events11 affected110 at risk EG0017 events7 affected112 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0005 events5 affected110 at risk EG0016 events6 affected112 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0007 events7 affected110 at risk EG0018 events8 affected112 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG00026 events26 affected110 at risk EG00124 events24 affected112 at risk
Dizziness	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG00010 events10 affected110 at risk EG0016 events6 affected112 at risk
Headache	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG00012 events12 affected110 at risk EG00113 events13 affected112 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0007 events7 affected110 at risk EG0018 events8 affected112 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0007 events7 affected110 at risk EG0012 events2 affected112 at risk
Anxiety	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0006 events6 affected110 at risk EG0012 events2 affected112 at risk
Insomnia	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0009 events9 affected110 at risk EG0019 events9 affected112 at risk
Mental status changes	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0007 events7 affected110 at risk EG0014 events4 affected112 at risk
Anuria	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0006 events6 affected110 at risk EG0012 events2 affected112 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0005 events5 affected110 at risk EG0017 events7 affected112 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG00012 events12 affected110 at risk EG00110 events10 affected112 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0006 events6 affected110 at risk EG0013 events3 affected112 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0009 events9 affected110 at risk EG0017 events7 affected112 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0007 events7 affected110 at risk EG0019 events9 affected112 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG00012 events12 affected110 at risk EG0013 events3 affected112 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG00011 events11 affected110 at risk EG0018 events8 affected112 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0005 events5 affected110 at risk EG0016 events6 affected112 at risk
Hematoma	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG00010 events10 affected110 at risk EG0018 events8 affected112 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG00013 events13 affected110 at risk EG00115 events15 affected112 at risk
Hypotension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG00019 events19 affected110 at risk EG00123 events23 affected112 at risk
Steal syndrome	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0008 events8 affected110 at risk EG0019 events9 affected112 at risk
Thrombosis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG00011 events11 affected110 at risk EG00110 events10 affected112 at risk
Venous stenosis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG00011 events11 affected110 at risk EG00110 events10 affected112 at risk

ID	Term
D007674	Kidney Diseases
D007676	Kidney Failure, Chronic

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Vascular Wrap and Graft	Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
BG001	Lifespan® ePTFE Vascular Graft	Lifespan® ePTFE Vascular Graft Only
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vascular Wrap and Graft	Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh			17	110	106	110
EG001	Lifespan® ePTFE Vascular Graft	Lifespan® ePTFE Vascular Graft Only			21	112	110	112