Study Comparing Lutonix AV Drug Coated Balloon vs Standar... | NCT02440022

NCT02440022

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lutonix DCB	Experimental	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.	Combination Product: Lutonix DCB Procedure: Percutaneous Transluminal Angiography
Standard Balloon Angioplasty Catheter	Active Comparator	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.	Device: Standard Balloon Angioplasty Catheter Procedure: Percutaneous Transluminal Angiography

Name	Type	Description	Arm Group Labels	Other Names
Lutonix DCB	Combination Product		Lutonix DCB
Standard Balloon Angioplasty Catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure	Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.	6 months post index procedure
Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.	The primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit (CEC adjudicated).	30 Days Post Index Procedure

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months	Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.	3, 9, 12, 18, and 24 Months Post Index Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥21 years;
The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF);
Arteriovenous fistula located in the arm;
Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions;
Venous stenosis of an AV fistula with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.;
Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon;
Intended target lesion.

Exclusion Criteria:

Women who are pregnant, lactating, or planning on becoming pregnant during the study;
Hemodialysis access is located in the leg;
Subject has more than two lesions in the access circuit;
Subject has a secondary non-target lesion that cannot be successfully treated;
Target lesion is located central to the axillosubclavian junction;
The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);
A thrombosed access;
Surgical revision of the access site planned;
Recent prior surgical interventions of the access site;
Other planned treatment during the index procedure;
Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;
Known contraindication (including allergic reaction) or sensitivity to paclitaxel.
Subjects who are taking immunosuppressive therapy or are routinely taking

≥10mg of prednisone per day;
Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation;
Subject has a life expectancy <12 months;
Anticipated for a kidney transplant;
Anticipated conversion to peritoneal dialysis;
Subject has a stent located in the target or secondary non target lesion;
Subject has an infected AV access or systemic infection;
Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.

Contacts/Locations Module

Name	Affiliation	Role
Scott Trerotola, MD	University of Pennsylvania	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Board of Trustees of The University of Alabama for the University of Alabama at Birmingham		Birmingham	Alabama	35233	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30042225	Derived	Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF; Lutonix AV Clinical Trial Investigators. Drug Coated Balloon Angioplasty in Failing AV Fistulas: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2018 Aug 7;13(8):1215-1224. doi: 10.2215/CJN.14231217. Epub 2018 Jul 24.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 30, 2015

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
BG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00063.6± 14.46 BG00161± 13.36 BG00262.3± 13.95

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00054 BG00159 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00021 BG00128 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000141 BG001144 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

Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure

Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.

Posted

Number

95% Confidence Interval

Percentage of Participants

6 months post index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Units	Counts
Participants	OG000141 OG001144

Title

Denominators

Categories

Title	Measurements
	OG00071.4(62.7 to 78.4) OG00163(54.4 to 70.4)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Kaplan-Meier		0.0562														Superiority

Primary

Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.

The primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit (CEC adjudicated).

Posted

Count of Participants

Participants

30 Days Post Index Procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months

Posted

Number

95% Confidence Interval

Percentage of Participants

3, 9, 12, 18, and 24 Months Post Index Procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Percentage of Participants With Device, Procedural and Clinical Success

Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure.
Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs).
Clinical Success: The resumption of dialysis for at least one session after the index procedure.

Posted

Number

Percentage of participants

Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

Index access site abandonment refers to an abandonment due to either receiving a kidney transplant, converting to Peritoneal Dialysis, or a new access site being created.

Posted

Count of Participants

Participants

3, 6, 9, 12, 18 and 24 Months Post Index Procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

Posted

Number

Interventions

3, 6, 9, 12, 18 and 24 Months Post Index Procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated)

Events adjudicated as 'definitely related' and 'possibly related' by the CEC were combined in all analyses and are displayed as 'related' in this report.

CEC adjudicated.

Posted

Count of Participants

Participants

1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure

The (n) analyzed depended on the number of participants for which data was available at the time of analysis.

Posted

Count of Participants

Participants

6 Months Post Index Procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

Posted

Number

Interventions

3, 6, 9, 12, 18, and 24 Months Post Index Procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Secondary

Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

Posted

Number

Events

1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

ID	Title	Description
OG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
OG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	33	141	115	141	97	141
EG001	Standard Balloon Angioplasty Catheter	Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	26	144	123	144	114	144

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Arrhythmia	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Cardiac arrest	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0006 affected141 at risk EG0016 affected144 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Coronary artery disease	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0013 affected144 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0011 affected144 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Cardiac death	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Death	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected141 at risk EG0011 affected144 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Haematoma infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Pneumonia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0011 affected144 at risk
Septic shock	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected141 at risk EG0010 affected144 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0006 affected141 at risk EG0016 affected144 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0012 affected144 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG00094 affected141 at risk EG001110 affected144 at risk
Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG00013 affected141 at risk EG00117 affected144 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected141 at risk EG0010 affected144 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0011 affected144 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0013 affected144 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Oropharyngeal cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Brain Injury	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0011 affected144 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0007 affected141 at risk EG0015 affected144 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected141 at risk EG0010 affected144 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0011 affected144 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0011 affected144 at risk
Arteriosclerosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Brachiocephalic vein stenosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected141 at risk EG0014 affected144 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected141 at risk EG0011 affected144 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Steal syndrome	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected141 at risk EG0011 affected144 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected141 at risk EG0010 affected144 at risk
Venous occlusion	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0009 affected141 at risk EG00114 affected144 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiogenic shock	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected144 at risk
Myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected144 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected144 at risk
Haematoma infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected144 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected144 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0006 events6 affected141 at risk EG0016 events6 affected144 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected144 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG00094 events94 affected141 at risk EG001110 events110 affected144 at risk
Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected144 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected144 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG00013 events13 affected141 at risk EG00117 events17 affected144 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected144 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected144 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected144 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected144 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected144 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected144 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected144 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected144 at risk
Brachiocephalic vein stenosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 events2 affected141 at risk EG0014 events4 affected144 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected144 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected144 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected144 at risk
Steal syndrome	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected144 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected144 at risk
Vascular calcification	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected144 at risk
Vasospasm	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected144 at risk
Venous occlusion	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0009 events9 affected141 at risk EG00114 events14 affected144 at risk

ID	Term
D001164	Arteriovenous Fistula

Ancestor Terms

ID	Term
D001165	Arteriovenous Malformations
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D016157	Vascular Fistula
D014652	Vascular Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D005402	Fistula
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Units	Counts
Participants	OG000141 OG001144

Units	Counts
Participants	OG000141 OG001144

Units	Counts
Participants	OG000141 OG001144