The Merit WRAPSODY AV Access Efficacy Study (WAVE) | NCT04540302

Label	Type	Description	Intervention Names
AVF Peripheral study treatment group	Experimental	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft	Device: Merit WRAPSODY Endovascular Stent Graft
AVF Peripheral control group	Other	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)	Device: PTA
AVG Anastomosis	Experimental	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft	Device: Merit WRAPSODY Endovascular Stent Graft

Name	Type	Description	Arm Group Labels	Other Names
Merit WRAPSODY Endovascular Stent Graft	Device	Target lesion treated with stent graft placement	AVF Peripheral study treatment group AVG Anastomosis

Measure	Description	Time Frame
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)	Percentage of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.	30 days
Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)	Percentage of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.	6 months

Measure	Description	Time Frame
Subjects With Target Lesion Primary Patency	Percentage of subjects with Target Lesion Primary Patency (TLPP) at 12 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.

Name	Affiliation	Role
Mahmood K Razavi, MD	St. Joseph's Hospital, Orange, CA	Principal Investigator
Robert Jones, MD	The Queen Elizabeth Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Kidney institute (SKI) Vascular Center		Tempe	Arizona	85281	United States
Pima Heart and Vascular

ID	Title	Description
FG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
FG001	AVF Peripheral Control Group

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	Mar 30, 2023

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

Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)

Percentage of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.

Denominators include all subjects who have the indicated event or who have adequate follow-up

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants	OG000119 OG001121 OG002109

Title

Denominators

Categories

Title	Measurements
	OG000115 OG001115 OG002104

Primary

Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)

Percentage of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.

Denominators include all subjects who have the indicated event or who have adequate follow-up

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Secondary

Subjects With Target Lesion Primary Patency

Percentage of subjects with Target Lesion Primary Patency (TLPP) at 12 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.

Denominators include all subjects who have the indicated event or who have adequate follow-up

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Secondary

Subjects With Target Lesion Primary Patency

Percentage of subjects with Target Lesion Primary Patency (TLPP) at 24 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.

Denominators include all subjects who have the indicated event or who have adequate follow-up

Posted

Count of Participants

Participants

24 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Secondary

Subjects With Assisted Target Lesion Primary Patency (aTLPP)

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 6 months.

aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.

Assisted Target Lesion Primary Patency (aTLPP) was analyzed using the Kaplan-Meier method. The reported percentages represent the Kaplan-Meier estimated probability of remaining free from loss of assisted target lesion primary patency at the specified time point. These estimates account for censoring and are not simple proportions of participants experiencing the event.

Posted

Number

KM estimate (%)

6 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis

Secondary

Subjects With Assisted Target Lesion Primary Patency (aTLPP)

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 12 months.

Posted

Number

KM estimate (%)

12 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis

Secondary

Subjects With Assisted Target Lesion Primary Patency (aTLPP)

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 24 months.

Posted

Number

KM estimate (%)

24 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis

Secondary

Subjects With Access Circuit Primary Patency (ACPP)

Denominators include all subjects who have the indicated event or who have adequate follow-up

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Subjects With Access Circuit Primary Patency (ACPP)

Denominators include all subjects who have the indicated event or who have adequate follow-up

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Subjects With Access Circuit Primary Patency (ACPP)

Denominators include all subjects who have the indicated event or who have adequate follow-up

Posted

Count of Participants

Participants

24 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Subjects With Post-Procedure Secondary Patency

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 6 months.

Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.

Post-Procedure Secondary Patency was analyzed using the Kaplan-Meier method. The reported percentages represent the Kaplan-Meier estimated probability of remaining free from loss of Post-Procedure Secondary Patency at the specified time point. These estimates account for censoring and are not simple proportions of participants experiencing the event.

Posted

Number

KM estimate (%)

6 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis

Secondary

Subjects With Post-Procedure Secondary Patency

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 12 months.

Posted

Number

KM estimate (%)

12 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis

Secondary

Subjects With Post-Procedure Secondary Patency

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 24 months.

Posted

Number

KM estimate (%)

24 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis

Secondary

Rates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at index procedure

Posted

Count of Participants

Participants

Index procedure

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Rates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at index procedure

Posted

Count of Participants

Participants

Index procedure

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Rates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at 30 days

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Rates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at 30 days

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Rates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at 6 months

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Rates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at 6 months

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Rates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at 12 months

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Rates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at 12 months

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Rates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at 24 months

Posted

Count of Participants

Participants

24 Months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Secondary

Rates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at 24 months

Posted

Count of Participants

Participants

24 Months

ID	Title	Description
OG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
OG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
OG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abrupt vessel closure of treated segment (abrupt occlusion)	Vascular disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0011 events1 affected123 at risk EG0020 events0 affected112 at risk
Access (puncture) site complication requiring surgery or transfusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected122 at risk EG0011 events1 affected123 at risk EG0020 events0 affected112 at risk
Allergic reaction (medication, contrast media, device, etc.)	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected122 at risk EG0010 events0 affected123 at risk EG0021 events1 affected112 at risk
Amputation	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected122 at risk EG0011 events1 affected123 at risk EG0027 events5 affected112 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events1 affected122 at risk EG0011 events1 affected123 at risk EG0024 events3 affected112 at risk
Aneurysm	Vascular disorders	Systematic Assessment	EG0003 events3 affected122 at risk EG0011 events1 affected123 at risk EG0021 events1 affected112 at risk
Angina	Cardiac disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0011 events1 affected123 at risk EG0023 events3 affected112 at risk
Arterial bypass surgery	Cardiac disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0011 events1 affected123 at risk EG0021 events1 affected112 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0004 events4 affected122 at risk EG0012 events1 affected123 at risk EG0023 events3 affected112 at risk
Bacteremia or septicemia	Infections and infestations	Systematic Assessment	EG0005 events5 affected122 at risk EG0012 events2 affected123 at risk EG0029 events8 affected112 at risk
Bleeding complication	Vascular disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0015 events5 affected123 at risk EG0022 events2 affected112 at risk
Bronchitis or bronchiolitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0010 events0 affected123 at risk EG0020 events0 affected112 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG00011 events11 affected122 at risk EG00110 events10 affected123 at risk EG0023 events3 affected112 at risk
Cardiac arrhythmia	Cardiac disorders	Systematic Assessment	EG0002 events1 affected122 at risk EG0016 events5 affected123 at risk EG0023 events3 affected112 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0011 events1 affected123 at risk EG0020 events0 affected112 at risk
Chronic Obstructive Pulmonary Disease (COPD)	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events1 affected122 at risk EG0010 events0 affected123 at risk EG0020 events0 affected112 at risk
Congestive Heart Failure (CHF)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected122 at risk EG0013 events3 affected123 at risk EG0022 events2 affected112 at risk
Coronary Artery Disease (CAD)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected122 at risk EG0013 events2 affected123 at risk EG0021 events1 affected112 at risk
Edema, significant	Cardiac disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0011 events1 affected123 at risk EG0021 events1 affected112 at risk
Fever (> 38.3ºC/101ºF)	General disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0010 events0 affected123 at risk EG0023 events2 affected112 at risk
Gastro-intestinal bleeding	Gastrointestinal disorders	Systematic Assessment	EG0004 events3 affected122 at risk EG0013 events2 affected123 at risk EG0029 events6 affected112 at risk
Hemorrhage, with or without transfusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected122 at risk EG0011 events1 affected123 at risk EG0020 events0 affected112 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected122 at risk EG0015 events5 affected123 at risk EG0020 events0 affected112 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0013 events3 affected123 at risk EG0026 events4 affected112 at risk
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0010 events0 affected123 at risk EG0020 events0 affected112 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0006 events6 affected122 at risk EG0012 events1 affected123 at risk EG0024 events3 affected112 at risk
Infection, access circuit, stent graft	Infections and infestations	Systematic Assessment	EG0000 events0 affected122 at risk EG0011 events1 affected123 at risk EG0023 events3 affected112 at risk
Infection, localized	Infections and infestations	Systematic Assessment	EG0004 events4 affected122 at risk EG0017 events5 affected123 at risk EG00210 events8 affected112 at risk
Ischemia, limb, (non-cardiac)	Vascular disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0012 events2 affected123 at risk EG0020 events0 affected112 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0003 events2 affected122 at risk EG0017 events7 affected123 at risk EG0023 events2 affected112 at risk
Myocardial ischemia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0010 events0 affected123 at risk EG0020 events0 affected112 at risk
Necrosis	General disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0010 events0 affected123 at risk EG0022 events2 affected112 at risk
Peripheral ischemia	Vascular disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0011 events1 affected123 at risk EG0022 events2 affected112 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 events6 affected122 at risk EG0019 events8 affected123 at risk EG0026 events6 affected112 at risk
Pseudoaneurysm	Vascular disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0010 events0 affected123 at risk EG0021 events1 affected112 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected122 at risk EG0013 events3 affected123 at risk EG0027 events5 affected112 at risk
Renal failure/renal insufficiency	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected122 at risk EG0013 events3 affected123 at risk EG0022 events2 affected112 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0010 events0 affected123 at risk EG0022 events2 affected112 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events5 affected122 at risk EG0010 events0 affected123 at risk EG0022 events2 affected112 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events5 affected122 at risk EG0013 events3 affected123 at risk EG0025 events4 affected112 at risk
Respiratory infection, other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected122 at risk EG0010 events0 affected123 at risk EG0022 events2 affected112 at risk
Restenosis (non-target lesion)	Vascular disorders	Systematic Assessment	EG00013 events6 affected122 at risk EG00115 events6 affected123 at risk EG00211 events7 affected112 at risk
Restenosis of treated segment (target lesion)	Vascular disorders	Systematic Assessment	EG00015 events12 affected122 at risk EG00135 events22 affected123 at risk EG00212 events7 affected112 at risk
SARS, COVID-19	Infections and infestations	Systematic Assessment	EG0003 events3 affected122 at risk EG0011 events1 affected123 at risk EG0023 events3 affected112 at risk
Seizure	Nervous system disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0011 events1 affected123 at risk EG0021 events1 affected112 at risk
Sepsis or systemic infection	Infections and infestations	Systematic Assessment	EG0009 events8 affected122 at risk EG0019 events7 affected123 at risk EG0027 events6 affected112 at risk
Steal syndrome	Vascular disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0012 events2 affected123 at risk EG0020 events0 affected112 at risk
Stenosis (non-target)	Vascular disorders	Systematic Assessment	EG00011 events9 affected122 at risk EG0016 events6 affected123 at risk EG0028 events7 affected112 at risk
Stroke or other neurological complications	Nervous system disorders	Systematic Assessment	EG0005 events5 affected122 at risk EG0016 events4 affected123 at risk EG0024 events4 affected112 at risk
Symptomatic distal emboli, non-angiographic	Vascular disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0010 events0 affected123 at risk EG0020 events0 affected112 at risk
Thrombosis	Vascular disorders	Systematic Assessment	EG0008 events7 affected122 at risk EG0015 events3 affected123 at risk EG00233 events20 affected112 at risk
Total occlusion of the vascular access circuit	Vascular disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0010 events0 affected123 at risk EG0024 events4 affected112 at risk
Transient ischemic attack (TIA)	Nervous system disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0010 events0 affected123 at risk EG0020 events0 affected112 at risk
Urinary tract infection (UTI)	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0012 events2 affected123 at risk EG0020 events0 affected112 at risk
Vascular access complications	Vascular disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0011 events1 affected123 at risk EG0020 events0 affected112 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0011 events1 affected123 at risk EG0021 events1 affected112 at risk
Vessel rupture	Vascular disorders	Systematic Assessment	EG0001 events1 affected122 at risk EG0011 events1 affected123 at risk EG0021 events1 affected112 at risk
Vessel spasm or recoil	Vascular disorders	Systematic Assessment	EG0000 events0 affected122 at risk EG0011 events1 affected123 at risk EG0020 events0 affected112 at risk
Pain	General disorders	Systematic Assessment	EG0005 events4 affected122 at risk EG0014 events4 affected123 at risk EG0029 events8 affected112 at risk
Dialysis Access Complications	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events4 affected122 at risk EG0014 events2 affected123 at risk EG0028 events6 affected112 at risk

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

ID	Title	Description
BG000	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
BG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
BG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
BG003	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	AVF Peripheral Study Treatment Group	Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement	24	122	75	122	107	122
EG001	AVF Peripheral Control Group	Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)	25	123	85	123	121	123
EG002	AVG Anastomosis	All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement	21	112	82	112	104	112