The Merit WRAPSODY™ Endovascular Stent Graft

• Sponsor: Merit Medical Systems, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03644017
• Collaborator: (none)
• Enrollment: 46
• Locations: 3
• Arm: 1
• Actual Duration (Months): 23.7
• Patients Per Site: 15.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This is a phase 1 study, designed to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of venous outflow circuit obstructions in the veins of the arm or thoracic central veins of subjects who receive chronic dialysis treatment for end stage renal disease.

Condition or Disease	Intervention/Treatment	Phase
Venous Stenosis; Venous Occlusion	Device: WRAPSODY Stent Graft Placement	N/A

Detailed Description

The study will consist of a screening period in which subject eligibility will be determined. Approximately 50 subjects meeting the study entry criteria will be enrolled. Placement of the WRAPSODY stent graft will follow the procedure. Post study procedure subjects will have planned follow-up visits at 30 days, 3, 6 and 12months, and additional visits as referred by the subject's dialysis facility.

The primary study safety endpoint will be the proportion of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death. Subjects will continue to be followed up to 12 months for supplementary information.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single arm treated with investigational device WRAPSODY Stent GraftSingle arm treated with investigational device WRAPSODY Stent Graft
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Venous Outflow Circuit Obstruction In Hemodialysis Patients
• Actual Study Start Date: Jan 29, 2019
• Actual Primary Completion Date: Feb 25, 2020
• Actual Study Completion Date: Jan 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WRAPSODY Stent Graft All subjects will receive treatment via WRAPSODY Stent Graft Placement.	Device: WRAPSODY Stent Graft Placement; The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein; Other Names: Stent Graft Covered Stent

Outcome Measures

Primary Outcome Measures

1. Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days [30 days]

   The total number of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death

2. Number of Participants With Target Lesion Primary Patency at 30 Days [30 days]

   The total number of subjects with Target Lesion Primary Patency at 30 days

Secondary Outcome Measures

1. Number of Participants With Target Lesion Primary Patency at 3 Months [3 months]

   The total number of subjects with Target Lesion Primary Patency at 3 months

2. Number of Participants With Target Lesion Primary Patency at 6 Months [6 months]

   The total number of subjects with Target Lesion Primary Patency at 6 months

3. Number of Participants With Target Lesion Primary Patency at 12 Months [12 months]

   The total number of subjects with Target Lesion Primary Patency at 12 months

4. Number of Participants With Assisted Target Lesion Primary Patency at 30 Days [30 days]

   The total number of subjects with Assisted Primary Patency of the Target Lesion at 30 days

5. Number of Participants With Assisted Target Lesion Primary Patency at 3 Months [3 months]

   The total number of subjects with Assisted Primary Patency of the Target Lesion at 3 months

6. Number of Participants With Assisted Target Lesion Primary Patency at 6 Months [6 months]

   The total number of subjects with Assisted Primary Patency of the Target Lesion at 6 months

7. Number of Participants With Assisted Target Lesion Primary Patency at 12 Months [12 months]

   The total number of subjects with Assisted Primary Patency of the Target Lesion at 12 months

8. Number of Participants With Access Circuit Primary Patency at 30 Days [30 days]

   The total number of subjects with Access Circuit Primary Patency at 30 days

9. Number of Participants With Access Circuit Primary Patency at 3 Months [3 months]

   The total number of subjects with Access Circuit Primary Patency at 3 months

10. Number of Participants With Access Circuit Primary Patency at 6 Months [6 months]

    The total number of subjects with Access Circuit Primary Patency at 6 months

11. Number of Participants With Access Circuit Primary Patency at 12 Months [12 months]

    The total number of subjects with Access Circuit Primary Patency at 12 months

12. Number of Participants With Assisted Access Circuit Primary Patency at 30 Days [30 days]

    The total number of subjects with Assisted Access Circuit Primary Patency at 30 days

13. Number of Participants With Assisted Access Circuit Primary Patency at 3 Months [3 months]

    The total number of subjects with Assisted Access Circuit Primary Patency at 3 months

14. Number of Participants With Assisted Access Circuit Primary Patency at 6 Months [6 months]

    The total number of subjects with Assisted Access Circuit Primary Patency at 6 months

15. Number of Participants With Assisted Access Circuit Primary Patency at 12 Months [12 months]

    The total number of subjects with Assisted Access Circuit Primary Patency at 12 months

16. Number of Participants With Clinical Success [30 days]

    The resumption of successful dialysis through existing access for at least one session following the initial study procedure

17. Number of Participants With Anatomic Success [Immediately following the study procedure]

    Less than 30% residual stenosis immediately following the study procedure

18. Number of Participants With Procedural Success [30 days]

    The achievement of both clinical and anatomic success

Other Outcome Measures

1. Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only) [12 months]

   Total number of participants (subset of subjects with thoracic central venous target lesions only) with freedom from stent graft fracture, defined as clear interruption of a stent strut observed in a minimum of two projections taken during the 12 month visit or after determined by DMC/CEC examination of X-Ray images.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject has signed informed consent

2. Subject is ≥ 21 years of age

3. Subject is undergoing chronic hemodialysis or other forms of renal replacement therapy including transplantation and has one of the following being used: a. AV graft placed in the arm ≥30 days prior OR b. Mature fistula in the arm with at least one successful dialysis session completed

4. Angiographic evidence of stenosis

5. The target lesion has ≥ 50% stenosis

6. Subject has clinical or hemodynamic evidence of a venous outflow stenosis or obstruction

7. Full expansion of an appropriately sized standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment

Exclusion Criteria:

1. Subject has undergone an intervention (surgical or percutaneous) of the AVF/AVG <30 days from the date of the initial study procedure

2. Subject has had a previous stent or stent graft placed in the venous outflow circuit ≤30 days from the date of the initial study procedure

3. Active hemodialysis access is not in the arm

4. A pseudoaneurysm is present within the target lesion

5. Target lesion is in SVC, IJV, under the clavicle, across the elbow, in the needling segment of AVF or AVG anastomosis, located within a stent

6. Lesions, other than the target lesion, in the venous outflow circuit with >30% stenosis

7. Known or suspected infection of the hemodialysis access site and/or septicemia

8. Permanent pacemaker or automated implantable cardioverter defibrillator (AICD) on the side with the target lesion

9. Current central venous catheter for dialysis access

10. Uncorrectable coagulation disorders

11. Hypersensitivity to nickel titanium alloy

12. The subject is enrolled in another investigational study

13. The subject is unable or unwilling to comply with the protocol requirements

14. Life expectancy is ≤ 12 months

15. Subject cannot receive heparin or equivalent anticoagulant

16. Allergy to radiographic contrast material which cannot be adequately premedicated

17. Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant

18. Subject's access is anticipated to be abandoned within 3 months

19. Subject has a thoracic central vein obstruction that would lead to stent graft placement across the internal jugular vein

20. Subject's hemodialysis access is thrombosed

21. Active malignancy other than non-melanomatous skin cancer

22. Any other condition deemed exclusionary in the opinion of the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	G. Gennimatas General Hospital of Athens	Athens		Greece	115 27
2	Queen Elizabeth University Hospital	Glasgow		United Kingdom	G51 4TF
3	Oxford University Hospitals NHS Foundation Trust	Oxford		United Kingdom	OX3 7LE

Sponsors and Collaborators

• Merit Medical Systems, Inc.

Investigators

• Principal Investigator: James A Gilbert, MD, Oxford University Hospitals NHS Trust

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 7, 2020

More Information

Publications

None provided.

• Responsible Party: Merit Medical Systems, Inc.
• ClinicalTrials.gov Identifier: NCT03644017
• Other Study ID Numbers: CVO-P1-18-01
• First Posted: Aug 23, 2018
• Last Update Posted: Jan 21, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Merit Medical Systems, Inc.: Dialysis; Venous Stenosis; Venous Occlusion; Stent Graft
• Additional relevant MeSH terms: Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Period Title: Overall Study
STARTED	46
COMPLETED	39
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Overall Participants	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.7 (12.87)
Sex: Female, Male (Count of Participants)
Female	24 52.2%
Male	22 47.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	45 97.8%
Unknown or Not Reported	1 2.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 4.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 8.7%
White	39 84.8%
More than one race	1 2.2%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Greece	23 50%
United Kingdom	23 50%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days
Description	The total number of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	46
Count of Participants [Participants]	45 97.8%

2. Primary Outcome

Title	Number of Participants With Target Lesion Primary Patency at 30 Days
Description	The total number of subjects with Target Lesion Primary Patency at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	45 97.8%

3. Secondary Outcome

Title	Number of Participants With Target Lesion Primary Patency at 3 Months
Description	The total number of subjects with Target Lesion Primary Patency at 3 months
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	44
Count of Participants [Participants]	44 95.7%

4. Secondary Outcome

Title	Number of Participants With Target Lesion Primary Patency at 6 Months
Description	The total number of subjects with Target Lesion Primary Patency at 6 months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	43
Count of Participants [Participants]	42 91.3%

5. Secondary Outcome

Title	Number of Participants With Target Lesion Primary Patency at 12 Months
Description	The total number of subjects with Target Lesion Primary Patency at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	39
Count of Participants [Participants]	33 71.7%

6. Secondary Outcome

Title	Number of Participants With Assisted Target Lesion Primary Patency at 30 Days
Description	The total number of subjects with Assisted Primary Patency of the Target Lesion at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	45 97.8%

7. Secondary Outcome

Title	Number of Participants With Assisted Target Lesion Primary Patency at 3 Months
Description	The total number of subjects with Assisted Primary Patency of the Target Lesion at 3 months
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	44
Count of Participants [Participants]	44 95.7%

8. Secondary Outcome

Title	Number of Participants With Assisted Target Lesion Primary Patency at 6 Months
Description	The total number of subjects with Assisted Primary Patency of the Target Lesion at 6 months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	43
Count of Participants [Participants]	43 93.5%

9. Secondary Outcome

Title	Number of Participants With Assisted Target Lesion Primary Patency at 12 Months
Description	The total number of subjects with Assisted Primary Patency of the Target Lesion at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	39
Count of Participants [Participants]	39 84.8%

10. Secondary Outcome

Title	Number of Participants With Access Circuit Primary Patency at 30 Days
Description	The total number of subjects with Access Circuit Primary Patency at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	43 93.5%

11. Secondary Outcome

Title	Number of Participants With Access Circuit Primary Patency at 3 Months
Description	The total number of subjects with Access Circuit Primary Patency at 3 months
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	40 87%

12. Secondary Outcome

Title	Number of Participants With Access Circuit Primary Patency at 6 Months
Description	The total number of subjects with Access Circuit Primary Patency at 6 months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	38 82.6%

13. Secondary Outcome

Title	Number of Participants With Access Circuit Primary Patency at 12 Months
Description	The total number of subjects with Access Circuit Primary Patency at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	44
Count of Participants [Participants]	29 63%

14. Secondary Outcome

Title	Number of Participants With Assisted Access Circuit Primary Patency at 30 Days
Description	The total number of subjects with Assisted Access Circuit Primary Patency at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	45 97.8%

15. Secondary Outcome

Title	Number of Participants With Assisted Access Circuit Primary Patency at 3 Months
Description	The total number of subjects with Assisted Access Circuit Primary Patency at 3 months
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	44 95.7%

16. Secondary Outcome

Title	Number of Participants With Assisted Access Circuit Primary Patency at 6 Months
Description	The total number of subjects with Assisted Access Circuit Primary Patency at 6 months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	43 93.5%

17. Secondary Outcome

Title	Number of Participants With Assisted Access Circuit Primary Patency at 12 Months
Description	The total number of subjects with Assisted Access Circuit Primary Patency at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	44
Count of Participants [Participants]	39 84.8%

18. Secondary Outcome

Title	Number of Participants With Clinical Success
Description	The resumption of successful dialysis through existing access for at least one session following the initial study procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	45 97.8%

19. Secondary Outcome

Title	Number of Participants With Anatomic Success
Description	Less than 30% residual stenosis immediately following the study procedure
Time Frame	Immediately following the study procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	46
Count of Participants [Participants]	46 100%

20. Secondary Outcome

Title	Number of Participants With Procedural Success
Description	The achievement of both clinical and anatomic success
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	45
Count of Participants [Participants]	45 97.8%

21. Other Pre-specified Outcome

Title	Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only)
Description	Total number of participants (subset of subjects with thoracic central venous target lesions only) with freedom from stent graft fracture, defined as clear interruption of a stent strut observed in a minimum of two projections taken during the 12 month visit or after determined by DMC/CEC examination of X-Ray images.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Measure Participants	8
Count of Participants [Participants]	8 17.4%

Adverse Events

Time Frame	12 months
Arm/Group Title	WRAPSODY Stent Graft
Arm/Group Description	All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
All Cause Mortality
	WRAPSODY Stent Graft
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Serious Adverse Events
	WRAPSODY Stent Graft
	Affected / at Risk (%)	# Events
Total	10/46 (21.7%)
Blood and lymphatic system disorders
Anaemia	1/46 (2.2%)	1
Cardiac disorders
Myocardial infarction	1/46 (2.2%)	1
Acute myocardial infarction	1/46 (2.2%)	1
Infections and infestations
Pneumonia	3/46 (6.5%)	3
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis	2/46 (4.3%)	2
Arteriovenous graft thrombosis	2/46 (4.3%)	2
Extradural haematoma	1/46 (2.2%)	1
Fall	1/46 (2.2%)	1
Investigations
Coronavirus test positive	1/46 (2.2%)	1
Product Issues
Device dislocation	1/46 (2.2%)	1
Renal and urinary disorders
Renal failure	1/46 (2.2%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/46 (2.2%)	2
Other (Not Including Serious) Adverse Events
	WRAPSODY Stent Graft
	Affected / at Risk (%)	# Events
Total	0/46 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.