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CompletedNCT03644017Updated Jan 21, 2022Results posted

The Merit WRAPSODY™ Endovascular Stent Graft

An interventional study of WRAPSODY Stent Graft Placement in Venous Stenosis and Venous Occlusion, sponsored by Merit Medical Systems, Inc.. Completed at 3 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-01-21.

Sponsored by Merit Medical Systems, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Venous Stenosis
  • Venous Occlusion

Keywords

  • Dialysis
  • Venous Stenosis
  • Venous Occlusion
  • Stent Graft
03

In context

Constriction, Pathologic

1,117 studies on the registry are indexed under Constriction, Pathologic; 231 are open to participants now.

This study's enrollment of 46 is below the median of 80 across 672 interventional studies indexed under Constriction, Pathologic.

Browse Constriction, Pathologic studies →

Lead sponsor

Merit Medical Systems, Inc. is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    WRAPSODY Stent Graft

    All subjects will receive treatment via WRAPSODY Stent Graft Placement.

    Device: WRAPSODY Stent Graft Placement

Interventions

  • DeviceWRAPSODY Stent Graft Placement

    The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein

    Also known as: Stent Graft, Covered Stent

06

What researchers measure

Primary outcomes

  1. Number of Participants Without Any Localized or Systemic Safety Events Through 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

    Time frame: 30 days

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

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

    Time frame: 30 days

Secondary outcomes

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

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 30 days

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

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 30 days

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

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 30 days

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

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

  16. Number of Participants With Clinical Success

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

    Time frame: 30 days

  17. Number of Participants With Anatomic Success

    Less than 30% residual stenosis immediately following the study procedure

    Time frame: Immediately following the study procedure

  18. Number of Participants With Procedural Success

    The achievement of both clinical and anatomic success

    Time frame: 30 days

Other outcomes

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

    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

07

Results

Posted Jul 21, 2021

Participant flow

Participant flow — Overall Study
MilestoneWRAPSODY Stent Graft
Started46
Completed39
Not completed7
Withdrew: Access abandonment5
Withdrew: Kidney transplant2

Outcome measures

PrimaryNumber of Participants Without Any Localized or Systemic Safety Events Through 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

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days
ParticipantsWRAPSODY Stent Graft
Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days45
PrimaryNumber of Participants With Target Lesion Primary Patency at 30 Days

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

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Primary Patency at 30 Days
ParticipantsWRAPSODY Stent Graft
Number of Participants With Target Lesion Primary Patency at 30 Days45
SecondaryNumber of Participants With Target Lesion Primary Patency at 3 Months

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

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Primary Patency at 3 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Target Lesion Primary Patency at 3 Months44
SecondaryNumber of Participants With Target Lesion Primary Patency at 6 Months

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

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Primary Patency at 6 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Target Lesion Primary Patency at 6 Months42
SecondaryNumber of Participants With Target Lesion Primary Patency at 12 Months

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

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Primary Patency at 12 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Target Lesion Primary Patency at 12 Months33
SecondaryNumber of Participants With Assisted Target Lesion Primary Patency at 30 Days

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

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Assisted Target Lesion Primary Patency at 30 Days
ParticipantsWRAPSODY Stent Graft
Number of Participants With Assisted Target Lesion Primary Patency at 30 Days45
SecondaryNumber of Participants With Assisted Target Lesion Primary Patency at 3 Months

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

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Assisted Target Lesion Primary Patency at 3 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Assisted Target Lesion Primary Patency at 3 Months44
SecondaryNumber of Participants With Assisted Target Lesion Primary Patency at 6 Months

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

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Assisted Target Lesion Primary Patency at 6 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Assisted Target Lesion Primary Patency at 6 Months43
SecondaryNumber of Participants With Assisted Target Lesion Primary Patency at 12 Months

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

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants With Assisted Target Lesion Primary Patency at 12 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Assisted Target Lesion Primary Patency at 12 Months39
SecondaryNumber of Participants With Access Circuit Primary Patency at 30 Days

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

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Access Circuit Primary Patency at 30 Days
ParticipantsWRAPSODY Stent Graft
Number of Participants With Access Circuit Primary Patency at 30 Days43
SecondaryNumber of Participants With Access Circuit Primary Patency at 3 Months

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

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Access Circuit Primary Patency at 3 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Access Circuit Primary Patency at 3 Months40
SecondaryNumber of Participants With Access Circuit Primary Patency at 6 Months

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

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Access Circuit Primary Patency at 6 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Access Circuit Primary Patency at 6 Months38
SecondaryNumber of Participants With Access Circuit Primary Patency at 12 Months

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

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants With Access Circuit Primary Patency at 12 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Access Circuit Primary Patency at 12 Months29
SecondaryNumber of Participants With Assisted Access Circuit Primary Patency at 30 Days

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

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Assisted Access Circuit Primary Patency at 30 Days
ParticipantsWRAPSODY Stent Graft
Number of Participants With Assisted Access Circuit Primary Patency at 30 Days45
SecondaryNumber of Participants With Assisted Access Circuit Primary Patency at 3 Months

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

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Assisted Access Circuit Primary Patency at 3 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Assisted Access Circuit Primary Patency at 3 Months44
SecondaryNumber of Participants With Assisted Access Circuit Primary Patency at 6 Months

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

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Assisted Access Circuit Primary Patency at 6 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Assisted Access Circuit Primary Patency at 6 Months43
SecondaryNumber of Participants With Assisted Access Circuit Primary Patency at 12 Months

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

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants With Assisted Access Circuit Primary Patency at 12 Months
ParticipantsWRAPSODY Stent Graft
Number of Participants With Assisted Access Circuit Primary Patency at 12 Months39
SecondaryNumber of Participants With Clinical Success

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

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Clinical Success
ParticipantsWRAPSODY Stent Graft
Number of Participants With Clinical Success45
SecondaryNumber of Participants With Anatomic Success

Less than 30% residual stenosis immediately following the study procedure

Time frame:
Immediately following the study procedure
Reported as:
Count of participants · Participants
Number of Participants With Anatomic Success
ParticipantsWRAPSODY Stent Graft
Number of Participants With Anatomic Success46
SecondaryNumber of Participants With Procedural Success

The achievement of both clinical and anatomic success

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Procedural Success
ParticipantsWRAPSODY Stent Graft
Number of Participants With Procedural Success45
Other pre-specifiedNumber of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only)

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
Reported as:
Count of participants · Participants
Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only)
ParticipantsWRAPSODY Stent Graft
Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only)8

Adverse events

Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
WRAPSODY Stent Graft0/46 (0%)10/46 (21.7%)0/46 (0%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventWRAPSODY Stent Graft
PneumoniaInfections and infestations3/46
Arteriovenous fistula thrombosisInjury, poisoning and procedural complications2/46
Arteriovenous graft thrombosisInjury, poisoning and procedural complications2/46
DyspnoeaRespiratory, thoracic and mediastinal disorders1/46
Myocardial infarctionCardiac disorders1/46
Extradural haematomaInjury, poisoning and procedural complications1/46
Device dislocationProduct Issues1/46
FallInjury, poisoning and procedural complications1/46
AnaemiaBlood and lymphatic system disorders1/46
Coronavirus test positiveInvestigations1/46

Baseline characteristics

Age, Continuous
Age, Continuous(years)WRAPSODY Stent Graft
Mean66.7 ± 12.87
Sex: Female, Male
Sex: Female, Male(Participants)WRAPSODY Stent Graft
Female24
Male22
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)WRAPSODY Stent Graft
Hispanic or Latino0
Not Hispanic or Latino45
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)WRAPSODY Stent Graft
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American4
White39
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)WRAPSODY Stent Graft
Greece23
United Kingdom23
08

Study locations

3 sites
  • G. Gennimatas General Hospital of Athens
    Athens, 115 27, Greece
  • Queen Elizabeth University Hospital
    Glasgow, G51 4TF, United Kingdom
  • Oxford University Hospitals NHS Foundation Trust
    Oxford, OX3 7LE, United Kingdom
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 7, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03644017
Lead sponsor
Merit Medical Systems, Inc.
Responsible party
Sponsor
First posted
Aug 23, 2018
Start date
Jan 29, 2019
Primary completion
Feb 25, 2020
Completion
Jan 20, 2021
Results posted
Jul 21, 2021
Last update
Jan 21, 2022

Study contacts

James A Gilbert, MD
principal investigator · Oxford University Hospitals NHS Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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