Venous StenosisNCT03644017
The Merit WRAPSODY™ Endovascular Stent Graft
A study testing WRAPSODY Stent Graft Placement in people with Venous Stenosis and Venous Occlusion, run by Merit Medical Systems, Inc. at 3 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Venous Stenosis, Venous Occlusion
- What is being tested?
- WRAPSODY Stent Graft Placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 29 Jan 2019to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has signed informed consent
- Subject is ≥ 21 years of age
- 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
- Angiographic evidence of stenosis
- The target lesion has ≥ 50% stenosis
- Subject has clinical or hemodynamic evidence of a venous outflow stenosis or obstruction
- Full expansion of an appropriately sized standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment
Who cannot join
- Subject has undergone an intervention (surgical or percutaneous) of the AVF/AVG <30 days from the date of the initial study procedure
- 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
- Active hemodialysis access is not in the arm
- A pseudoaneurysm is present within the target lesion
- 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
- Lesions, other than the target lesion, in the venous outflow circuit with >30% stenosis
Show all 22Show fewer
- Known or suspected infection of the hemodialysis access site and/or septicemia
- Permanent pacemaker or automated implantable cardioverter defibrillator (AICD) on the side with the target lesion
- Current central venous catheter for dialysis access
- Uncorrectable coagulation disorders
- Hypersensitivity to nickel titanium alloy
- The subject is enrolled in another investigational study
- The subject is unable or unwilling to comply with the protocol requirements
- Life expectancy is ≤ 12 months
- Subject cannot receive heparin or equivalent anticoagulant
- Allergy to radiographic contrast material which cannot be adequately premedicated
- Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
- Subject's access is anticipated to be abandoned within 3 months
- Subject has a thoracic central vein obstruction that would lead to stent graft placement across the internal jugular vein
- Subject's hemodialysis access is thrombosed
- Active malignancy other than non-melanomatous skin cancer
- Any other condition deemed exclusionary in the opinion of the investigator
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
About this study
Official title: Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Venous Outflow Circuit Obstruction In Hemodialysis Patients
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.
- Conditions
- Venous Stenosis, Venous Occlusion
- Being tested
- WRAPSODY Stent Graft Placement
- Keywords
- Dialysis, Venous Stenosis, Venous Occlusion, Stent Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WRAPSODY Stent Graft PlacementDevice
Also called Stent Graft, Covered Stent
The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
| Study group | Role | What they receive |
|---|---|---|
| WRAPSODY Stent Graft | Experimental | All subjects will receive treatment via WRAPSODY Stent Graft Placement. Receives: Device: WRAPSODY Stent Graft Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Number of Participants With Target Lesion Primary Patency at 30 Days
The total number of subjects with Target Lesion Primary Patency at 30 days
Measured: 30 days
Secondary outcomes (18)
Number of Participants With Target Lesion Primary Patency at 3 Months
The total number of subjects with Target Lesion Primary Patency at 3 months
Measured: 3 months
Number of Participants With Target Lesion Primary Patency at 6 Months
The total number of subjects with Target Lesion Primary Patency at 6 months
Measured: 6 months
Number of Participants With Target Lesion Primary Patency at 12 Months
The total number of subjects with Target Lesion Primary Patency at 12 months
Measured: 12 months
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
Measured: 30 days
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
Measured: 3 months
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
Measured: 6 months
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
Measured: 12 months
Number of Participants With Access Circuit Primary Patency at 30 Days
The total number of subjects with Access Circuit Primary Patency at 30 days
Measured: 30 days
Number of Participants With Access Circuit Primary Patency at 3 Months
The total number of subjects with Access Circuit Primary Patency at 3 months
Measured: 3 months
Number of Participants With Access Circuit Primary Patency at 6 Months
The total number of subjects with Access Circuit Primary Patency at 6 months
Measured: 6 months
Number of Participants With Access Circuit Primary Patency at 12 Months
The total number of subjects with Access Circuit Primary Patency at 12 months
Measured: 12 months
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
Measured: 30 days
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
Measured: 3 months
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
Measured: 6 months
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
Measured: 12 months
Number of Participants With Clinical Success
The resumption of successful dialysis through existing access for at least one session following the initial study procedure
Measured: 30 days
Number of Participants With Anatomic Success
Less than 30% residual stenosis immediately following the study procedure
Measured: Immediately following the study procedure
Number of Participants With Procedural Success
The achievement of both clinical and anatomic success
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start29 Jan 2019
- Primary completion25 Feb 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm treated with investigational device WRAPSODY Stent Graft
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James A Gilbert, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644017
- Sponsor's protocol ID
- CVO-P1-18-01
- Status last verified
- Dec 2021
- First submitted
- 16 Aug 2018
- Last updated
- 21 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Venous Outflow Circuit Obstruction In Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03644017
- Acronym / sponsor ID
- CVO-P1-18-01
- Conditions
- Venous Stenosis, Venous Occlusion
- Keywords
- Dialysis, Venous Stenosis, Venous Occlusion, Stent Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Posted 21 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm treated with investigational device WRAPSODY Stent Graft
| Arm | Type | Receives |
|---|---|---|
| WRAPSODY Stent Graft | Experimental | Device: WRAPSODY Stent Graft PlacementAll subjects will receive treatment via WRAPSODY Stent Graft Placement. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has signed informed consent
- Subject is ≥ 21 years of age
- 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
- Angiographic evidence of stenosis
- The target lesion has ≥ 50% stenosis
Key exclusion criteria (22 listed)
- Subject has undergone an intervention (surgical or percutaneous) of the AVF/AVG <30 days from the date of the initial study procedure
- 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
- Active hemodialysis access is not in the arm
- A pseudoaneurysm is present within the target lesion
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WRAPSODY Stent Graft PlacementAlso: Stent Graft, Covered StentThe stent graft will be placed into a target lesion (stenosis or occlusion) of a vein | Device | WRAPSODY Stent Graft |
Primary outcome
Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days
Time frame: 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
Number of Participants With Target Lesion Primary Patency at 30 Days
Time frame: 30 days
The total number of subjects with Target Lesion Primary Patency at 30 days
18 secondary outcomes
Number of Participants With Target Lesion Primary Patency at 3 Months
Time frame: 3 months
Number of Participants With Target Lesion Primary Patency at 6 Months
Time frame: 6 months
Number of Participants With Target Lesion Primary Patency at 12 Months
Time frame: 12 months
Number of Participants With Assisted Target Lesion Primary Patency at 30 Days
Time frame: 30 days
Number of Participants With Assisted Target Lesion Primary Patency at 3 Months
Time frame: 3 months
Number of Participants With Assisted Target Lesion Primary Patency at 6 Months
Time frame: 6 months
Number of Participants With Assisted Target Lesion Primary Patency at 12 Months
Time frame: 12 months
Number of Participants With Access Circuit Primary Patency at 30 Days
Time frame: 30 days
Number of Participants With Access Circuit Primary Patency at 3 Months
Time frame: 3 months
Number of Participants With Access Circuit Primary Patency at 6 Months
Time frame: 6 months
Number of Participants With Access Circuit Primary Patency at 12 Months
Time frame: 12 months
Number of Participants With Assisted Access Circuit Primary Patency at 30 Days
Time frame: 30 days
Number of Participants With Assisted Access Circuit Primary Patency at 3 Months
Time frame: 3 months
Number of Participants With Assisted Access Circuit Primary Patency at 6 Months
Time frame: 6 months
Number of Participants With Assisted Access Circuit Primary Patency at 12 Months
Time frame: 12 months
Number of Participants With Clinical Success
Time frame: 30 days
Number of Participants With Anatomic Success
Time frame: Immediately following the study procedure
Number of Participants With Procedural Success
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Venous Stenosis
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
RecruitingObservational study
Abbott Vascular Medical Device Registry
Acute Myocardial Infarction, Restenoses, Coronary
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Recruiting
The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
Venous Stenosis, Venous Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Gilbert, MD principal investigator
Oxford University Hospitals NHS Trust
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WRAPSODY Stent Graft Placement in people with Venous Stenosis and Venous Occlusion, run by Merit Medical Systems, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.