Venous StenosisWAVE CentralNCT04541576
The Merit WRAPSODY Central Feasibility Study
A study testing Merit WRAPSODY Endovascular Stent Graft in people with Venous Stenosis and Venous Occlusion, run by Merit Medical Systems, Inc..
Trial summary
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit in the thoracic central veins Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Stenosis, Venous Occlusion
- What is being tested?
- Merit WRAPSODY Endovascular Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject provides written informed consent
- Subject is male or female, with an age ≥ 18 years at date of enrollment.
- Subject is willing to undergo all follow-up assessments.
- Subject has a life expectancy ≥ 12 months.
- Subject is undergoing chronic hemodialysis.
- Subject has either a mature AVF or AVG in the arm.
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- Target lesion(s) involves a non-stented restenotic lesion.
- Target lesion has ≥50% stenosis.
- Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm
Who cannot join
- Subject is unable or is unwilling to comply with the procedural requirements of the study protocol.
- Subject has a comorbidity that in the investigator's opinion would limit life expectancy to less than 12 months.
- Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
- Subject has a stroke diagnosis within 3 months prior to enrollment.
- Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
- Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
- Target lesion is located within a stent / stent graft.
About this study
Official title: Prospective, Non-Randomized, Controlled, Multicenter Feasibility Study of the Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Central Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit in the thoracic central veins
- Conditions
- Venous Stenosis, Venous Occlusion
- Being tested
- Merit WRAPSODY Endovascular Stent Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Merit WRAPSODY Endovascular Stent GraftDevice
Target lesion treated with stent graft placement
| Study group | Role | What they receive |
|---|---|---|
| WRAPSODY Stent Graft | Experimental | All subjects will receive treatment via WRAPSODY Stent Graft Placement. Receives: Device: Merit WRAPSODY Endovascular Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint
Proportion 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 intervention, hospitalization, or death.
Measured: 30 days
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
Proportion 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.
Measured: 6 months
Secondary outcomes (5)
Proportion of subjects with Target Lesion Primary Patency
Measured: 12 and 24 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Measured: 6, 12 and 24 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Measured: 6, 12 and 24 months
Proportion of subjects with Post-Procedure Secondary Patency
Measured: 6, 12 and 24 months
Rates of procedure- and device-related adverse events involving the access circuit
Measured: Index procedure, 30 days, and months 6, 12 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study startMar 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: FDA Approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541576
- Sponsor's protocol ID
- CVO-P3-20-01-F
- Acronym
- WAVE Central
- Status last verified
- Apr 2021
- First submitted
- 1 Sep 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized, Controlled, Multicenter Feasibility Study of the Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Central Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04541576
- Acronym / sponsor ID
- WAVE Central / CVO-P3-20-01-F
- Conditions
- Venous Stenosis, Venous Occlusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA Approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit in the thoracic central veins
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WRAPSODY Stent Graft | Experimental | Device: Merit WRAPSODY Endovascular Stent GraftAll subjects will receive treatment via WRAPSODY Stent Graft Placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject provides written informed consent
- Subject is male or female, with an age ≥ 18 years at date of enrollment.
- Subject is willing to undergo all follow-up assessments.
- Subject has a life expectancy ≥ 12 months.
- Subject is undergoing chronic hemodialysis.
Key exclusion criteria (7 listed)
- Subject is unable or is unwilling to comply with the procedural requirements of the study protocol.
- Subject has a comorbidity that in the investigator's opinion would limit life expectancy to less than 12 months.
- Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
- Subject has a stroke diagnosis within 3 months prior to enrollment.
- Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
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 |
|---|---|---|
| Merit WRAPSODY Endovascular Stent GraftTarget lesion treated with stent graft placement | Device | WRAPSODY Stent Graft |
Primary outcome
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint
Time frame: 30 days
Proportion 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 intervention, hospitalization, or death.
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
Time frame: 6 months
Proportion 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.
5 secondary outcomes
Proportion of subjects with Target Lesion Primary Patency
Time frame: 12 and 24 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Time frame: 6, 12 and 24 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Time frame: 6, 12 and 24 months
Proportion of subjects with Post-Procedure Secondary Patency
Time frame: 6, 12 and 24 months
Rates of procedure- and device-related adverse events involving the access circuit
Time frame: Index procedure, 30 days, and months 6, 12 and 24.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Merit WRAPSODY Endovascular Stent Graft in people with Venous Stenosis and Venous Occlusion, run by Merit Medical Systems, Inc..
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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint (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 20 Apr 2021.