Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05062291 |
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Recruitment Status :
Recruiting
First Posted : September 30, 2021
Last Update Posted : April 26, 2023
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Sponsor:
Merit Medical Systems, Inc.
Information provided by (Responsible Party):
Merit Medical Systems, Inc.
- Study Details
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Brief Summary:
The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.
| Condition or disease | Intervention/treatment |
|---|---|
| Venous Stenosis Venous Occlusion | Device: Merit WRAPSODY Endovascular Stent Graft |
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit of an Arteriovenous (AVF) Fistula or AV Graft (AVG) (The WRAP Registry) |
| Actual Study Start Date : | June 23, 2022 |
| Estimated Primary Completion Date : | September 2024 |
| Estimated Study Completion Date : | September 2026 |
Intervention Details:
- Device: Merit WRAPSODY Endovascular Stent Graft
Target Lesion Primary Patency (TLPP)
Primary Outcome Measures :
- 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.
- 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 reintervention, hospitalization, or death (not including stenosis or thrombosis).
Secondary Outcome Measures :
- Proportion of subjects with Target Lesion Primary Patency [ Time Frame: 12 and 24 months ]Proportion of subjects with Target Lesion Primary Patency
- Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP) [ Time Frame: 6, 12 and 24 months ]Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
- Proportion of subjects with Access Circuit Primary Patency (ACPP) [ Time Frame: 6, 12 and 24 months ]Proportion of subjects with Access Circuit Primary Patency (ACPP)
- Rates of procedure- and device-related adverse events [ Time Frame: Index procedure, 30 days, and months 6 ]Rates of procedure- and device-related adverse events
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The registry will include peripheral cases in both AV graft and AV fistula patients (including at the graft vein anastomosis of an AVG patient) and thoracic central patients in both AV graft and AV fistula patients.
Criteria
Inclusion Criteria:
- Subject provides written informed consent for study participation.
- Subject is male or female, with an age ≥ 18 years at date of enrollment.
- Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 24 months.
- Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon
- The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
- Subject has stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System in accordance with device instructions for use.
Exclusion Criteria:
- Subject has a planned surgical revision of access site.
- Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
- Subject has an uncorrectable coagulation disorder.
- Known hypersensitivity to nickel titanium alloy.
- Subject's hemodialysis access is anticipated to be abandoned within 6 months.
- Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
- Full expansion of a Percutaneous Transluminal Angioplasty (PTA) balloon cannot be achieved during predilatation.
- Device would be placed in the Superior Vena Cava
- Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05062291
Contacts
| Contact: Christopher Weeks | +1-385-766-9138 | christopher.weeks@merit.com | |
| Contact: Vicky Brunk, MS | wrap@merit.com |
Locations
Show 28 study locations
Sponsors and Collaborators
Merit Medical Systems, Inc.
Investigators
| Principal Investigator: | Dheeraj Rajan, MD | University of Toronto | |
| Principal Investigator: | Panagiotis Kitrou | University Hospital of Patras |
| Responsible Party: | Merit Medical Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT05062291 |
| Other Study ID Numbers: |
CVO-P4-21-01 |
| First Posted: | September 30, 2021 Key Record Dates |
| Last Update Posted: | April 26, 2023 |
| Last Verified: | April 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Merit Medical Systems, Inc.:
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Arteriovenous Fistula (AVF) Arteriovenous Graft (AVG) AV fistula AV graft |
Additional relevant MeSH terms:
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Constriction, Pathologic Pathological Conditions, Anatomical |