The Merit WRAPSODY Central Feasibility Study

Venous Occlusion Clinical Trial

— WAVE Central  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04541576
• Other study ID #: CVO-P3-20-01-F
• Status: Withdrawn
• Phase: N/A
• Start date: March 2021
• Est. completion date: February 2024

Study information

• Verified date: April 2021
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2024
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.
• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Venous Occlusion
• Venous Stenosis

Intervention

Device:
• Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.	ClinLogix. LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Primary	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.	6 months
Secondary	Proportion of subjects with Target Lesion Primary Patency		12 and 24 months
Secondary	Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)		6, 12 and 24 months
Secondary	Proportion of subjects with Access Circuit Primary Patency (ACPP)		6, 12 and 24 months
Secondary	Proportion of subjects with Post-Procedure Secondary Patency		6, 12 and 24 months
Secondary	Rates of procedure- and device-related adverse events involving the access circuit		Index procedure, 30 days, and months 6, 12 and 24.