WRAP North America

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Merit Medical Systems, Inc.
Study ID
NCT06807099
Status
Recruiting
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Conditions

  • Venous Occlusion
  • Venous Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE) — DEVICE
    Target Lesion treated with WRAPSODY CIE

Study Details

The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population. Participants treated with the WRAPSODY CIE device in accordance with the device instructions for use will be followed in accordance with standard of care up to 3-years post-procedure.

Key Dates

Start date
Jul 31, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2030

Study Design

Enrollment
250 participants (estimated)

Primary Outcome Measure

Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint) [ Time Frame: 6 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Trinity Research GroupDothanAlabama36301
Jason Beaver, MD (PRINCIPAL_INVESTIGATOR)
Sarasota Memorial Research InstituteSarasotaFlorida34239
Jason Wagner, MD (PRINCIPAL_INVESTIGATOR)
University of KentuckyLexingtonKentucky40536
Sayee Alagusundaramoorthy, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Adam Tanious, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaOrangeburgSouth Carolina29118
Mark London, MD (PRINCIPAL_INVESTIGATOR)
Spartanburg Medical SystemSpartanburgSouth Carolina29303
Ari Kramer, MD (PRINCIPAL_INVESTIGATOR)
Bluff City VascularMemphisTennessee38104
Omar Davis, MD (PRINCIPAL_INVESTIGATOR)
Texas Research InstituteFort WorthTexas76104
Saravanan Balamuthusamy, MD (PRINCIPAL_INVESTIGATOR)
Humble Vascular Surgical CenterHumbleTexas77338
Ruchdi Barakat, MD (PRINCIPAL_INVESTIGATOR)
San Antonio Kidney Disease CenterSan AntonioTexas78216
Rajeev Narayan, MD (PRINCIPAL_INVESTIGATOR)
Sentara Vascular SpecialistsVirginia BeachVirginia23507
David Dexter, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dothan, AL

By research site
Trinity Research Group· Dothan, ALSarasota Memorial Research Institute· Sarasota, FLUniversity of Kentucky· Lexington, KYMedical University of South Carolina· Charleston, SCMedical University of South Carolina· Orangeburg, SCSpartanburg Medical System· Spartanburg, SC

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