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RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 10 words
    • Study description revised
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Primary endpoints revised (2)
    • Study description shortened, about 3 words
    • Study title expanded, about 2 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical investigation is to learn if the Recana Thrombectomy Catheter System can treat chronic venous obstruction and occlusion in participants with symptomatic postthrombotic venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are: 1. primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure 2. primary efficacy endpoint: patency greater than or equal to 50 percent (%) lumen diameter achieved during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural) Participants are screened and qualified for the clinical investigation. Qualified participants (those that meet all eligibility criteria) will undergo treatment with the Recana Thrombectomy Catheter System. Participants are assessed at the following timepoints: 30, 90, 180 and 365 days post-procedure.
Trial Details
NCT Number NCT07095660
Lead Sponsor Intervene, Inc.
Conditions
(from sponsor)		 Venous Obstruction
Related terms Postthrombotic Syndrome
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov