JET Enhanced Thrombectomy Intervention

Overview

Evaluate real world patient outcomes after treatment of acute and non-acute upper and lower extremity venous and arterial thrombosis with the JETi Thrombectomy System.

Full Title of Study: “JET Enhanced Thrombectomy Intervention – JETi Registry”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2022

Detailed Description

The JETi Registry is an open label, prospective, non-randomized, multi-center observational registry including 250 patients who meet eligibility from up to 30 sites worldwide. Patient participation will be 12 months including post procedure follow-up contact at 10 days, 3, 6 and 12 months. The study duration is estimated at 36 months.

Interventions

  • Device: JETi Thrombectomy System
    • Thrombectomy

Arms, Groups and Cohorts

  • Deep Vein Thrombosis
    • Patients presenting with deep vein thrombosis for treatment
  • Limb Ischemia
    • Patients presenting with limb ischemia
  • Hemodialysis Access
    • Patients presenting with thrombosed hemodialysis access for treatment
  • Other Thrombotic Conditions
    • Patients presenting with a thrombotic condition other than deep vein thrombosis, limb ischemia or thrombosed hemodialysis access for treatment

Clinical Trial Outcome Measures

Primary Measures

  • Change in Percent of Occlusion From Baseline to Final Angiogram/Venogram
    • Time Frame: 0 days
    • From the Index Procedure’s Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, each vessel will be assigned a value by the independent core lab. Complete occlusion (>90% occlusion) Substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length) Partial occlusion (<50% occlusion AND <3cm in length) Patent/Normal (without visible thrombus or occlusion)
  • Rethrombosis
    • Time Frame: up to 12 Month Follow Up
    • The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.

Secondary Measures

  • Technical Success
    • Time Frame: 0 days
    • Change in the degree of occlusion from baseline to final angiogram

Participating in This Clinical Trial

Inclusion Criteria

  • Patient has been treated for acute/sub-acute thrombosis in the peripheral vascular system with any of the JETi® Peripheral Thrombectomy System Catheters
  • Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.
  • Age ≥ 18 years.

Exclusion Criteria

  • Patient has previously been enrolled in JETi Registry in the last 12 months.
  • Current participation in another drug or device trial.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Walk Vascular LLC
  • Provider of Information About this Clinical Study
    • Sponsor

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