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: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 2022
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.
- Device: JETi Thrombectomy System
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
- 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)
- 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.
- Technical Success
- Time Frame: 0 days
- Change in the degree of occlusion from baseline to final angiogram
Participating in This Clinical Trial
- 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.
- 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
- Lead Sponsor
- Walk Vascular LLC
- Provider of Information About this Clinical Study
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