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JET Enhanced Thrombectomy Intervention (JETi)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04370691
Recruitment Status : Enrolling by invitation
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Walk Vascular LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Peripheral Artery Thrombosis Embolism Limb Ischemia Deep Vein Thrombosis Hemodialysis Access Thrombosis Peripheral Vascular Disease Device: JETi Thrombectomy System

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: JET Enhanced Thrombectomy Intervention - JETi Registry
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Groups and Cohorts
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Group/Cohort Intervention/treatment
Deep Vein Thrombosis
Patients presenting with deep vein thrombosis for treatment
 Device: JETi Thrombectomy System
Thrombectomy
Limb Ischemia
Patients presenting with limb ischemia
 Device: JETi Thrombectomy System
Thrombectomy
Hemodialysis Access
Patients presenting with thrombosed hemodialysis access for treatment
 Device: JETi Thrombectomy System
Thrombectomy
Other Thrombotic Conditions
Patients presenting with a thrombotic condition other than deep vein thrombosis, limb ischemia or thrombosed hemodialysis access for treatment
 Device: JETi Thrombectomy System
Thrombectomy


Outcome Measures
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Primary Outcome Measures :
  1. 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.

    1. Complete occlusion (>90% occlusion)
    2. Substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length)
    3. Partial occlusion (<50% occlusion AND <3cm in length)
    4. Patent/Normal (without visible thrombus or occlusion)

  2. 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 Outcome Measures :
  1. Technical Success [ Time Frame: 0 days ]
    Change in the degree of occlusion from baseline to final angiogram


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Population
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370691


Locations
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United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Walk Vascular LLC
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Walk Vascular LLC
ClinicalTrials.gov Identifier: NCT04370691    
Other Study ID Numbers: Rev: 03 September 2019
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Embolism
Vascular Diseases
Venous Thrombosis
Peripheral Vascular Diseases
Peripheral Arterial Disease
Ischemia
 Pathologic Processes
Embolism and Thrombosis
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases