CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

NCT ID: NCT03869645

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-08-26

Brief Summary

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A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.

Detailed Description

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A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.

Subjects will be evaluated based on VEINES QoL survey pre- and post-treatment (30-days).

Conditions

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Observational Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CAPERE Thrombectomy System

Mechanical thrombectomy of acute thrombus in peripheral vasculature with the CAPERE Thrombectomy System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who are greater than or equal to 18 years of age
* Patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms \< 14 days
* Patients cleared medically for invasive endovenous procedures

Exclusion Criteria

* Patients with IVC filter in area to be treated
* Patients who are \< 18 years of age.
* Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated
* Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention
* Female who is pregnant or nursing
* Concurrent participation in another investigational drug or device treatment study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Endovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiffany Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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Memorial Health Services

Fountain Valley, California, United States

Site Status

St. Joseph Hospital

Orange, California, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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TP18-0009

Identifier Type: -

Identifier Source: org_study_id

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