We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

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: NCT03869645
Recruitment Status : Terminated (Change in Sponsor)
First Posted : March 11, 2019
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
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.

Condition or disease Intervention/treatment
Observational Study Device: CAPERE Thrombectomy System

Detailed Description:

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CAPERE Thrombectomy System Post-Market Clinical Follow Up Study
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : August 26, 2020
Actual Study Completion Date : August 26, 2020

Intervention Details:
  • Device: CAPERE Thrombectomy System
    Mechanical thrombectomy of acute thrombus in peripheral vasculature with the CAPERE Thrombectomy System


Primary Outcome Measures :
  1. Restoration of blood flow [ Time Frame: Day 0 - Intervention ]
    Clearance of clot and restoration of venous flow of the affected vessel as confirmed using venogram immediately post-procedure


Secondary Outcome Measures :
  1. Device Success [ Time Frame: Day 0 ]
    Successful withdrawal of device along with clots without clinically significant emboli, permanent vessel trauma, entry site aneurysm, major bleeding complications

  2. Technical Success Rate [ Time Frame: Day 0 ]
    Ratio of successful thrombus removals and total number of participants

  3. Thrombus removal rate [ Time Frame: Day 0 ]
    percent of thrombus removal comparing pre-treatment to post-treatment venography

  4. VEINES Survey [ Time Frame: </= Day 0 and Day 30 ]
    Evaluation of quality of life (QoL) before and after treatment based on VEINES survey responses. Eight (8) QoL questions related to the patient's leg problems are evaluated and their scores aggregated into a single QoL score. The resultant aggregated QoL range is from 26 - 108 where the higher the number the higher the quality of life.

  5. Safety Endpoint [ Time Frame: 30 days ]
    Evaluation of the incidence of unanticipated adverse device events: estimated to be less than or equal to 5%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Adult patients with clinical symptoms of extremity swelling with ultrasound evidence of acute thrombosis in the peripheral vasculature.
Criteria

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

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): NCT03869645


Locations
Layout table for location information
United States, California
Memorial Health Services
Fountain Valley, California, United States, 92708
St. Joseph Hospital
Orange, California, United States, 92868
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Layout table for investigator information
Principal Investigator: Tiffany Wu, MD Unity Health Toronto
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT03869645    
Other Study ID Numbers: TP18-0009
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No