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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03869645
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Vascular Medcure, Inc.

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
Estimated Enrollment : 40 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
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : November 1, 2021

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. 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.



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 > 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


Contacts
Layout table for location contacts
Contact: Jeffrey P DuMontelle 7149150886 jeff@vascularmedcure.com

Locations
Layout table for location information
United States, California
St. Joseph Hospital Recruiting
Orange, California, United States, 92868
Contact: Sandra Chung, BSN RN CCRC    714-744-8795    Sandy.Chung@stjoe.org   
Principal Investigator: Tiffany Wu, MD         
Sponsors and Collaborators
Vascular Medcure, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Tiffany Wu, MD Unity Health Toronto
Layout table for additonal information
Responsible Party: Vascular Medcure, Inc.
ClinicalTrials.gov Identifier: NCT03869645    
Other Study ID Numbers: TP18-0009
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
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