CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

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.

Study Overview

• Status: Terminated
• Conditions: Observational Study
• Intervention / Treatment: 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).

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Memorial Health Services
    • Orange, California, United States, 92868
      • St. Joseph Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration of blood flow	Clearance of clot and restoration of venous flow of the affected vessel as confirmed using venogram immediately post-procedure	Day 0 - Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Successful withdrawal of device along with clots without clinically significant emboli, permanent vessel trauma, entry site aneurysm, major bleeding complications	Day 0
Technical Success Rate	Ratio of successful thrombus removals and total number of participants	Day 0
Thrombus removal rate	percent of thrombus removal comparing pre-treatment to post-treatment venography	Day 0
VEINES Survey	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.	</= Day 0 and Day 30
Safety Endpoint	Evaluation of the incidence of unanticipated adverse device events: estimated to be less than or equal to 5%	30 days

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Tiffany Wu, MD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): August 26, 2020
• Study Completion (ACTUAL): August 26, 2020

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (ACTUAL): March 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TP18-0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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