CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

Terminated

• Conditions: Observational Study

• Registration Number: NCT03869645
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-06-01
• Primary Completion: 2020-08-26
• Study Completion: 2020-08-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Restoration of blood flow	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

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

Trial Locations

Locations (3)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Memorial Health Services; 🇺🇸 Fountain Valley, California, United States

St. Joseph Hospital; 🇺🇸 Orange, California, United States