CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

Observational Study Clinical Trial

Official title:

CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03869645
• Other study ID #: TP18-0009
• Status: Terminated
• Start date: June 1, 2019
• Est. completion date: August 26, 2020

Study information

• Verified date: September 2022
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: August 26, 2020
• Est. primary completion date: August 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Observational Study

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Memorial Health Services	Fountain Valley	California
United States	St. Joseph Hospital	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

Outcome

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