CAPERE Thrombectomy System Post-Market Clinical Follow Up Study

Medtronic

Status: Terminated

Conditions: Observational Study

Treatments: Device: CAPERE Thrombectomy System

Study type: Observational

Funder types: Industry

Identifiers

NCT03869645

TP18-0009

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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