Aspiration Thrombectomy Using the Symphony or Prodigy System (CLEAR-IT)

Imperative Care

Status: Not yet enrolling

Conditions: Pulmonary Embolism; Venous Thromboembolism; Arterial Thromboembolism

Treatments: Device: Prodigy Thrombectomy System; Device: Symphony Thrombectomy System

Study type: Observational

Funder types: Industry

Identifiers

NCT07350499

ICI-2025-002

Details and patient eligibility

About

The study is designed to evaluate the short-term and long-term clinical performance and safety of the Symphony and Prodigy thrombectomy systems used in endovascular procedures across the peripheral or pulmonary vasculature.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is ≥ 18 years of age
2. Subject is willing and able to comply with the follow-up schedule specified in this protocol
3. Subject is willing and able to provide written informed consent prior to any study-related data collection
4. Subject has a planned procedure, involving the use of Imperative Care vascular devices within their intended use

Exclusion criteria

1. Subjects with any contraindications per the applicable Instructions for Use
2. Subject with life expectancy of less than 1 year
3. In the opinion of the Investigator, the patient is not a suitable candidate for intervention with Imperative Care devices
4. Subject who may be unable to complete study follow-up

Trial design

750 participants in 3 patient groups

Peripheral Arterial

Description:

Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature

Treatment:

Device: Prodigy Thrombectomy System

Peripheral Venous

Description:

Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature

Treatment:

Device: Symphony Thrombectomy System

Device: Symphony Thrombectomy System

Pulmonary Embolism

Description:

Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature

Treatment:

Device: Symphony Thrombectomy System

Device: Symphony Thrombectomy System