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Aspiration Thrombectomy Using the Symphony or Prodigy System

RecruitingN/A

Sponsor: Imperative Care, Inc.

Conditions: Arterial Thromboembolism, Venous Thromboembolism, Pulmonary Embolism

Interventions: Prodigy Thrombectomy System, Symphony Thrombectomy System, Symphony Thrombectomy System

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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
5. Peripheral Venous Cohort ONLY: Presence of thrombus extending more than 2 cm into the IVC on imaging

Locations (8)

Huntsville, Alabama, United States
Tampa, Florida, United States
Naperville, Illinois, United States
Munster, Indiana, United States
Buffalo, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Norfolk, Virginia, United States