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Recruiting
NCT07350499
Aspiration Thrombectomy Using the Symphony or Prodigy System
Conditions: Arterial Thromboembolism, Venous Thromboembolism, Pulmonary Embolism
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 750
Sponsor: Imperative Care, Inc.
Location: Huntsville Hospital Huntsville Alabama
Summary
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 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
Source: ClinicalTrials.gov (NCT07350499). StuddyBuddy aggregates publicly available trial information.