Recruiting NCT07350499
Aspiration Thrombectomy Using the Symphony or Prodigy System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prodigy Thrombectomy System, Symphony Thrombectomy System, Symphony Thrombectomy System.
- Who it may be relevant to
- Registry conditions: Arterial Thromboembolism, Venous Thromboembolism, Pulmonary Embolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy System - CLEAR-IT
Overview
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.
Interventions
- Device Prodigy Thrombectomy System
Removal of thrombus/emboli from blood vessels in the peripheral vasculature - Device Symphony Thrombectomy System
Removal of thrombus/emboli from blood vessels in the peripheral vasculature - Device Symphony Thrombectomy System
Removal of thrombus/emboli from the pulmonary vasculature
Primary outcome measures
- Peripheral Arterial Cohort [Time frame: 30 days]
- Peripheral Venous Cohort [Time frame: 30 days]
- Pulmonary Embolism (PE) Cohort [Time frame: 30 Days]
Secondary outcome measures (12)
- Peripheral Arterial Cohort [Time frame: 90 Days]
- Peripheral Arterial Cohort [Time frame: 180 Days]
- Peripheral Arterial Cohort [Time frame: 30 Days]
- Peripheral Arterial Cohort [Time frame: 90 Days]
- Peripheral Arterial Cohort [Time frame: 180 Days]
- Peripheral Arterial Cohort [Time frame: 30 Days]
- Peripheral Arterial Cohort [Time frame: 90 Days]
- Peripheral Arterial Cohort [Time frame: 180 Days]
- Peripheral Arterial Cohort [Time frame: 30 Days]
- Peripheral Arterial Cohort [Time frame: 90 Days]
- Peripheral Arterial Cohort [Time frame: 180 Days]
- Peripheral Arterial Cohort [Time frame: 30 Days]
Eligibility criteria
Inclusion criteria
- Subject is ≥ 18 years of age
- Subject is willing and able to comply with the follow-up schedule specified in this protocol
- Subject is willing and able to provide written informed consent prior to any study-related data collection
- Subject has a planned procedure, involving the use of Imperative Care vascular devices within their intended use
Exclusion criteria
- Subjects with any contraindications per the applicable Instructions for Use
- Subject with life expectancy of less than 1 year
- In the opinion of the Investigator, the patient is not a suitable candidate for intervention with Imperative Care devices
- Subject who may be unable to complete study follow-up
- Peripheral Venous Cohort ONLY: Presence of thrombus extending more than 2 cm into the IVC on imaging
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 8 centers
- Huntsville Hospital — Huntsville
- BayCare Health - St. Joseph Hospital — Tampa
- Midwest Cardiovascular Institute — Naperville
- Profound Research — Munster
- University At Buffalo — Buffalo
- Mount Sinai Hospital — New York
- Mercy Health — Cincinnati
- Sentara Norfolk General Hospital — Norfolk
Identifiers
NCT: NCT07350499 · ICI-2025-002