RECRUITINGOBSERVATIONAL
Aspiration Thrombectomy Using the Symphony or Prodigy System
Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy System - CLEAR-IT
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form 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
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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
Locations (1)
Huntsville Hospital
Huntsville, Alabama, United States