Aspiration thrombectomy with the Symphony or Prodigy devices
Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy System - CLEAR-IT
This project will try the Symphony and Prodigy aspiration thrombectomy devices to remove arterial, venous, or pulmonary blood clots in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperative Care, Inc. Industry-sponsored |
| Locations | 1 site (Huntsville, Alabama) |
| Trial ID | NCT07350499 on ClinicalTrials.gov |
What this trial studies
This is an observational study collecting short- and long-term data on the clinical performance and safety of the Symphony and Prodigy thrombectomy systems when used during endovascular procedures in the peripheral or pulmonary vasculature. Adults with a planned procedure using these devices under their intended use are enrolled and followed according to a protocol schedule. Key exclusions include device contraindications, life expectancy under one year, investigator judgment of unsuitability, or inability to complete follow-up. The study is sponsored by Imperative Care, Inc. and is being conducted at Huntsville Hospital in Alabama.
Who should consider this trial
Good fit: Adults (age ≥18) who have a planned endovascular procedure using the Symphony or Prodigy devices for arterial, venous, or pulmonary thromboembolism and can provide consent and complete follow-up are ideal candidates.
Not a fit: Patients with contraindications per the device instructions for use, a life expectancy under one year, or judged unsuitable by the investigator are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the devices may provide a safe and effective way to remove clots, improving blood flow and reducing symptoms or complications from thromboembolism.
How similar studies have performed: Aspiration thrombectomy approaches have been used previously for pulmonary and peripheral clots with varying results, but device-specific outcome data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Huntsville, Alabama
- Huntsville Hospital — Huntsville, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Steven Abramowitz, MD — Medstar Health Research Institute
- Study coordinator: Sylvie Akiel-Fu, MPH
- Email: safu@imperativecare.com
- Phone: 917-375-4735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.