Aspiration Thrombectomy Using the Symphony or Prodigy System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperative Care, Inc.
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prodigy Thrombectomy System
- Symphony Thrombectomy System
- Symphony Thrombectomy System
Treatment groups
750 Participants
are divided into 3 treatment groupsLocations
4Huntsville Hospital35801, HuntsvilleAlabama, United States
BayCare Health - St. Joseph Hospital33607, TampaFlorida, United States
Profound Research46321, MunsterIllinois, United States
Mercy Health45242, CincinnatiOhio, United States
Sponsors and collaborators
Imperative Care, Inc.
Lead sponsor
Source ClinicalTrials.gov