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
This trial does not accept healthy volunteersQualifiers
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 population
The study will enroll subjects aged 18 years and older who are undergoing endovascular procedures in the peripheral or pulmonary vasculature systems where, in the opinion of the treating physician, Imperative Care devices are appropriate for use within their cleared indications. All subjects must meet the general eligibility criteria and provide written informed consent prior to any study-specific data collection.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Prodigy Thrombectomy System
DeviceRemoval of thrombus/emboli from blood vessels in the peripheral vasculature
Symphony Thrombectomy System
DeviceRemoval of thrombus/emboli from blood vessels in the peripheral vasculature
Symphony Thrombectomy System
DeviceRemoval of thrombus/emboli from the pulmonary vasculature
Treatment groups
750 Participants
are divided into 3 treatment groupsGroup A: Peripheral Arterial1 intervention
Group B: Peripheral Venous1 intervention
Group C: Pulmonary Embolism1 intervention
Trial outcomes
Primary outcomes
1
Peripheral Arterial Cohort
Freedom from major (above-ankle) unanticipated amputation of the index limb
Time frame
30 days2
Peripheral Venous Cohort
Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline.
Time frame
30 days3
Pulmonary Embolism (PE) Cohort
Normal right ventricular function at 30 days follow-up, defined as tricuspid annular plane systolic excursion (TAPSE) \>1.7cm , measured on transthoracic echocardiography (TTE) and independently adjudicated.
Time frame
30 DaysSecondary outcomes
1
Peripheral Arterial Cohort
Freedom from major (above-ankle) amputation of the index limb
Time frame
90 Days2
Peripheral Arterial Cohort
Freedom from major (above-ankle) amputation of the index limb
Time frame
180 Days3
Peripheral Arterial Cohort
Major adverse cardiovascular events (MACE) rate
Time frame
30 Days4
Peripheral Arterial Cohort
Major adverse cardiovascular events (MACE) rate
Time frame
90 DaysSponsors and contacts
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Source ClinicalTrials.gov