Aspirationstrombektomi ved brug af Symphony- eller Prodigy-systemet (CLEAR-IT)
Langtids Klinisk Evaluering af Aspirationstrombektomi ved Brug af Symphony eller ProdIgy Trombektomisystemet - CLEAR-IT
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Sylvie Akiel-Fu, MPH
- Telefonnummer: 917-375-4735
- E-mail: safu@imperativecare.com
Studiesteder
-
-
Alabama
-
Huntsville, Alabama, Forenede Stater, 35801
- Rekruttering
- Huntsville Hospital
-
-
Florida
-
Clearwater, Florida, Forenede Stater, 33756
- Rekruttering
- BayCare Health System- Morton Plant Hospital
-
Jacksonville, Florida, Forenede Stater, 32216
- Rekruttering
- HCA Florida Memorial Hospital
-
Tampa, Florida, Forenede Stater, 33607
- Rekruttering
- BayCare Health System - St. Joseph Hospital
-
-
Illinois
-
Naperville, Illinois, Forenede Stater, 60540
- Rekruttering
- Midwest Cardiovascular Institute
-
-
Indiana
-
Munster, Indiana, Forenede Stater, 46321
- Rekruttering
- Profound Research
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48202
- Rekruttering
- Henry Ford Hospital
-
-
New York
-
Buffalo, New York, Forenede Stater, 14203
- Rekruttering
- University At Buffalo
-
New York, New York, Forenede Stater, 10029
- Rekruttering
- Mount Sinai Hospital
-
-
North Carolina
-
Raleigh, North Carolina, Forenede Stater, 27607
- Rekruttering
- NC Heart and Vascular Research
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45242
- Rekruttering
- Mercy Health
-
-
Texas
-
Fort Worth, Texas, Forenede Stater, 761104
- Rekruttering
- Medical City Fort Worth Hospital
-
-
Virginia
-
Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Sentara Norfolk General Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Peripheral Arterial
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature |
Removal of thrombus/emboli from blood vessels in the peripheral vasculature |
|
Peripheral Venous
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature |
Removal of thrombus/emboli from blood vessels in the peripheral vasculature Removal of thrombus/emboli from the pulmonary vasculature |
|
Pulmonary Embolism
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature |
Removal of thrombus/emboli from blood vessels in the peripheral vasculature Removal of thrombus/emboli from the pulmonary vasculature |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peripheral Arterial Cohort
Tidsramme: 30 days
|
Freedom from major (above-ankle) unanticipated amputation of the index limb |
30 days
|
|
Peripheral Venous Cohort
Tidsramme: 30 days
|
Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline. |
30 days
|
|
Pulmonary Embolism (PE) Cohort
Tidsramme: 30 Days
|
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. |
30 Days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peripheral Arterial Cohort
Tidsramme: 90 Days
|
Freedom from major (above-ankle) amputation of the index limb |
90 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 180 Days
|
Freedom from major (above-ankle) amputation of the index limb |
180 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 30 Days
|
Major adverse cardiovascular events (MACE) rate |
30 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 90 Days
|
Major adverse cardiovascular events (MACE) rate |
90 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 180 Days
|
Major adverse cardiovascular events (MACE) rate |
180 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 30 Days
|
Target vessel patency assessed using change in ankle-brachial index |
30 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 90 Days
|
Target vessel patency assessed using change in ankle-brachial index |
90 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 180 Days
|
Target vessel patency assessed using change in ankle-brachial index |
180 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 30 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
30 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 90 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
90 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 180 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
180 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 30 Days
|
Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management |
30 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 90 Days
|
Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management |
90 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 180 Days
|
Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management |
180 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 90 Days
|
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) |
90 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 180 Days
|
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) |
180 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 30 Days
|
All-cause mortality |
30 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 90 Days
|
All-cause mortality |
90 Days
|
|
Peripheral Arterial Cohort
Tidsramme: 180 Days
|
All-cause mortality |
180 Days
|
|
Peripheral Venous Cohort
Tidsramme: Intraprocedural
|
Technical success defined as complete or near complete (>75%) reduction in Marder score from baseline to immediately after the use of the device and prior to any use of adjunctive device, as independently adjudicated |
Intraprocedural
|
|
Peripheral Venous Cohort
Tidsramme: 48 hours
|
Rate of Major Adverse Events (MAEs) as adjudicated by an independent medical monitor and defined as the occurrence of any of the following:
|
48 hours
|
|
Peripheral Venous Cohort
Tidsramme: 90
|
Treated limb improvement at 90 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline |
90
|
|
Peripheral Venous Cohort
Tidsramme: 180
|
Treated limb improvement at 180 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline |
180
|
|
Peripheral Venous Cohort
Tidsramme: 30 Days
|
Proportion of patients demonstrating decrease in Villalta score (A decrease in Villalta score reflects an improvement per the following scale: 0-4 - no disease; 5-9: mild disease; 10-14: moderate disease; 15 or > : severe disease) |
30 Days
|
|
Peripheral Venous Cohort
Tidsramme: 90 Days
|
Proportion of patients demonstrating decrease in Villalta score |
90 Days
|
|
Peripheral Venous Cohort
Tidsramme: 180 Days
|
Proportion of patients demonstrating decrease in Villalta score |
180 Days
|
|
Peripheral Venous Cohort
Tidsramme: 30 Days
|
Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure. |
30 Days
|
|
Peripheral Venous Cohort
Tidsramme: 60 Days
|
Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure. |
60 Days
|
|
Peripheral Venous Cohort
Tidsramme: 180 Days
|
Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure. |
180 Days
|
|
Peripheral Venous Cohort
Tidsramme: 180 Days
|
Quality of life and symptom severity assessment using the Venous Insufficiency Epidemiological and Economic Study (VEINES -QOL); higher scores indicate better quality of life/fewer symptoms |
180 Days
|
|
Peripheral Venous Cohort
Tidsramme: 30 Days
|
All-cause mortality |
30 Days
|
|
Peripheral Venous Cohort
Tidsramme: 90 Days
|
All-cause mortality |
90 Days
|
|
Peripheral Venous Cohort
Tidsramme: 180 Days
|
All-cause mortality |
180 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: Intraprocedural
|
Change in pulmonary artery pressure |
Intraprocedural
|
|
Pulmonary Embolism Cohort
Tidsramme: 48 hours
|
Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Tidsramme: 48 hours
|
Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Tidsramme: 30 Days
|
Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated |
30 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 48 hours
|
Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Tidsramme: 30 Days
|
Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated |
30 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 48 hours
|
Rate of Major Adverse Events (MAEs) as adjudicated by an independent medical monitor and defined as the occurrence of any of the following:
|
48 hours
|
|
Pulmonary Embolism Cohort
Tidsramme: 30 days
|
Right ventricle to left ventricle (RV/LV) ratio reduction from baseline |
30 days
|
|
Pulmonary Embolism Cohort
Tidsramme: 90 Days
|
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class |
90 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 180 Days
|
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class |
180 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 30 Days
|
Pulmonary Embolism recurrence |
30 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 90 Days
|
Pulmonary Embolism recurrence |
90 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 180 Days
|
Pulmonary Embolism recurrence |
180 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 30 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
30 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 90 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
90 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 180 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
180 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 30 Days
|
All-cause mortality |
30 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 90 Days
|
All-cause mortality |
90 Days
|
|
Pulmonary Embolism Cohort
Tidsramme: 180 Days
|
All-cause mortality |
180 Days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Steven Abramowitz, MD, Medstar Health Research Institute
- Ledende efterforsker: Maya Serhal, MD, Massachusetts General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ICI-2025-002
Plan for individuelle deltagerdata (IPD)
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