Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Brief Title:
Augmented Ultrasound-Facilitated Catheter-Directed Fibrinolysis for PE
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Prospective Single-Arm Multicenter Study of Augmented Ultrasound-Facilitated Catheter-Directed Low-Dose Fibrinolysis for Pulmonary Embolism SONIC-PE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SONIC-PE
Brief Summary:
SONIC-PE is a multicenter prospective single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated catheter-directed lower-dose fibrinolysis total dose 8 mg tPA given as 2 mghourcatheter over 2 hours followed by 50 patients total dose 6 mg tPA given as 3 mghourcatheter given over 1 hour with the EKOS system to determine its impact on the change in RV-to-LV diameter refined Modified Miller Score and distal pulmonary vascular blood volume as well as to assess International Society on Thrombosis and Haemostasis ISTH major bleeding
Detailed Description:
Patients with intermediate-high risk pulmonary embolism PE comprise a population at increased risk for clinical deterioration despite initially stable hemodynamics The pathophysiology of hemodynamic deterioration in intermediate-high risk PE includes an abrupt increase in pulmonary vascular resistance due to proximal as well as distal pulmonary artery occlusion pulmonary hypertension right ventricular RV pressure overload and ultimately RV failure While full-dose systemic fibrinolysis for PE has demonstrated efficacy for prevention of early morbidity and mortality its net clinical benefit is attenuated by the risk of major bleeding in particular intracranial hemorrhage Catheter-directed therapies have been demonstrated to facilitate RV recovery while reducing the risk of major bleeding through use of lower-dose fibrinolysis or avoiding it altogether Specifically lower-dose regimens for ultrasound-facilitated catheter-directed fibrinolysis result in sustained recovery of echocardiographically-determined RV function reduction in Modified Miller Score large-vessel pulmonary angiographic obstruction functional status and quality of life over the year following ultrasound-facilitated catheter-directed fibrinolysis
Recently an upgrade to the output of the ultrasonic core catheter of the EKOS Endovascular System EKOS has demonstrated the ability to enhance fibrinolysis within a lower fibrinolytic dose range in preliminary studies Boston Scientific Corporation Maple Grove MN Compared with current EkoSonic system a 50 increase in ultrasound power measured in watts with EKOS resulted in a 130 increase in in vitro clot lysis compared with conventional catheter-directed fibrinolysis using the same dose of fibrinolytic drug
SONIC-PE is multicenter prospective single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated catheter-directed lower-dose fibrinolysis total dose 8 mg tPA given as 2 mghourcatheter over 2 hours followed by 50 patients total dose 6 mg tPA given as 3 mghourcatheter given over 1 hour with the EKOS system to determine its impact on the change in RV-to-LV diameter refined Modified Miller Score and distal pulmonary vascular blood volume as well as assess International Society on Thrombosis and Haemostasis ISTH major bleeding The study will have an adaptive design component with transition to 8 mg tPA2 hours if there is an excess of bleeding or observed lack of efficacy as determined by an Independent Study Safety Monitor
Recently an upgrade to the output of the ultrasonic core catheter of the EKOS Endovascular System EKOS has demonstrated the ability to enhance fibrinolysis within a lower fibrinolytic dose range in preliminary studies Boston Scientific Corporation Maple Grove MN Compared with current EkoSonic system a 50 increase in ultrasound power measured in watts with EKOS resulted in a 130 increase in in vitro clot lysis compared with conventional catheter-directed fibrinolysis using the same dose of fibrinolytic drug
SONIC-PE is multicenter prospective single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated catheter-directed lower-dose fibrinolysis total dose 8 mg tPA given as 2 mghourcatheter over 2 hours followed by 50 patients total dose 6 mg tPA given as 3 mghourcatheter given over 1 hour with the EKOS system to determine its impact on the change in RV-to-LV diameter refined Modified Miller Score and distal pulmonary vascular blood volume as well as assess International Society on Thrombosis and Haemostasis ISTH major bleeding The study will have an adaptive design component with transition to 8 mg tPA2 hours if there is an excess of bleeding or observed lack of efficacy as determined by an Independent Study Safety Monitor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None