tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden (RESCUE)
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|ClinicalTrials.gov Identifier: NCT04248868|
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : October 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Device: The Bashir™ Endovascular Catheter Drug: r-tPA||Phase 3|
The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution.
This study will utilize the Bashir™ Endovascular Catheter and the Bashir Endovascular Catheter with a short basket (BASHIR™ S-B endovascular catheter) to administer catheter directed thrombolysis in patients with submassive PE who have consented and meet all eligibility criteria. The Bashir™ and BASHIR™ S-B endovascular catheters represent a new methodology for localized catheter-based delivery of thrombolytics. The thrombolytic to be used in this study is r-tPA (Genentech Corporation, South San Francisco, USA).
The design of the Bashir Endovascular Catheter with the multiple infusion limbs creating a basket-like formation when expanded, provides an immediate channel for blood flow through the thrombus and a greater surface area in the thrombus for the endogenous and exogenous thrombolytics to take effect, as described above.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pulse Spray and Infusion of r-tPA|
|Masking:||None (Open Label)|
|Official Title:||Recombinant tPA by Endovascular Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn|
|Actual Study Start Date :||June 23, 2020|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
Device: The Bashir™ Endovascular Catheter
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Pulse spray and infusion
- Efficacy: RV/LV Ratio Difference [ Time Frame: 48 hours after the completion of r-tPA treatment ]Observe RV/LV diameter ratio difference between baseline and 48 hours after the completion of r-tPA treatment as measured by contrast enhanced chest CT (CTA).
- Safety: Major Bleeding [ Time Frame: Within 72 hours of initiation of r-tPA administration ]
Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients
- Fatal bleeding; and/or
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or
- Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248868
|Contact: Chris Schultz, BSfirstname.lastname@example.org|
|Principal Investigator:||Brian Firth, MD, PhD, MBA, FACC||Thrombolex, Inc.|