First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
Overview
- Phase
- Phase 1
- Intervention
- r-tPA
- Conditions
- Pulmonary Embolism
- Sponsor
- Thrombolex, Inc.
- Enrollment
- 9
- Locations
- 5
- Primary Endpoint
- Safety: Number of Participants With Major Bleeding Events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General Inclusion Criteria:
- •Willing and able to provide informed consent;
- •18 years of age and less than 75 years of age;
- •PE symptom duration ≤ 14 days;
- •Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT;
- •RV/LV end diastolic diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
- •Willing and able to comply with all study procedures and follow-up.
Exclusion Criteria
- •Cerebrovascular Accident (CVA) or transient ischemic attack (TIA) within one (1) year;
- •Head trauma, or other active intracranial, or intraspinal disease within one (1) year;
- •Recent (within one month) or active bleeding from a major organ;
- •Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- •Patients with bleeding diathesis;
- •Hematocrit \< 30%;
- •Platelets \< 100,000/μL;
- •INR \> 1.5;
- •aPTT \> 50 seconds in the absence of anticoagulants;
- •Major surgery within fourteen (14) days;
Arms & Interventions
BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
Intervention: r-tPA
BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
Intervention: The Bashir™ Endovascular Catheter
Outcomes
Primary Outcomes
Safety: Number of Participants With Major Bleeding Events
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 1. Fatal bleeding; and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or 3. 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.