First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism

Thrombolex

Status and phase: Completed; Phase 1

Conditions: Pulmonary Embolism

Treatments: Device: The Bashir™ Endovascular Catheter; Drug: r-tPA

Study type: Interventional

Funder types: Industry

Identifiers

NCT03927508

THRO-CLIN-2018-01

Details and patient eligibility

About

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

General Inclusion Criteria:

1. Willing and able to provide informed consent;
2. 18 years of age and less than 75 years of age;
3. PE symptom duration ≤ 14 days;
4. Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT;
5. RV/LV end diastolic diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
6. Willing and able to comply with all study procedures and follow-up.

Exclusion criteria

1. Cerebrovascular Accident (CVA) or transient ischemic attack (TIA) within one (1) year;
2. Head trauma, or other active intracranial, or intraspinal disease within one (1) year;
3. Recent (within one month) or active bleeding from a major organ;
4. Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
5. Patients with bleeding diathesis;
6. Hematocrit < 30%;
7. Platelets < 100,000/μL;
8. INR > 1.5;
9. aPTT > 50 seconds in the absence of anticoagulants;
10. Major surgery within fourteen (14) days;
11. Serum creatinine > 2 mg/dL;
12. Clinician deems high-risk for catastrophic bleeding;
13. History of heparin-induced thrombocytopenia (HIT);
14. Pregnancy;
15. Systolic blood pressure < 90 mmHg for > 15 minutes;
16. Any vasopressor support;
17. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR);
18. Evidence of irreversible neurological compromise;
19. Life expectancy < one (1) year;
20. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study;
21. Use of non-vitamin K oral anti-coagulants (NOACs), such as Rivaroxaban, Apixaban, Dabigatran, Edoxaban within 48 hours prior to inclusion in the study;
22. Use of enoxaparin sodium injection (Lovenox®) within 12 hours of procedure start time;
23. Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
24. Previous enrollment in this study;
25. Morbidly obese (BMI >45 kg/m2) patient who by the judgement of the investigator is high risk for bleeding;
26. Absolute contraindication to anticoagulation;
27. Uncontrolled hypertension;
28. Currently participating in another study;
29. In the opinion of the investigator, the subject is not a suitable candidate for the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

BEC Treatment

Experimental group

Description:

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.

Treatment:

Device: The Bashir™ Endovascular Catheter

Drug: r-tPA