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

• ClinicalTrials.gov Identifier: NCT03927508
• Recruitment Status: Completed
• First Posted: April 25, 2019
• Results First Posted: March 30, 2023
• Last Update Posted: March 30, 2023
• Sponsor: Thrombolex, Inc.
• Information provided by (Responsible Party): Thrombolex, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pulmonary Embolism	Drug: r-tPA; Device: The Bashir™ Endovascular Catheter	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pulse Spray and Infusion of r-tPA
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
• Actual Study Start Date: March 14, 2019
• Actual Primary Completion Date: December 19, 2019
• Actual Study Completion Date: January 23, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: BEC Treatment; The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.	Drug: r-tPA; Pulse spray and infusion; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Advent Health Orlando

Orlando, Florida, United States, 32803

United States, Indiana

St Vincent Hospital and Health Care Center, Inc.

Indianapolis, Indiana, United States, 46260

United States, New York

Columbia University Medical Center - Presbyterian - New York

New York, New York, United States, 10032

United States, Pennsylvania

University Pittsburg Medical Center - Hamot

Erie, Pennsylvania, United States, 16507

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

Thrombolex, Inc.

  Study Documents (Full-Text)

Documents provided by Thrombolex, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] September 14, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sista AK, Bhatheja R, Rali P, Natarajan K, Green P, Piazza G, Comerota AJ, Parikh SA, Lakhter V, Bashir R, Rosenfield K. First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism. Circ Cardiovasc Interv. 2021 Jan;14(1):e009611. doi: 10.1161/CIRCINTERVENTIONS.120.009611. Epub 2020 Dec 24.

• Responsible Party: Thrombolex, Inc.
• ClinicalTrials.gov Identifier: NCT03927508
• Other Study ID Numbers: THRO-CLIN-2018-01
• First Posted: April 25, 2019
• Results First Posted: March 30, 2023
• Last Update Posted: March 30, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Thrombolex, Inc.:

Pulmonary Embolism

Additional relevant MeSH terms:

Pulmonary Embolism; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases