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

NCT03927508 | Completed Phase 1 Results DMC FDA Drug FDA Device

• 1 other identifier: THRO-CLIN-2018-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Safety: Number of Participants With Major Bleeding Events

  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.

  Within 72 hours of initiation of r-tPA administration.

Study Arms (1)

BEC Treatment

EXPERIMENTAL

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

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

Interventions

r-tPA DRUG

Pulse spray and infusion

BEC Treatment

The Bashir™ Endovascular Catheter DEVICE

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

BEC Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent;
• 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.

You may not qualify if:

• 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;
• Serum creatinine \> 2 mg/dL;
• Clinician deems high-risk for catastrophic bleeding;
• History of heparin-induced thrombocytopenia (HIT);
• Pregnancy;
• Systolic blood pressure \< 90 mmHg for \> 15 minutes;

Sponsors & Collaborators

• Thrombolex, Inc.: lead

Study Sites (5)

Advent Health Orlando

Orlando, Florida, 32803, United States

Location

St Vincent Hospital and Health Care Center, Inc.

Indianapolis, Indiana, 46260, United States

Location

Columbia University Medical Center - Presbyterian - New York

New York, New York, 10032, United States

Location

University Pittsburg Medical Center - Hamot

Erie, Pennsylvania, 16507, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

• 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.

  PMID: 33356383 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pamela Dicamillo
• Organization: Clinical Reserach Specialist

pdicamillo@ecr-inc.com

719-400-7463

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pulse Spray and Infusion of r-tPA

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: March 14, 2019
• Primary Completion: December 19, 2019
• Study Completion: January 23, 2020
• Last Updated: March 30, 2023
• Results First Posted: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)