Trial Outcomes & Findings for First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism (NCT NCT03927508)

Last Updated: 2023-03-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

Within 72 hours of initiation of r-tPA administration.

Results posted on

2023-03-30

Participant Flow

Enrollment took place over a period of four (4) months, July 19, 2019 - November 16, 2019. The date the study is was open for recruitment started March 14, 2019. Study was FDA approved for up to five (5) sites. Nine (9) subjects were enrolled and are included in this report through 30-day follow-up.

Participant milestones

Participant milestones
Measure	BEC Treatment The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. r-tPA: Pulse spray and infusion 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.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BEC Treatment n=9 Participants The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. r-tPA: Pulse spray and infusion 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.67 years STANDARD_DEVIATION 11.64 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 72 hours of initiation of r-tPA administration.

Outcome measures

Outcome measures
Measure	BEC Treatment n=9 Participants The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. r-tPA: Pulse spray and infusion 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.
Safety: Number of Participants With Major Bleeding Events	1 Participants

Adverse Events

BEC Treatment

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BEC Treatment n=9 participants at risk The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. r-tPA: Pulse spray and infusion 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.
Vascular disorders Hematoma	11.1% 1/9 • Number of events 1 • From treatment through 30 days

Other adverse events

Other adverse events
Measure	BEC Treatment n=9 participants at risk The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. r-tPA: Pulse spray and infusion 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.
General disorders Pain	22.2% 2/9 • Number of events 2 • From treatment through 30 days
General disorders Tenderness	22.2% 2/9 • Number of events 2 • From treatment through 30 days
General disorders Injection site pain	11.1% 1/9 • Number of events 1 • From treatment through 30 days
Investigations occult blood	11.1% 1/9 • Number of events 1 • From treatment through 30 days
Injury, poisoning and procedural complications tooth injury	11.1% 1/9 • Number of events 1 • From treatment through 30 days
Nervous system disorders Hypoaesthia	11.1% 1/9 • Number of events 1 • From treatment through 30 days
Respiratory, thoracic and mediastinal disorders Bronchial wall thickening	11.1% 1/9 • Number of events 1 • From treatment through 30 days
General disorders Odema peripheral	11.1% 1/9 • Number of events 1 • From treatment through 30 days

Additional Information

Pamela Dicamillo

Clinical Reserach Specialist

Phone: 719-400-7463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place