Trial Outcomes & Findings for tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden (NCT NCT04248868)
NCT ID: NCT04248868
Last Updated: 2023-04-20
Results Overview
Observe RV/LV diameter ratio difference between baseline and 48 hours after the completion of r-tPA treatment as measured by contrast enhanced chest CT (CTA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
109 participants
Primary outcome timeframe
48 hours after the completion of r-tPA treatment
Results posted on
2023-04-20
Participant Flow
Participant milestones
| Measure |
BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
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.
r-tPA: Pulse spray and infusion
|
|---|---|
|
Overall Study
STARTED
|
109
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
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.
r-tPA: Pulse spray and infusion
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden
Baseline characteristics by cohort
| Measure |
BEC Treatment
n=109 Participants
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
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.
r-tPA: Pulse spray and infusion
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 13.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours after the completion of r-tPA treatmentPopulation: Subjects treated with the Bashir™ Endovascular Catheter and had analyzable baseline and 48 hour CTAs.
Observe RV/LV diameter ratio difference between baseline and 48 hours after the completion of r-tPA treatment as measured by contrast enhanced chest CT (CTA).
Outcome measures
| Measure |
BEC Treatment
n=107 Participants
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
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.
r-tPA: Pulse spray and infusion
|
|---|---|
|
Efficacy: RV/LV Ratio Difference
RV/LV Ratio at Baseline (R0)
|
1.66 RV/LV Ratio
Interval 1.58 to 1.75
|
|
Efficacy: RV/LV Ratio Difference
RV/LV Ratio within 48 hours of completion of treatment (R48)
|
1.10 RV/LV Ratio
Interval 1.06 to 1.15
|
|
Efficacy: RV/LV Ratio Difference
Difference (R48-R0)
|
-0.56 RV/LV Ratio
Interval -0.64 to -0.48
|
PRIMARY outcome
Timeframe: Within 72 hours of initiation of r-tPA administrationPopulation: Subjects treated with the Bashir™ Endovascular Catheter
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.
Outcome measures
| Measure |
BEC Treatment
n=109 Participants
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
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.
r-tPA: Pulse spray and infusion
|
|---|---|
|
Safety: Major Bleeding
|
1 Participants
|
Adverse Events
BEC Treatment
Serious events: 7 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BEC Treatment
n=109 participants at risk
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
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.
r-tPA: Pulse spray and infusion
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Immune system disorders
Hypersensitivity
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Vascular disorders
Embolism
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Infections and infestations
Abscess limb
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Infections and infestations
Sepsis
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Renal and urinary disorders
Acute kidney injury
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
2/109 • Number of events 2 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Vascular disorders
Haematoma
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
General disorders
Alcohol withdrawal syndrom
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
Other adverse events
| Measure |
BEC Treatment
n=109 participants at risk
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
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.
r-tPA: Pulse spray and infusion
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Product Issues
Device operational issue
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Nervous system disorders
Insomnia
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Investigations
Blood urine present
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Vascular disorders
Haematuria
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
General disorders
Oedema peripheral
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Infections and infestations
Vascular access site infection
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
General disorders
Fever
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Blood and lymphatic system disorders
Arrhythmia
|
1.8%
2/109 • Number of events 2 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Nervous system disorders
Fasciculation
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Infections and infestations
Abscesses of skin
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infarct
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
General disorders
Pain
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
General disorders
Tenderness
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.92%
1/109 • Number of events 1 • Adverse event data was captured from time of the procedure through 30-day follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60