At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 109 enrolled
Drug / intervention
r-tPA +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Recombinant tPA by Endovascular Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn
In Brief
A Phase 3 clinical trial evaluating The Bashir™ Endovascular Catheter and r-tPA for Pulmonary Embolism. Completed, enrolled 109 participants across 19 sites.
Detailed Summary
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Embolism
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartJun 2020
Primary CompletionJun 2022
Study CompletionJun 2022
TodayJul 2026
First PostedJan 30, 2020
Enrollment StartJun 23, 2020
Primary CompletionJun 22, 2022
Study CompletionJun 23, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.4 years ago
Interventions
The Bashir™ Endovascular Catheterdevice
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
r-tPAdrug
Pulse spray and infusion