tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden
(RESCUE Trial)
Recruiting at18 trial locations
BF
Overseen byBrian Firth, MD, PhD, MBA, FACC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Thrombolex, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
BF
Brian Firth, MD, PhD, MBA, FACC
Principal Investigator
Thrombolex, Inc.
Eligibility Criteria
Inclusion Criteria
PE symptom duration ≤ 14 days.
Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT (CTA);
Willing and able to provide informed consent;
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Treatment Details
Interventions
- r-tPA (Thrombolytic Agent)
- The Bashir™ Endovascular Catheter (Device)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BEC TreatmentExperimental Treatment2 Interventions
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thrombolex, Inc.
Lead Sponsor
Trials
3
Recruited
620+
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Trials
3,987
Recruited
47,860,000+
Dr. Gary H. Gibbons
National Heart, Lung, and Blood Institute (NHLBI)
Chief Executive Officer since 2012
MD from Harvard Medical School
Dr. James P. Kiley
National Heart, Lung, and Blood Institute (NHLBI)
Chief Medical Officer since 2011
MD from University of California, San Francisco