Pulmonary EmbolismNCT06433011
The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
A study testing The Bashir™ Endovascular Catheter and r-tPA in people with Pulmonary Embolism, run by Thrombolex, Inc. at 23 sites in United States.
Trial summary
To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- The Bashir™ Endovascular Catheter and r-tPA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 23 sitesUnited States
- Study dates
- 17 Oct 2024to 25 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent;
- PE symptom duration ≤ 15 days;
- Filling defect in at least one major lobar pulmonary artery as determined by CTA;
- Patient is diagnosed with intermediate risk PE;
- RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site;
- Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit.
Who cannot join
- Previous history of stroke with residual hemiplegia;
- Major surgery ≤ 10 days prior to inclusion in the study;
- Platelet count < 100,000/μL;
- Pulmonary thrombectomy within the previous 4 days;
- Uncontrolled hypertension defined as systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at the time of the procedure;
- Administration of thrombolytic agents within the previous 4 days;
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- Absolute contraindication to anticoagulation;
- Clinician deems high-risk for catastrophic bleeding;
- Pregnancy;
- Any vasopressor or inotropic support;
- Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
- Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays;
- Currently participating in another study;
- In the opinion of the investigator, the subject is not a suitable candidate for the study.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 23 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30308
Pratik Sandesara, 404-686-7468
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02135
Tariq Bhat, 617-779-6731
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02481
Jeffrey Weinstein, 617-754-2523
- Recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Michael Levy, 781-744-8460
- Recruiting
Cooper Health
Camden, New Jersey, 08103
Elias Iliadis, 856-757-7832
- Recruiting
Charleston Area Medical Center
Charleston, West Virginia, 25304
Mohammad Eslami, 304-388-5432
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Bulent Arslan, 434-242-8364
- Recruiting
TriHealth
Cincinnati, Ohio, 45242
Adam Reichard, 513-865-9898
- Recruiting
Miami Valley/Wright State University/Premier Health
Dayton, Ohio, 45435
Ryan Brandt, 937-208-3689
- Recruiting
Profound Research
Hobart, Indiana, 46342
Anas Safadi
- Recruiting
Community Health
Indianapolis, Indiana, 46256
Michael Robertson, 317-621-7724
- Recruiting
Radiology and Imaging Specialists
Lakeland, Florida, 33801
Kurt Gordon, "863-688-2334 ext. 135
- Recruiting
Dartmouth Hitchcock
Lebanon, New Hampshire, 03756
Michael Young, 615-927-9043
- Recruiting
St. Joseph's
Liverpool, New York, 13088
Ayman Iskander, 315-234-4412
- Recruiting
Northwell Health
Manhasset, New York, 11030
Vincent Gallo, 718-226-6422
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Alexander Sullivan, 615-343-8647
- Recruiting
Mount Sinai
New York, New York, 10029
Jenanan Vairavamurthy, 212-659-9151
- Recruiting
Sentara
Norfolk, Virginia, 23507
David Dexter, 757-395-1600
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Parth Rali, 215-707-1359
- Recruiting
Honor Health
Scottsdale, Arizona, 85258
Chintan Patel, 480-323-1046
- Recruiting
Jobst Vascular Institute - ProMedica Hospital
Toledo, Ohio, 43606
Ahmad Younes, 419-291-2111
- Recruiting
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Barry Bertolet, 662-213-0405
- Recruiting
Carondelet St. Joseph's Hospital
Tuscon, Arizona, 85711
Sundeep Shenoy, 520-873-1591
About this study
Official title: The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism
To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).
Read the detailed description
The BASHIR™ .035 Endovascular Catheter (BEC) and the BEC Short Basket .035 (S-B) are devices intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The distal infusion segment of the device contains an expandable radial array of conduits with a total of 48 laser drilled orifices used for the delivery of the therapeutic agents at multiple cross-sectional points of the target vessel location. The infusion segment can be expanded and collapsed by the actuator (slider) located on the handle at the proximal end of the device. The infusion line connector is also located on the handle. The difference between the BEC .035 and the BEC S-B.035 is solely in the length of the basket. In its unexpanded state, the basket of the BEC .035 is 12.5cm long and the BEC S-B .035 basket is 10cm long. The choice of device used will be at the physician's discretion based on the patient's anatomy.
- Conditions
- Pulmonary Embolism
- Being tested
- The Bashir™ Endovascular Catheter, r-tPA
- Keywords
- Pulmonary Embolism, Catheter Directed Therapy
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| BEC Treatment | Experimental | The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. Receives: Device: The Bashir™ Endovascular Catheter; Drug: r-tPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Death from any cause or hemodynamic decompensation (or collapse)
Observe death from any cause or hemodynamic decompensation (or collapse) through 7-day follow-up, defined as need for cardiopulmonary resuscitation; or
- SBP < 90 mmHg for at least 15 minutes; or
- drop in SBP by at least 40 mmHg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output < 30 mL/h or mental confusion); or
- need for catecholamine administration to maintain adequate organ perfusion and a SBP > 90 mmHg (including dopamine at the rate of > 5 micrograms / kg per minute).
Measured: Procedure through 7-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start17 Oct 2024
- Primary completion25 Apr 2028 (estimated)
- Study completion25 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Pulse Spray and Infusion of r-tPA
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thrombolex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Stephens, Study director, Thrombolex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433011
- Sponsor's protocol ID
- THRO-CLIN-2024-01
- Status last verified
- Jul 2026
- First submitted
- 22 May 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06433011
- Acronym / sponsor ID
- THRO-CLIN-2024-01
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Catheter Directed Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Thrombolex, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 25 Apr 2028 (estimated)
- Study completion
- 25 Apr 2028 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).
Detailed description
The BASHIR™ .035 Endovascular Catheter (BEC) and the BEC Short Basket .035 (S-B) are devices intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The distal infusion segment of the device contains an expandable radial array of conduits with a total of 48 laser drilled orifices used for the delivery of the therapeutic agents at multiple cross-sectional points of the target vessel location. The infusion segment can be expanded and collapsed by the actuator (slider) located on the handle at the proximal end of the device. The infusion line connector is also located on the handle. The difference between the BEC .035 and the BEC S-B.035 is solely in the length of the basket. In its unexpanded state, the basket of the BEC .035 is 12.5cm long and the BEC S-B .035 basket is 10cm long. The choice of device used will be at the physician's discretion based on the patient's anatomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Pulse Spray and Infusion of r-tPA
| Arm | Type | Receives |
|---|---|---|
| BEC Treatment | Experimental | Device: The Bashir™ Endovascular Catheter, Drug: r-tPAThe Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide informed consent;
- PE symptom duration ≤ 15 days;
- Filling defect in at least one major lobar pulmonary artery as determined by CTA;
- Patient is diagnosed with intermediate risk PE;
- RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site;
Key exclusion criteria (14 listed)
- Previous history of stroke with residual hemiplegia;
- Major surgery ≤ 10 days prior to inclusion in the study;
- Platelet count < 100,000/μL;
- Pulmonary thrombectomy within the previous 4 days;
- Uncontrolled hypertension defined as systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at the time of the procedure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Bashir™ Endovascular CatheterThe Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. | Device | BEC Treatment |
| r-tPAPulse spray and infusion | Drug | BEC Treatment |
Primary outcome
Efficacy: Death from any cause or hemodynamic decompensation (or collapse)
Time frame: Procedure through 7-day follow-up
Observe death from any cause or hemodynamic decompensation (or collapse) through 7-day follow-up, defined as need for cardiopulmonary resuscitation; or 1. SBP < 90 mmHg for at least 15 minutes; or 2. drop in SBP by at least 40 mmHg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output < 30 mL/h or mental confusion); or 3. need for catecholamine administration to maintain adequate organ perfusion and a SBP > 90 mmHg (including dopamine at the rate of > 5 micrograms / kg per minute).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Stephens study director
Thrombolex, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Bashir™ Endovascular Catheter and r-tPA in people with Pulmonary Embolism, run by Thrombolex, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Schultz, BS (971-506-7552, cschultz@ecr-inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Death from any cause or hemodynamic decompensation (or collapse) (time frame: Procedure through 7-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.