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New treatment option for Pulmonary Embolism
Official title The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
ClinicalTrials.gov ID: NCT06433011
What this study is testing
What is r-tPA?
r-tPA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pulmonary embolism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility criteria
- 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.
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Tuscon, Arizona, United States
- Lakeland, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Hobart, Indiana, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- Tupelo, Mississippi, United States
- Lebanon, New Hampshire, United States
- Camden, New Jersey, United States
- Liverpool, New York, United States
- Manhasset, New York, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Dayton, Ohio, United States
- Toledo, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Tuscon, Arizona, United States; Lakeland, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Hobart, Indiana, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.