Acute Submassive Pulmonary EmbolismNCT06120179
The RESCUE II Study. The Bashir™ Endovascular Catheter (BEC),
A study testing The Bashir™ Endovascular Catheter (BEC in people with Acute Submassive Pulmonary Embolism, run by Temple University at 1 site in United States.
Trial summary
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse spray of r-tPA for the treatment of acute submassive pulmonary embolism Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Submassive Pulmonary Embolism
- What is being tested?
- The Bashir™ Endovascular Catheter (BEC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent;
- Age 18 to ≤ 75 years of age;
- PE symptom duration ≤ 14 days.
- Filling defect in at least one main or lobar pulmonary artery as determined by CTA;
- RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
- Willing and able to comply with all study procedures and follow-up
Who cannot join
- CVA or TIA within one (1) year;
- Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
- Active bleeding from a major organ within one (1) month prior to inclusion in the study;
- Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- Patients with bleeding diatheses;
- Hematocrit < 30%;
Show all 25Show fewer
- Platelets < 100,000/μL;
- INR > 1.5 if currently on warfarin (Coumadin®);
- aPTT > 50 seconds in the absence of anticoagulants;
- Major surgery ≤ 14 days prior to inclusion in the study;
- Serum creatinine > 2.0mg/dL;
- Clinician deems high-risk for catastrophic bleeding;
- History of heparin-induced thrombocytopenia (HIT Syndrome);
- Pregnancy;
- SBP < 90 mmHg > 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
- Any vasopressor support;
- Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
- Evidence of irreversible neurological compromise;
- Life expectancy < one (1) year;
- Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
- Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
- Absolute contraindication to anticoagulation;
- Uncontrolled hypertension defined as SBP > 175mmHg and / or DBP > 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
- 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
1 site in 1 country.
United States1 site
Temple University
Philadelphia, Pennsylvania, 19140
Lauren Miller, BS, 215-707-4821, lauren.e.miller@temple.edu
Michael Jacobs, PharmD, 215-707-2221, Michael.Jacobs@tuhs.temple.edu
About this study
Official title: Recombinant tPA by Endovascular Pulse Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse spray of r-tPA for the treatment of acute submassive pulmonary embolism
Read the detailed description
Study Objective To demonstrate the efficacy and safety of the Bashir™ and Bashir™ S-B Endovascular Catheters for the administration of pharmaco- mechanical catheter directed therapy in a pulse spray mode using low dose r-tPA for the treatment of acute submassive pulmonary embolism. Endpoints Primary Efficacy Endpoint Reduction in RV/LV diameter ratio as measured by CTA within 48 hours after the completion of r-tPA treatment.
Primary Safety Endpoint Major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r- tPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and:
- Fatal bleeding; and/or b. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra- articular or pericardial, or intramuscular with compartment syndrome; and/or c. Bleeding causing a fall in hemoglobin level of 2.0g/dL (1.24mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells. Secondary Endpoints
- Refined Modified Miller Score as measured on CTA within 48 hours after the completion of the r-tPA infusion compared to baseline as measured by core lab. 25
- All-cause mortality at hospital discharge through 30-day follow-up.
- SAEs through 30-day follow-up.
- AEs through 30-day follow-up.
- UADEs through 30-day follow-up.
- Recurrent PE through 30-day follow-up.
- Clinically Relevant Non-Major bleeding: Any sign or symptom of hemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:
- Requiring medical intervention by a healthcare professional.
- Leading to hospitalization or increased level of care.
- Prompting a face to face (i.e., not just a telephone or electronic communication) evaluation.
- Technical procedural complications.
- Systolic PA pressure measured at completion of pulse sprays and after BEC(s) removal and compared to baseline.
- Cardiac output (CO by Modified Fick calculation) and cardiac index (CI) following completion of the r-tPA pulse sprays compared to the baseline. Please refer to Terms and Definitions section for the Modified Fick calculation to be done in the IR suite / cath lab at baseline and after BEC removal).
- Conditions
- Acute Submassive Pulmonary Embolism
- Being tested
- The Bashir™ Endovascular Catheter (BEC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Bashir™ Endovascular Catheter (BECDevice
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse spray of r-tPA for the treatment of acute submassive pulmonary embolism.
| Study group | Role | What they receive |
|---|---|---|
| Patients who present with PE | Experimental | The Bashir™ Endovascular Catheter (BEC) is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. Two sizes of BECs will be used in this study Receives: Device: The Bashir™ Endovascular Catheter (BEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in RV/LV diameter ratio as measured by contrast enhanced chest CT from baseline within 48 ± 6 hours of initiation of treatment. chest CT (CTA) within 48 hours after the completion of r-tPA treatment
Reduction in RV/LV diameter ratio as measured by contrast enhanced chest CT (CTA) within 48 hours after the completion of r-tPA treatment
Measured: Through 30 day follow-up
Primary Safety Endpoint, major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of rtPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation
Major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of rtPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and:
- Fatal bleeding; and/or
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or Bleeding causing a fall in hemoglobin level of 2.0g/dL (1.24mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells
Measured: 72 hours
Secondary outcomes (10)
Refined Modified Miller Score
Refined Modified Miller Score as measured on CTA within 48 hours after the completion of the r-tPA infusion compared to baseline as measured by core lab
Measured: Within 48 hours of completion of r-TPA
All-cause mortality
All-cause mortality at hospital discharge through 30-day follow-up.
Measured: 30 DAYS
Serious adverse events
Serious adverse events through 30-day follow-up
Measured: 30 days
Adverse events
Adverse events through 30-day follow-up
Measured: 30 days
Unanticipated adverse device events
Unanticipated adverse device events through 30-day follow-up
Measured: 30 days
Recurrent pulmonary embolism through 30-day follow-up.
Recurrent pulmonary embolism through 30-day follow-up.
Measured: 30 days
Clinically relevant non-major bleeding
Any sign or symptom of hemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:
- Requiring medical intervention by a healthcare professional.
- Leading to hospitalization or increased level of care.
- Prompting a face to face (i.e., not just a telephone or electronic communication) evaluation
Measured: 30 days
Technical procedural complications.
Technical procedural complications.
Measured: 1 day
Systolic PA pressure
Systolic PA pressure measured at completion of pulse sprays and after BEC(s) removal and compared to baseline
Measured: Once r-tPA pulse sprays are given continue therapeutic anticoagulation with full does heparin or LMWH with sheaths sutured in place
Cardiac output (CO by Modified Fick calculation) and cardiac index (CI) following completion of the r-tPA pulse
Cardiac Index: Hemodynamic parameter that relates the cardiac output (CO) from right or left ventricle in one minute to body surface area (BSA), thus relating heart performance to the size of the individual. The unit of measurement is liters per minute per square meter (L/min/m2 ). CI = CO/BSA
Measured: End of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Submassive 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
- Prospective, non-randomized, multi-center study. The Bashir™ Endovascular Catheter (BEC
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parth Rali, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120179
- Sponsor's protocol ID
- The RESCUE II Study
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant tPA by Endovascular Pulse Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn
- ClinicalTrials.gov ID
- NCT06120179
- Acronym / sponsor ID
- The RESCUE II Study
- Conditions
- Acute Submassive Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 7 Nov 2023 (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 Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse spray of r-tPA for the treatment of acute submassive pulmonary embolism
Detailed description
Study Objective To demonstrate the efficacy and safety of the Bashir™ and Bashir™ S-B Endovascular Catheters for the administration of pharmaco- mechanical catheter directed therapy in a pulse spray mode using low dose r-tPA for the treatment of acute submassive pulmonary embolism. Endpoints Primary Efficacy Endpoint Reduction in RV/LV diameter ratio as measured by CTA within 48 hours after the completion of r-tPA treatment.
Primary Safety Endpoint Major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r- tPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and:
- Fatal bleeding; and/or b. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra- articular or pericardial, or intramuscular with compartment syndrome; and/or c. Bleeding causing a fall in hemoglobin level of 2.0g/dL (1.24mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells. Secondary Endpoints
- Refined Modified Miller Score as measured on CTA within 48 hours after the completion of the r-tPA infusion compared to baseline as measured by core lab. 25
- All-cause mortality at hospital discharge through 30-day follow-up.
- SAEs through 30-day follow-up.
- AEs through 30-day follow-up.
- UADEs through 30-day follow-up.
- Recurrent PE through 30-day follow-up.
- Clinically Relevant Non-Major bleeding: Any sign or symptom of hemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:
- Requiring medical intervention by a healthcare professional.
- Leading to hospitalization or increased level of care.
- Prompting a face to face (i.e., not just a telephone or electronic communication) evaluation.
- Technical procedural complications.
- Systolic PA pressure measured at completion of pulse sprays and after BEC(s) removal and compared to baseline.
- Cardiac output (CO by Modified Fick calculation) and cardiac index (CI) following completion of the r-tPA pulse sprays compared to the baseline. Please refer to Terms and Definitions section for the Modified Fick calculation to be done in the IR suite / cath lab at baseline and after BEC removal).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, multi-center study. The Bashir™ Endovascular Catheter (BEC
| Arm | Type | Receives |
|---|---|---|
| Patients who present with PE | Experimental | Device: The Bashir™ Endovascular Catheter (BECThe Bashir™ Endovascular Catheter (BEC) is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. Two sizes of BECs will be used in this study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (25 listed)
- CVA or TIA within one (1) year;
- Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
- Active bleeding from a major organ within one (1) month prior to inclusion in the study;
- Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- Patients with bleeding diatheses;
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 Catheter (BECTo demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse spray of r-tPA for the treatment of acute submassive pulmonary embolism. | Device | Patients who present with PE |
Primary outcome
Reduction in RV/LV diameter ratio as measured by contrast enhanced chest CT from baseline within 48 ± 6 hours of initiation of treatment. chest CT (CTA) within 48 hours after the completion of r-tPA treatment
Time frame: Through 30 day follow-up
Reduction in RV/LV diameter ratio as measured by contrast enhanced chest CT (CTA) within 48 hours after the completion of r-tPA treatment
Primary Safety Endpoint, major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of rtPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation
Time frame: 72 hours
Major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of rtPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and: 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 Bleeding causing a fall in hemoglobin level of 2.0g/dL (1.24mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells
10 secondary outcomes
Refined Modified Miller Score
Time frame: Within 48 hours of completion of r-TPA
All-cause mortality
Time frame: 30 DAYS
Serious adverse events
Time frame: 30 days
Adverse events
Time frame: 30 days
Unanticipated adverse device events
Time frame: 30 days
Recurrent pulmonary embolism through 30-day follow-up.
Time frame: 30 days
Clinically relevant non-major bleeding
Time frame: 30 days
Technical procedural complications.
Time frame: 1 day
Systolic PA pressure
Time frame: Once r-tPA pulse sprays are given continue therapeutic anticoagulation with full does heparin or LMWH with sheaths sutured in place
Cardiac output (CO by Modified Fick calculation) and cardiac index (CI) following completion of the r-tPA pulse
Time frame: End of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Parth Rali, MD principal investigator
Temple University
1 site 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 (BEC in people with Acute Submassive Pulmonary Embolism, run by Temple University at 1 site 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 25 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren Miller, BS (215-707-4821, lauren.e.miller@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in RV/LV diameter ratio as measured by contrast enhanced chest CT from baseline within 48 ± 6 hours of initiation of treatment. chest CT (CTA) within 48 hours after the completion of r-tPA treatment (time frame: Through 30 day follow-up). The study lists 2 primary outcomes in all. 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 7 Nov 2023.