Pulmonary EmbolismPhase 1NCT03927508
First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
A Phase 1 study testing r-tPA and The Bashir™ Endovascular Catheter in people with Pulmonary Embolism, run by Thrombolex, Inc. at 5 sites in United States.
Trial summary
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- r-tPA and The Bashir™ Endovascular Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Mar 2019to 23 Jan 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- General Inclusion Criteria:
- Willing and able to provide informed consent;
- 18 years of age and less than 75 years of age;
- PE symptom duration ≤ 14 days;
- Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT;
- RV/LV end diastolic 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
- Cerebrovascular Accident (CVA) or transient ischemic attack (TIA) within one (1) year;
- Head trauma, or other active intracranial, or intraspinal disease within one (1) year;
- Recent (within one month) or active bleeding from a major organ;
- Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- Patients with bleeding diathesis;
- Hematocrit < 30%;
Show all 29Show fewer
- Platelets < 100,000/μL;
- INR > 1.5;
- aPTT > 50 seconds in the absence of anticoagulants;
- Major surgery within fourteen (14) days;
- Serum creatinine > 2 mg/dL;
- Clinician deems high-risk for catastrophic bleeding;
- History of heparin-induced thrombocytopenia (HIT);
- Pregnancy;
- Systolic blood pressure < 90 mmHg for > 15 minutes;
- Any vasopressor support;
- Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR);
- Evidence of irreversible neurological compromise;
- Life expectancy < one (1) year;
- Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study;
- Use of non-vitamin K oral anti-coagulants (NOACs), such as Rivaroxaban, Apixaban, Dabigatran, Edoxaban within 48 hours prior to inclusion in the study;
- Use of enoxaparin sodium injection (Lovenox®) within 12 hours of procedure start time;
- Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
- Previous enrollment in this study;
- Morbidly obese (BMI >45 kg/m2) patient who by the judgement of the investigator is high risk for bleeding;
- Absolute contraindication to anticoagulation;
- Uncontrolled hypertension;
- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University Pittsburg Medical Center - Hamot
Erie, Pennsylvania, 16507
St Vincent Hospital and Health Care Center, Inc.
Indianapolis, Indiana, 46260
Columbia University Medical Center - Presbyterian - New York
New York, New York, 10032
Advent Health Orlando
Orlando, Florida, 32803
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Read the detailed description
The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution.
- Conditions
- Pulmonary Embolism
- Being tested
- r-tPA, The Bashir™ Endovascular Catheter
- Keywords
- Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-tPADrug
Pulse spray and infusion
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.
| 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: Drug: r-tPA; Device: The Bashir™ Endovascular Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Participants With Major Bleeding Events
Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients
- 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 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells.
Measured: Within 72 hours of initiation of r-tPA administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start14 Mar 2019
- Primary completion19 Dec 2019
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pulse Spray and Infusion of r-tPA
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thrombolex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927508
- Sponsor's protocol ID
- THRO-CLIN-2018-01
- Status last verified
- Mar 2023
- First submitted
- 23 Apr 2019
- Last updated
- 30 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sista AK, Bhatheja R, Rali P, Natarajan K, Green P, Piazza G, Comerota AJ, Parikh SA, Lakhter V, Bashir R, Rosenfield K. First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism. Circ Cardiovasc Interv. 2021 Jan;14(1):e009611. doi: 10.1161/CIRCINTERVENTIONS.120.009611. Epub 2020 Dec 24.
PubMed 33356383
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT03927508
- Acronym / sponsor ID
- THRO-CLIN-2018-01
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Thrombolex, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Posted 30 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Detailed description
The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pulse Spray and Infusion of r-tPA
| Arm | Type | Receives |
|---|---|---|
| BEC Treatment | Experimental | Drug: r-tPA, Device: The Bashir™ Endovascular CatheterThe Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to provide informed consent;
- 18 years of age and less than 75 years of age;
- PE symptom duration ≤ 14 days;
- Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT;
- RV/LV end diastolic diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
Key exclusion criteria (29 listed)
- Cerebrovascular Accident (CVA) or transient ischemic attack (TIA) within one (1) year;
- Head trauma, or other active intracranial, or intraspinal disease within one (1) year;
- Recent (within one month) or active bleeding from a major organ;
- Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- Patients with bleeding diathesis;
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 |
|---|---|---|
| r-tPAPulse spray and infusion | Drug | BEC Treatment |
| 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 |
Primary outcome
Safety: Number of Participants With Major Bleeding Events
Time frame: Within 72 hours of initiation of r-tPA administration.
Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients 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 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33356383Sista AK, Bhatheja R, Rali P, Natarajan K, Green P, Piazza G, Comerota AJ, Parikh SA, Lakhter V, Bashir R, Rosenfield K. First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism. Circ Cardiovasc Interv. 2021 Jan;14(1):e009611. doi: 10.1161/CIRCINTERVENTIONS.120.009611. Epub 2020 Dec 24.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing r-tPA and The Bashir™ Endovascular Catheter in people with Pulmonary Embolism, run by Thrombolex, Inc. at 5 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 7 inclusion and 29 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: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Participants With Major Bleeding Events (time frame: Within 72 hours of initiation of r-tPA administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927508, which also lists 1 linked publication.
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 30 Mar 2023.