Pulmonary Embolism Subacute MassiveEarly Phase 1NCT05612854
Catheter Directed Therapy in Intermediate Risk Pulmonary Embolism Patients
A Early Phase 1 study testing Mechanical embolectomy: by hydromechanical defragmentation by pigtail and Suction embolectomy by the Penumbra Indigo aspiration system in people with Pulmonary Embolism Subacute Massive, run by Assiut University.
Trial summary
Aim of the work: 1. To compare conventional medical therapy versus catheter-directed therapy in intermediate high risk acute pulmonary embolism. 2. To define predictors of progression from intermediate to high-risk in medically-treated patients for ideal timing for intervention. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pulmonary Embolism Subacute Massive
- What is being tested?
- Mechanical embolectomy: by hydromechanical defragmentation by pigtail and Suction embolectomy by the Penumbra Indigo aspiration system
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2022to 30 Dec 2024
- Phase
- Early Phase 1
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute pulmonary embolism patients (confirmed by CT pulmonary angiography [CTPA])
- symptoms started within 15 days of enrollment
- intermediate-high risk pulmonary embolism patients , i.e., who have all of the following risk indicators combined :(2) i.Pulmonary Embolism Severity Index (PESI) class III-V or sPESI ≥1, ii.AND RV dysfunction on TTE or CTPA, iii.AND elevated cardiac troponin levels
- with none of the following high-risk presentations: cardiac arrest, systolic blood pressure <90 mmHg, or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status, or end-organ hypoperfusion.
Who cannot join
- high risk patients who are hemodynamically unstable (cardiogenic shock, SBP <90 mmHg, or use of intotropic support).
- low risk patients with no RV dysfunction.
- Patients with history of CTEPH (or previous acute PE)
- Patients known to have other pulmonary hypertension, apart from group IV (CTEPH).
- Patients with sever kidney injury (eGFR <30 mg/dl/1.7m2).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Catheter Directed Therapy for Intermediate Risk Pulmonary Embolism Patients Guided by Prediction Model for Impending Shock
Aim of the work:
- To compare conventional medical therapy versus catheter-directed therapy in intermediate high risk acute pulmonary embolism.
- To define predictors of progression from intermediate to high-risk in medically-treated patients for ideal timing for intervention.
Read the detailed description
Based on history, physical examination, surface 12-lead ECG, bed-side echocardiography, patients with a high probability of acute pulmonary embolism are selected and subjected to CT pulmonary angiography to confirm the diagnosis and calculate the pulmonary artery obstruction score.
Routine labs are withdrawn, including cardiac troponin.Methods:
Detailed TTE will be done with emphasis on the following indicators of RV strain and/or dysfunction:
- Echocardiography findings that are indicative of RV dysfunction
- tricuspid annular plane systolic excursion (TAPSE)
- S' Velocity
- the McConnell's sign
- RV dilation
- interventricular septal flattening.
- elevated right ventricular pressures
- plethoric inferior vena cava
- tricuspid regurgitation
- Direct visualization of thromboembolic in the RT heart and PA
- RV stroke volume measured by RVOT VTI.
- LV stroke volume measured by LVOT VTI Intermediate-high risk patient will be identified (based on the calculated pulmonary embolism severity index, RV dysfunction on TTE and/or CT, cardiac troponin), and then randomized to either receiving conventional medical treatment or catheter-directed interventional therapy if the patient consents.
- Catheter directed therapy
- Mechanical embolectomy:
Mechanical fragmentation will be done using a 6 F pigtail catheter inserted inside the thrombus guided by the CTPA images.
Hydro-mechanical defragmentation (HMD) is one of the CDT modalities for high-risk PE patients, in which rapid pigtail rotation is combined with heparinized saline injection for thrombus fragmentation.(4)
- Suction embolectomy:
Suction embolectomy was one of the earliest techniques for transcatheter treatment of PE, and was introduced by Greenfield et al, using a 12-Fr catheter with a cup on its distal end. Suction was applied manually to the catheter hub with a large syringe. (13) The Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) that will be used, is an 8-Fr device and its associated tubing, pump, and separator, has the flexibility for placement in segmental branches of the pulmonary arteries. The Indigo aspiration system is indicated for use in the peripheral arterial system and the pulmonary arteries, receiving U.S. Food and Drug Administration 510(k) clearance for PE in December 2019.(14)
- Catheter directed thrombolysis:
Catheter-directed thrombolysis allows delivery of the thrombolytic agent directly to the area of highest embolic burden via a catheter.
Intermediate-high risk patient will be identified (based on the calculated pulmonary embolism severity index, RV dysfunction on TTE and/or CT, cardiac troponin), and then randomized to either receiving conventional medical treatment or catheter-directed interventional therapy if the patient consents.
- Conditions
- Pulmonary Embolism Subacute Massive
- Being tested
- Mechanical embolectomy: by hydromechanical defragmentation by pigtail, Suction embolectomy by the Penumbra Indigo aspiration system
- Keywords
- catheter directed therapy, intermediate risk pulmonary embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical embolectomy: by hydromechanical defragmentation by pigtailProcedure or surgery
Hydro-mechanical defragmentation (HMD) is one of the CDT modalities for high-risk PE patients, in which rapid pigtail rotation is combined with heparinized saline injection for thrombus fragmentation
Suction embolectomy by the Penumbra Indigo aspiration systemDevice
The Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) that will be used, is an 8-Fr device and its associated tubing, pump, and separator, has the flexibility for placement in segmental branches of the pulmonary arteries.
510(k) Number :K160449 FOIA Releasable 510(k) K160449 Device Name:Penumbra System, Penumbra Pump MAX
| Study group | Role | What they receive |
|---|---|---|
| catheter directed therapy group in intermediate risk pulmonary embolism patients | Active comparator | in this arm, intermediated risk pulmonary embolism patients is treated by intervention in the form of:
* A. Mechanical embolectomy: by hydromechanical defragmentation by pigta
* B. Suction embolectomy: using The Penumbra Indigo aspiration system
* C. Catheter directed thrombolysis: Receives: Procedure: Mechanical embolectomy: by hydromechanical defragmentation by pigtail; Device: Suction embolectomy by the Penumbra Indigo aspiration system |
| medical therapy group in intermediate risk pulmonary embolism patients | Active comparator | in this arm, intermediated risk pulmonary embolism patients is treated by routine anticoagulation only. Receives: Procedure: Mechanical embolectomy: by hydromechanical defragmentation by pigtail; Device: Suction embolectomy by the Penumbra Indigo aspiration system |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients
comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by clinical assessment of occurrence of major adverse cardiac events.
Measured: up to 2 years
1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients
comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by echocardiographic assessment of right ventricular function by TAPSE (mm) , RV/LV diameter ratio ,TR peak gradient (mmHg)
Measured: up to 2 years
1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients
comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by CT pulmonary angiography to asses embolus size and Pulmonary artery obstruction index
Measured: up to 2 years
Secondary outcomes (1)
predictors of progression from intermediate to high-risk acute pulmonary embolism patients
identifying predictors for ideal timing for intervention in intermediate risk pulmonary embolism patients who are medically-treated by new echocardiographic parameters (LVOT velocity time integral and RVOT velocity time integral)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start30 Dec 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism Subacute MassiveStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, open-label, parallel-assignment, prospective study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman khairy Mohamed, Assiut University
- Investigators
- Shrouk K Ali, MSc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612854
- Sponsor's protocol ID
- CDT in pulmonary embolism
- Status last verified
- Nov 2022
- First submitted
- 16 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.
PubMed 25173341Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C, Barnes GD. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association. Circulation. 2019 Nov 12;140(20):e774-e801. doi: 10.1161/CIR.0000000000000707. Epub 2019 Oct 4.
PubMed 31585051Hassan AKM, Ahmed H, Ahmed Y, Elfadl AA, Omar A. Efficacy and safety of hydro-mechanical defragmentation in intermediate- and high-risk pulmonary embolism. Egypt Heart J. 2021 Sep 25;73(1):84. doi: 10.1186/s43044-021-00204-2.
PubMed 34564780Kroupa J, Buk M, Weichet J, Malikova H, Bartova L, Linkova H, Ionita O, Kozel M, Motovska Z, Kocka V. A pilot randomised trial of catheter-directed thrombolysis or standard anticoagulation for patients with intermediate-high risk acute pulmonary embolism. EuroIntervention. 2022 Oct 7;18(8):e639-e646. doi: 10.4244/EIJ-D-21-01080.
PubMed 35620984
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Directed Therapy for Intermediate Risk Pulmonary Embolism Patients Guided by Prediction Model for Impending Shock
- ClinicalTrials.gov ID
- NCT05612854
- Acronym / sponsor ID
- CDT in pulmonary embolism
- Conditions
- Pulmonary Embolism Subacute Massive
- Keywords
- catheter directed therapy, intermediate risk pulmonary embolism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 Nov 2022 (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.
Aim of the work:
- To compare conventional medical therapy versus catheter-directed therapy in intermediate high risk acute pulmonary embolism.
- To define predictors of progression from intermediate to high-risk in medically-treated patients for ideal timing for intervention.
Detailed description
Based on history, physical examination, surface 12-lead ECG, bed-side echocardiography, patients with a high probability of acute pulmonary embolism are selected and subjected to CT pulmonary angiography to confirm the diagnosis and calculate the pulmonary artery obstruction score.
Routine labs are withdrawn, including cardiac troponin.Methods:
Detailed TTE will be done with emphasis on the following indicators of RV strain and/or dysfunction:
- Echocardiography findings that are indicative of RV dysfunction
- tricuspid annular plane systolic excursion (TAPSE)
- S' Velocity
- the McConnell's sign
- RV dilation
- interventricular septal flattening.
- elevated right ventricular pressures
- plethoric inferior vena cava
- tricuspid regurgitation
- Direct visualization of thromboembolic in the RT heart and PA
- RV stroke volume measured by RVOT VTI.
- LV stroke volume measured by LVOT VTI Intermediate-high risk patient will be identified (based on the calculated pulmonary embolism severity index, RV dysfunction on TTE and/or CT, cardiac troponin), and then randomized to either receiving conventional medical treatment or catheter-directed interventional therapy if the patient consents.
- Catheter directed therapy
- Mechanical embolectomy:
Mechanical fragmentation will be done using a 6 F pigtail catheter inserted inside the thrombus guided by the CTPA images.
Hydro-mechanical defragmentation (HMD) is one of the CDT modalities for high-risk PE patients, in which rapid pigtail rotation is combined with heparinized saline injection for thrombus fragmentation.(4)
- Suction embolectomy:
Suction embolectomy was one of the earliest techniques for transcatheter treatment of PE, and was introduced by Greenfield et al, using a 12-Fr catheter with a cup on its distal end. Suction was applied manually to the catheter hub with a large syringe. (13) The Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) that will be used, is an 8-Fr device and its associated tubing, pump, and separator, has the flexibility for placement in segmental branches of the pulmonary arteries. The Indigo aspiration system is indicated for use in the peripheral arterial system and the pulmonary arteries, receiving U.S. Food and Drug Administration 510(k) clearance for PE in December 2019.(14)
- Catheter directed thrombolysis:
Catheter-directed thrombolysis allows delivery of the thrombolytic agent directly to the area of highest embolic burden via a catheter.
Intermediate-high risk patient will be identified (based on the calculated pulmonary embolism severity index, RV dysfunction on TTE and/or CT, cardiac troponin), and then randomized to either receiving conventional medical treatment or catheter-directed interventional therapy if the patient consents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled, open-label, parallel-assignment, prospective study
| Arm | Type | Receives |
|---|---|---|
| catheter directed therapy group in intermediate risk pulmonary embolism patients | Active comparator | Procedure: Mechanical embolectomy: by hydromechanical defragmentation by pigtail, Device: Suction embolectomy by the Penumbra Indigo aspiration systemin this arm, intermediated risk pulmonary embolism patients is treated by intervention in the form of: * A. Mechanical embolectomy: by hydromechanical defragmentation by pigta * B. Suction embolectomy: using The Penumbra Indigo aspiration system * C. Catheter directed thrombolysis: |
| medical therapy group in intermediate risk pulmonary embolism patients | Active comparator | Procedure: Mechanical embolectomy: by hydromechanical defragmentation by pigtail, Device: Suction embolectomy by the Penumbra Indigo aspiration systemin this arm, intermediated risk pulmonary embolism patients is treated by routine anticoagulation only. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute pulmonary embolism patients (confirmed by CT pulmonary angiography [CTPA])
- symptoms started within 15 days of enrollment
- intermediate-high risk pulmonary embolism patients , i.e., who have all of the following risk indicators combined :(2) i.Pulmonary Embolism Severity Index (PESI) class III-V or sPESI ≥1, ii.AND RV dysfunction on TTE or CTPA, iii.AND elevated cardiac troponin levels
- with none of the following high-risk presentations: cardiac arrest, systolic blood pressure <90 mmHg, or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status, or end-organ hypoperfusion.
Key exclusion criteria (5 listed)
- high risk patients who are hemodynamically unstable (cardiogenic shock, SBP <90 mmHg, or use of intotropic support).
- low risk patients with no RV dysfunction.
- Patients with history of CTEPH (or previous acute PE)
- Patients known to have other pulmonary hypertension, apart from group IV (CTEPH).
- Patients with sever kidney injury (eGFR <30 mg/dl/1.7m2).
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 |
|---|---|---|
| Mechanical embolectomy: by hydromechanical defragmentation by pigtailHydro-mechanical defragmentation (HMD) is one of the CDT modalities for high-risk PE patients, in which rapid pigtail rotation is combined with heparinized saline injection for thrombus fragmentation | Procedure or surgery | catheter directed therapy group in intermediate risk pulmonary embolism patients, medical therapy group in intermediate risk pulmonary embolism patients |
| Suction embolectomy by the Penumbra Indigo aspiration systemThe Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) that will be used, is an 8-Fr device and its associated tubing, pump, and separator, has the flexibility for placement in segmental branches of the pulmonary arteries. 510(k) Number :K160449 FOIA Releasable 510(k) K160449 Device Name:Penumbra System, Penumbra Pump MAX | Device | catheter directed therapy group in intermediate risk pulmonary embolism patients, medical therapy group in intermediate risk pulmonary embolism patients |
Primary outcome
1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients
Time frame: up to 2 years
comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by clinical assessment of occurrence of major adverse cardiac events.
1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients
Time frame: up to 2 years
comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by echocardiographic assessment of right ventricular function by TAPSE (mm) , RV/LV diameter ratio ,TR peak gradient (mmHg)
1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients
Time frame: up to 2 years
comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by CT pulmonary angiography to asses embolus size and Pulmonary artery obstruction index
1 secondary outcome
predictors of progression from intermediate to high-risk acute pulmonary embolism patients
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 25173341Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.
- Background: PubMed 31585051Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C, Barnes GD. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association. Circulation. 2019 Nov 12;140(20):e774-e801. doi: 10.1161/CIR.0000000000000707. Epub 2019 Oct 4.
- Background: PubMed 34564780Hassan AKM, Ahmed H, Ahmed Y, Elfadl AA, Omar A. Efficacy and safety of hydro-mechanical defragmentation in intermediate- and high-risk pulmonary embolism. Egypt Heart J. 2021 Sep 25;73(1):84. doi: 10.1186/s43044-021-00204-2.
- Background: PubMed 35620984Kroupa J, Buk M, Weichet J, Malikova H, Bartova L, Linkova H, Ionita O, Kozel M, Motovska Z, Kocka V. A pilot randomised trial of catheter-directed thrombolysis or standard anticoagulation for patients with intermediate-high risk acute pulmonary embolism. EuroIntervention. 2022 Oct 7;18(8):e639-e646. doi: 10.4244/EIJ-D-21-01080.
- 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.
Shrouk K Ali, MSc principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mechanical embolectomy: by hydromechanical defragmentation by pigtail and Suction embolectomy by the Penumbra Indigo aspiration system in people with Pulmonary Embolism Subacute Massive, run by Assiut University.
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 4 inclusion and 5 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 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shrouk K Ali, MSc (+0201225134030, shrouk31@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients (time frame: up to 2 years). The study lists 3 primary outcomes in all. 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 NCT05612854, which also lists 4 linked publications.
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 10 Nov 2022.