Pulmonary Embolism With Acute Cor PulmonaleCATH-PENCT04473560
Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism
An observational study of Pulmonary Embolism With Acute Cor Pulmonale, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism With Acute Cor Pulmonale
- What is being tested?
- Catheter-directed thrombectomy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2018to 31 Dec 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive patients hospitalized due to high risk or intermediate-high risk pulmonary embolism.
Who may be able to join
- Clinical symptoms and presentation consistent with pulmonary embolism (PE).
- PE symptoms duration ≤ 14 days.
- High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
- Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with concomitant at least one of below criterium for minimum 24 hours:
- Systolic blood pressure > 90 mmHg and ≤ 100 mmHg
- Heart rate ≥ 110/min,
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- Arterial blood saturation <90% during spontaneous breathing (atm)
- Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with sudden occurrence of one or more of the below listed factors:
- Systolic blood pressure > 90 mmHg and ≤ 100 mmHg
- Heart rate≥ 110/min,
- Arterial blood saturation <90% during spontaneous breathing (atm)
Who cannot join
- Pregnancy.
- Refusal to sign the informed consent form.
- Presence of intracardiac thrombus.
- Diagnosed thrombophilia.
- Severe thrombocytopenia (platelets count below 20 000 µL).
- History of severe or chronic pulmonary hypertension.
- Serum creatinine level higher than 1.8 mg/dl.
- Known serious and uncontrolled sensitivity to radiographic agents.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, Greaterpoland, 61-701
Aleksander Araszkiewicz, Assoc. Prof., aaraszkiewicz@ump.edu.pl
Sylwia Sławek-Szmyt, sylwia.slawek@skpp.edu.pl
About this study
Official title: Continuous Aspiration Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism Patients
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.
The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.
Read the detailed description
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.
The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.
The primary data recorded include details of each patient's clinical status, co-morbidities with the Charlson Comorbidity Index, the implemented catheter-directed therapy, the results of additional studies (lab tests results, electrocardiogram, imaging studies), and the outcome. The study endpoints comprise technical success, clinically relevant procedure-related complications or bleeding events, classified according to the Valve Academic Research Consortium-2 guidelines criteria.
Collecting the fore mentioned data allows for clinicians to better manage the pulmonary embolism patients with increased mortality risk.
- Being tested
- Catheter-directed thrombectomy
- 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.
Catheter-directed thrombectomyDevice
Using common femoral venous access the pigtail diagnostic catheter will be placed into the main pulmonary artery and an initial pulmonary angiogram will be performed to demonstrate the location and extent of thrombi in pulmonary arteries. Then pulmonary arterial pressures will be measured. Subsequently an Indigo catheter (Penumbra, Alameda, California) will be placed and a direct-aspiration first-pass technique will be performed purposefully to attach a large thrombus to the catheter tip by suction and then pull it out through the sheath. The decision to terminate the intervention will be at operator's discretion after careful evaluation of hemodynamic parameters (restoration of the systolic blood pressure≥100 mmHg, heart rate <100/min), improvement of arterial blood saturation≥ 92%, practicable clot burden reduction and total amount of aspirated blood (no more than 300 ml).
| Study group | Role | What they receive |
|---|---|---|
| Catheter-directed thrombectomy group | Patients with acute pulmonary embolism treated with catheter-directed thrombectomy along with anticoagulation therapy Receives: Device: Catheter-directed thrombectomy | |
| No catheter-directed thrombectomy group | Patients with acute pulmonary embolism treated with anticoagulation therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pulmonary arterial pressures
Incidence of the reduction of systolic and mean pulmonary arterial pressures (mmHg) more than 10% immediately after CDT procedure.
Measured: Immediately after catheter-directed thrombectomy procedure
Reduction of vascular obstruction
Incidence of the at least 50% reduction of vascular obstruction in the angiography assessed with Miller Index score
Measured: Immediately after catheter-directed thrombectomy procedure
Clinical improvement during catheter-directed thrombectomy (CDT) procedure
Incidence of arterial blood saturation increase >92%
Measured: Immediately after catheter-directed thrombectomy procedure
Ventricular strain reduction
Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography 24 hours after the CDT.
Measured: 24 hours after catheter-directed thrombectomy
Early mortality rate from pulmonary embolism
Number of patients who died from pulmonary embolism (right heart failure) during the first 24 hours after CDT.
Measured: 24 hours after catheter-directed thrombectomy
Secondary outcomes (3)
Total mortality rate from pulmonary embolism
- Number of patients who died from pulmonary embolism (right heart failure)
Measured: 3 months after catheter-directed thrombectomy
Bleeding events incidence
Incidence of major bleedings assessed using The Valve Academic Research Consortium-2 criteria
Measured: 3 months after catheter-directed thrombectomy
Adverse events incidence
Incidence of pulmonary vascular injury assessed on angiography
Measured: 3 months after catheter-directed thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Oct 2018
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism With Acute Cor PulmonaleStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksander Araszkiewicz, Poznan University of Medical Sciences
- Investigators
- Aleksander Araszkiewicz, Assoc. Prof., Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473560
- Sponsor's protocol ID
- 879/19
- Acronym
- CATH-PE
- Status last verified
- Aug 2020
- First submitted
- 6 Jul 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported in this study, after deidentification (text, figures, tables and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Aspiration Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism Patients
- ClinicalTrials.gov ID
- NCT04473560
- Acronym / sponsor ID
- CATH-PE / 879/19
- Keywords
- pulmonary embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Jul 2020 (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.
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.
The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.
Detailed description
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.
The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.
The primary data recorded include details of each patient's clinical status, co-morbidities with the Charlson Comorbidity Index, the implemented catheter-directed therapy, the results of additional studies (lab tests results, electrocardiogram, imaging studies), and the outcome. The study endpoints comprise technical success, clinically relevant procedure-related complications or bleeding events, classified according to the Valve Academic Research Consortium-2 guidelines criteria.
Collecting the fore mentioned data allows for clinicians to better manage the pulmonary embolism patients with increased mortality risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter-directed thrombectomy group | – | Device: Catheter-directed thrombectomyPatients with acute pulmonary embolism treated with catheter-directed thrombectomy along with anticoagulation therapy |
| No catheter-directed thrombectomy group | – | –Patients with acute pulmonary embolism treated with anticoagulation therapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients hospitalized due to high risk or intermediate-high risk pulmonary embolism.
Key inclusion criteria (11 listed)
- Clinical symptoms and presentation consistent with pulmonary embolism (PE).
- PE symptoms duration ≤ 14 days.
- High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
- Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with concomitant at least one of below criterium for minimum 24 hours:
- Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with sudden occurrence of one or more of the below listed factors:
Key exclusion criteria (8 listed)
- Pregnancy.
- Refusal to sign the informed consent form.
- Presence of intracardiac thrombus.
- Diagnosed thrombophilia.
- Severe thrombocytopenia (platelets count below 20 000 µL).
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 |
|---|---|---|
| Catheter-directed thrombectomyUsing common femoral venous access the pigtail diagnostic catheter will be placed into the main pulmonary artery and an initial pulmonary angiogram will be performed to demonstrate the location and extent of thrombi in pulmonary arteries. Then pulmonary arterial pressures will be measured. Subsequently an Indigo catheter (Penumbra, Alameda, California) will be placed and a direct-aspiration first-pass technique will be performed purposefully to attach a large thrombus to the catheter tip by suction and then pull it out through the sheath. The decision to terminate the intervention will be at operator's discretion after careful evaluation of hemodynamic parameters (restoration of the systolic blood pressure≥100 mmHg, heart rate <100/min), improvement of arterial blood saturation≥ 92%, practicable clot burden reduction and total amount of aspirated blood (no more than 300 ml). | Device | Catheter-directed thrombectomy group |
Primary outcome
Reduction of pulmonary arterial pressures
Time frame: Immediately after catheter-directed thrombectomy procedure
Incidence of the reduction of systolic and mean pulmonary arterial pressures (mmHg) more than 10% immediately after CDT procedure.
Reduction of vascular obstruction
Time frame: Immediately after catheter-directed thrombectomy procedure
Incidence of the at least 50% reduction of vascular obstruction in the angiography assessed with Miller Index score
Clinical improvement during catheter-directed thrombectomy (CDT) procedure
Time frame: Immediately after catheter-directed thrombectomy procedure
Incidence of arterial blood saturation increase >92%
Ventricular strain reduction
Time frame: 24 hours after catheter-directed thrombectomy
Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography 24 hours after the CDT.
Early mortality rate from pulmonary embolism
Time frame: 24 hours after catheter-directed thrombectomy
Number of patients who died from pulmonary embolism (right heart failure) during the first 24 hours after CDT.
3 secondary outcomes
Total mortality rate from pulmonary embolism
Time frame: 3 months after catheter-directed thrombectomy
Bleeding events incidence
Time frame: 3 months after catheter-directed thrombectomy
Adverse events incidence
Time frame: 3 months after catheter-directed thrombectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in this study, after deidentification (text, figures, tables and appendices)
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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.
Aleksander Araszkiewicz, Assoc. Prof. principal investigator
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism With Acute Cor Pulmonale, run by Poznan University of Medical Sciences at 1 site in Poland.
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 11 inclusion and 8 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 18 Aug 2020. 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 Poland. 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 Aleksander Araszkiewicz, Assoc. Prof. (+488549293, aaraszkiewicz@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pulmonary arterial pressures (time frame: Immediately after catheter-directed thrombectomy procedure). The study lists 5 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 18 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.