Pulmonary EmbolismRiTEPNCT06348459
Registry of Catheter Intervention in Pulmonary Embolism
An observational study of Pulmonary Embolism and Pulmonary Embolism Acute Massive, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Pulmonary Embolism Acute Massive, Pulmonary Embolism Acute
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2018to 31 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients admitted for moderate-high risk or high-risk PE and treated invasively with any kind of catheter-directed intervention.
Who may be able to join
- adult patients (aged 18 years old or older)
- confirmed diagnosis of acute PE (on computed tomography or echocardiogram plus pulmonary angiography)
- high-risk PE or intermediate-high risk according to ESC risk stratification in the 2019 guidelines (briefly, elevated cardiac biomarkers [troponin or N-terminal pro-B-type natriuretic peptide], and right ventricle to left ventricle ratio > 0.9 [on computed tomography or echocardiogram], and PE severity index III to IV or simplified PE severity index=1
- eligibility for catheter-directed intervention
Who cannot join
- unconfirmed diagnosis of PE
- undefined risk stratification, and
- PE with uncertain chronology or beyond seven days of symptom initiation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid, Madrid, 28040
Pablo Salinas, MD, PhD, +34913303000, salinas.pablo@gmail.com
About this study
Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism.
- Conditions
- Pulmonary Embolism, Pulmonary Embolism Acute Massive, Pulmonary Embolism Acute, Pulmonary Embolism and Thrombosis, Pulmonary Thromboembolisms
- Keywords
- Aspiration Thrombectomy, Percutaneous Aspiration Thrombectomy, Local Thrombolysis
- Medical subject headings
- Pulmonary Embolism, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause-death
Measured: during hospital admission (up to day 10)
Secondary outcomes (5)
all cause-death
Measured: 48 hours
all cause-death
Measured: 30 days
all cause-death
Measured: 2 year
procedural success
defined as technical procedure completed without procedural complications or 48-hour death
Measured: 48 hours
in-hospital complications
Measured: during hospital admission (up to day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start18 Sep 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología
- Responsible party
- Principal investigator, Pablo Salinas, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348459
- Sponsor's protocol ID
- 18/010-E
- Acronym
- RiTEP
- Status last verified
- Oct 2026
- First submitted
- 9 Nov 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramos-Lopez N, Ferrera C, Luque T, Enriquez-Vazquez D, Mahia-Casado P, Galvan-Herraez L, Pedrajas JM, Salinas P; working group. Impact of a pulmonary embolism response team initiative on hospital mortality of patients with bilateral pulmonary embolism. Med Clin (Barc). 2023 Jun 9;160(11):469-475. doi: 10.1016/j.medcli.2022.12.017. Epub 2023 Feb 16. English, Spanish.
PubMed 36801109Salinas P, Vazquez-Alvarez ME, Salvatella N, Ruiz Quevedo V, Velazquez Martin M, Valero E, Rumiz E, Jurado-Roman A, Lozano I, Gallardo F, Amat-Santos IJ, Lorenzo O, Portero Portaz JJ, Huanca M, Nombela-Franco L, Vaquerizo B, Ramallal Martinez R, Maneiro Melon NM, Sanchis J, Berenguer A, Gallardo-Lopez A, Gutierrez-Ibanes E, Mejia-Renteria H, Cordoba-Soriano JG, Jimenez-Mazuecos JM. Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):138-147. doi: 10.1016/j.rec.2023.06.005. Epub 2023 Jun 22. English, Spanish.
PubMed 37354942
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Catheter Intervention in Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06348459
- Acronym / sponsor ID
- RiTEP / 18/010-E
- Conditions
- Pulmonary Embolism, Pulmonary Embolism Acute Massive, Pulmonary Embolism Acute, Pulmonary Embolism and Thrombosis, Pulmonary Thromboembolisms
- Keywords
- Aspiration Thrombectomy, Percutaneous Aspiration Thrombectomy, Local Thrombolysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Apr 2024 (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.
Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted for moderate-high risk or high-risk PE and treated invasively with any kind of catheter-directed intervention.
Key inclusion criteria (4 listed)
- adult patients (aged 18 years old or older)
- confirmed diagnosis of acute PE (on computed tomography or echocardiogram plus pulmonary angiography)
- high-risk PE or intermediate-high risk according to ESC risk stratification in the 2019 guidelines (briefly, elevated cardiac biomarkers [troponin or N-terminal pro-B-type natriuretic peptide], and right ventricle to left ventricle ratio > 0.9 [on computed tomography or echocardiogram], and PE severity index III to IV or simplified PE severity index=1
- eligibility for catheter-directed intervention
Key exclusion criteria (3 listed)
- unconfirmed diagnosis of PE
- undefined risk stratification, and
- PE with uncertain chronology or beyond seven days of symptom initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause-death
Time frame: during hospital admission (up to day 10)
5 secondary outcomes
all cause-death
Time frame: 48 hours
all cause-death
Time frame: 30 days
all cause-death
Time frame: 2 year
procedural success
Time frame: 48 hours
in-hospital complications
Time frame: during hospital admission (up to day 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 36801109Ramos-Lopez N, Ferrera C, Luque T, Enriquez-Vazquez D, Mahia-Casado P, Galvan-Herraez L, Pedrajas JM, Salinas P; working group. Impact of a pulmonary embolism response team initiative on hospital mortality of patients with bilateral pulmonary embolism. Med Clin (Barc). 2023 Jun 9;160(11):469-475. doi: 10.1016/j.medcli.2022.12.017. Epub 2023 Feb 16. English, Spanish.
- Results publication: PubMed 37354942Salinas P, Vazquez-Alvarez ME, Salvatella N, Ruiz Quevedo V, Velazquez Martin M, Valero E, Rumiz E, Jurado-Roman A, Lozano I, Gallardo F, Amat-Santos IJ, Lorenzo O, Portero Portaz JJ, Huanca M, Nombela-Franco L, Vaquerizo B, Ramallal Martinez R, Maneiro Melon NM, Sanchis J, Berenguer A, Gallardo-Lopez A, Gutierrez-Ibanes E, Mejia-Renteria H, Cordoba-Soriano JG, Jimenez-Mazuecos JM. Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):138-147. doi: 10.1016/j.rec.2023.06.005. Epub 2023 Jun 22. English, Spanish.
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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.
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 and Pulmonary Embolism Acute Massive, run by Hospital San Carlos, Madrid at 1 site in Spain.
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 3 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pablo Salinas, MD, PhD (+34 913303000, salinas.pablo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause-death (time frame: during hospital admission (up to day 10)). 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 NCT06348459, which also lists 2 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 6 Oct 2026.