Comparing two ways to remove blood clots from the lungs: how different catheter sizes affect heart recovery and patient outcomes in serious pulmonary embolism
| ISRCTN | ISRCTN12573451 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12573451 |
- Submission date
- 23/08/2025
- Registration date
- 05/09/2025
- Last edited
- 05/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Pulmonary embolism (PE) is a serious condition caused by blood clots blocking arteries in the lungs. These clots often come from the legs and can lead to death or long-term problems like difficulty breathing during everyday activities. This study looks at two different types of catheters (thin tubes used in treatment) to remove clots from the lungs. One is a standard-size catheter, and the other is a larger one that might work better for bigger or older clots. The aim is to find out which catheter is more effective and safer for patients with a type of PE called “submassive PE.”
Who can participate?
Adults aged 18 to 74 who have submassive PE and meet certain medical criteria may be eligible. Participation depends on the availability of the large-bore catheter system at the hospital.
What does the study involve?
Participants receive treatment using either a standard-size catheter or a large-bore catheter to remove blood clots from their lungs. The type of catheter used is based on what is available at the time—not on the doctor’s or patient’s choice. The study monitors recovery and any complications after the procedure.
What are the possible benefits and risks of participating?
The potential benefit is improved treatment for PE, which may help with breathing and reduce long-term health problems. So far, no complications have occurred in the pilot phase. However, as with any medical procedure, there are risks such as bleeding, injury to blood vessels, or other unexpected issues.
Where is the study run from?
John Paul II Hospital in Krakow, Poland.
When is the study starting and how long is it expected to run for?
March 2023 to December 2026.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Piotr Musiałek, pmusialek@szpitaljp2.krakow.pl
Dr. Łukasz Tekieli, ltekieli@szpitaljp2.krakow.pl
Contact information
Public, Principal Investigator
Pradnicka 80 str.
Krakow
31-202
Poland
 ORCID ID |
0000-0001-9300-4833 |
|---|---|
| Phone | +48 6142111 |
| pmusialek@szpitaljp2.krakow.pl |
Scientific
Pradnicka 80 str.
Krakow
31-202
Poland
| ORCID ID |
0000-0002-3431-1013 |
|---|---|
| Phone | +48 6142287 |
| ltekieli@szpitaljp2.krakow.pl |
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Pulmonary thromboembolism mechanical OFFLOAD, right ventricle recovery and clinical outcomes using percutaneous large-bore vs conventional-bore embolectomy in intermediate-high risk Pulmonary Embolism: PE-OFFLOAD (Krakow) Study |
| Study acronym | PE-OFFLOAD (Krakow) Study |
| Study objectives | There has been a trend to increase the diameter of pulmonary thrombus evacuation catheters; however, no studies to date have directly compared conventional vs. large-bore devices for embolectomy in pulmonary embolism (PE). This study is performed to evaluate, in patients with intermediate-high risk (submassive) PE undergoing mechanical evacuation of the clots from the lungs, the safety and efficacy of standard-bore vs. large-bore device pulmonary embolectomy catheters. Principal outcomes are clinical recovery and right ventricle recovery. |
| Ethics approval(s) |
Approved 04/11/2022, The Bioethical Committee at the Krakow District Medical Chamber (Kurpnicza 11A str., Krakow, 31-123, Poland; +48 126191712; a.krawczyk@hipokrates.org), ref: OIL/KBL/61/2022 |
| Health condition(s) or problem(s) studied | Acute submassive (intermediate-high risk) pulmonary embolism |
| Intervention | In local anesthesia, after femoral vein puncture and 8F sheath insertion, the 6F pigtail catheter (0.035’ standard wire-supported) is introduced into the pulmonary trunk using a typical technique. The maximal, minimal, and average pulmonary pressures are recorded. Baseline arteriography is performed to localize the thrombus and assess perfusion. With the 0.035’ stiff wire support, the diagnostic catheter is replaced by an 8F or 20F thrombectomy catheter (random treatment allocation occurs via sealed envelopes). Selective cannulation of the affected branches is followed by aspiration of the thrombotic material. Multiple passes are performed as required, depending on the clot burden and location(s). Post-procedural angiography is performed to assess flow restoration and residual thrombus burden. Repeat measurements of pulmonary pressures are taken. If the residual clot burden remains large and there is no significant drop in pulmonary pressure, typical perfusion catheters are introduced to both pulmonary arteries, and infusion of 10mg of rt-PA (each lung) is performed for 2 hours. Finally, the perfusion catheters and the femoral sheath are removed as per standard procedure. Typical non-invasive imaging is performed as per the center routine, involving transthoracic echocardiography and CT angiography at baseline and at 48-hours post-procedure. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 8F Indigo CAT 8 system (Penumbra, Inc.), 20F Magneto Thrombectomy Solutions’ eTrieve Catheter (Magneto Thrombectomy Solutions, Israel) |
| Primary outcome measure | Combined (hierarchical) clinical endpoint of death by 30-days or NYHA>2 at 7-days post-procedure or oxygen therapy need at 72-hours |
| Secondary outcome measures | Measured using patient records: 1. Failure to reach at least 30% reduction in RV/LV ratio by CTA at 48 hours 2. Death by 30 days 3. NYHA class greater than 2 at 7 days post-procedure 4. Oxygen therapy needed at 72 hours 5. In-hospital death 6. Major bleeding during procedure 7. Pulmonary artery injury during procedure 8. Cardiac tamponade during procedure 9. Clinical deterioration during the procedure 10. Cardiac arrest during the procedure 11. Duration of hospitalization 12. RV/LV ratio at 48 hours 13. Percentage RV/LV ratio reduction 14. Pulmonary artery systolic pressure reduction at end of procedure 15. Pulmonary artery mean pressure reduction at end of procedure 16. NT-proBNP level at 48 hours (pg/ml) 17. Hemoglobin level at 48 hours (g/dl) 18. Need for red blood cell transfusion 19. Total number of days of hospitalization 20. CTA evidence of pulmonary offload (Miller score) at 48h vs baseline |
| Overall study start date | 30/03/2023 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 74 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE) 2. PE symptom duration of 14 days or less 3. CT angiography (CTA) evidence of PE 4. RV/LV ratio of 0.9 or greater measured via CT, as determined by the investigational site 5. Heart rate less than 130 beats per minute prior to procedure 6. Subject deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment 7. Age between 18 and 74 years |
| Key exclusion criteria | 1. Thrombolytic use within 14 days of baseline CTA 2. Known bleeding diathesis or coagulation disorder 3. Any contraindication to systemic therapeutic doses of heparin or other anticoagulants 4. Hemodynamic collapse at presentation defined as any of the below: 4.1. Need for cardiopulmonary resuscitation 4.2. Systolic blood pressure < 90 mm Hg for at least 15 min 4.3. Drop of systolic blood pressure by at least 40 mm Hg for at least 15 min with signs of end organ hypoperfusion (cold extremities or urinary output < 30 mL/h or mental status changes) 4.4. Need for catecholamine administration to maintain adequate organ perfusion and a systolic blood pressure of > 90 mm Hg 5. Decompensated heart failure 6. Presence of Extra-Corporeal Membrane Oxygenation 7. Major trauma ISS > 15 within 14 days 8. Cardiovascular or pulmonary surgery within last 7 days 9. FiO₂ requirement > 40% or > 6 LPM to keep oxygen saturation > 90% 10. Laboratory findings: 10.1. Hematocrit < 28% 10.2. Platelets < 100,000/µL 10.3. Serum creatinine > 1.8 mg/dL 10.4. INR > 2 11. Left bundle branch block 12. Pulmonary hypertension with peak PAP > 70 mmHg measured either by echocardiography or right heart catheterization 13. Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention 14. Presence of intracardiac lead in right ventricle or atrium 15. Pacemaker or Implantable Cardioverter Defibrillator 16. Presence of intracardiac thrombus 17. Known anaphylactic reaction to radiographic contrast agents that cannot be pre-treated 18. Known right-to-left shunt, for example from large patent foramen ovale or arterial septal defect 19. Known left ventricular ejection fraction ≤ 30% 20. History of severe chronic pulmonary arterial hypertension 21. History of underlying lung disease with oxygen dependence 22. History of chest irradiation 23. History of Heparin Induced Thrombocytopenia (HIT) 24. Female who is pregnant or nursing 25. Current participation in another investigational drug or device treatment study 26. Life expectancy of < 90 days as determined by the investigator 27. Subjects who are intubated |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Poland
Study participating centre
Krakow
31-202
Poland
Sponsor information
University/education
Pradnicka 80 str.
Krakow
31-202
Poland
| Phone | +48 6142287 |
|---|---|
| t.durek@szpitaljp2.krakow.pl | |
| Website | https://www.uj.edu.pl/pl |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Editorial Notes
05/09/2025: Trial's existence confirmed by The Bioethical Committee at the Krakow District Medical Chamber.
