Clot-Busting device trial halted after just one patient
NCT ID NCT05992168
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This trial tested a stent-retriever device to remove blood clots from the lungs in people with acute pulmonary embolism. Only one participant was enrolled before the study was terminated. The goal was to see if the device could reduce heart strain and avoid major complications within 48 hours.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stent-Retriever device
- What this could lead to
- If successful, this device could offer a new way to quickly remove dangerous blood clots from the lungs, potentially reducing heart strain and complications.
- What could go wrong
- The trial was terminated early with only 1 participant, so results are very limited. The device may not be safe or effective for broader use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
1 person
The number who actually took part.
- Started
-
Jan 2024
- Finished
-
Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- 1.18≤ age ≤75, no gender limitation; 2.patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance; 3.RV/LV ratio ≥0.9; 4.Patients who agreed to participate in the study and voluntarily signed the informed consent. Exclusion Criteria: 1. Patients with systolic blood pressure\<90 mmHg and lasting for 15 minutes or requiring maintenance of systolic blood pressure ≥ 90 mmHg; 2. Patients with known severe pulmonary hypertension; 3. Patients with Hematocrit \<28%; 4. Patients with known structural heart disease; 5. Patients with left bundle branch block; 6. Patients with history of chronic left heart failure and left ventricular ejection fraction ≤30%; 7. Patients with abnormal renal function (serum creatinine \> 1.8 mg/dL or \>159 umol/L); 8. Patients with known coagulopathy or bleeding tendency (platelet \<100×109/L, or INR\> 3); 9. Patients who cannot receive antiplatelet or anticoagulant therapy; 10. Patients who underwent cardiovascular or pulmonary open surgery within 7 days before peocedure; 11. Patients with intracardiac thrombosis; 12. Patients treated with extracorporeal membrane oxygenation; 13. Patients known to be allergic to contrast agents; 14. Patients with diseases that may cause difficulty in treatment or evaluation (such as malignant tumor, acute infectious disease, sepsis, general condition that cannot tolerate procedure, life expectancy less than one year, etc.); 15. Females who are pregnant or in lactation; 16. Patient is currently enrolled in another investigational study protocol; 17. Other conditions not suitable for inclusion judged by the researcher.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Peking University People'S Hospital
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.