An interventional study of Small-bore (8-12 F) percutaneous catheter aspiration and Large-bore (16 F or larger) percutaneous catheter aspiration thrombectomy in Acute Pulmonary Embolism, sponsored by Qiu Jipeng. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Qiu Jipeng · Not applicable, Interventional, and Treatment
Acute pulmonary embolism (PE) is a serious and potentially life-threatening condition in which blood clots block the arteries of the lungs. For patients with intermediate-high-risk PE, doctors may remove the clots through a thin tube (catheter) placed into the lung arteries, a procedure called percutaneous catheter aspiration.
Two main types of catheters are used. Small-bore catheters (8-12 French) are easier to guide into the smaller, more distant branches of the lung arteries, but they remove large central clots less efficiently. Large-bore catheters (16 French or larger) remove central clots more effectively, but are harder to advance into the smaller branches. Some doctors use both types together, starting with a large-bore catheter for the central clot and then a small-bore catheter for the remaining distal clot. It is not yet known which of these three approaches is safest and works best.
This study will follow about 225 adults with intermediate-high-risk acute PE who are treated with catheter aspiration at five hospitals in China. Participants are grouped according to the catheter strategy that was actually used during their routine care: small-bore aspiration only, large-bore aspiration only, or combined large-bore plus small-bore aspiration. Information is collected from routine hospital tests, CT scans, echocardiograms, procedure records, and follow-up visits at 24 hours, 48 hours, 7 days, 30 days, and 90 days after the procedure. The study does not require any extra invasive tests or procedures.
The main goals are to compare, among the three groups: (1) the rate of major adverse events within 7 days after the procedure, and (2) the improvement in right-heart strain seen on CT scans 48 hours after the procedure. The results may help doctors choose the most suitable catheter strategy for patients with intermediate-high-risk acute PE.
Background Acute pulmonary embolism (PE) is the third leading cause of cardiovascular death worldwide. Patients with intermediate-high-risk PE are haemodynamically stable but have imaging evidence of right ventricular dysfunction and elevated cardiac biomarkers, and remain at risk of early clinical deterioration. Anticoagulation alone may be insufficient to reduce thrombus burden, whereas systemic thrombolysis carries a substantial risk of major bleeding. Percutaneous catheter-based therapy has therefore become an important treatment option. Current aspiration catheters fall into two categories: small-bore systems (8-12 F), which are highly trackable into distal pulmonary artery branches but less efficient at removing large central thrombus, and large-bore systems (16 F or larger), which remove central thrombus efficiently but may be difficult to advance into distal vessels. A combined strategy, using a large-bore catheter first for central thrombus and a small-bore catheter subsequently for residual distal thrombus, is used in clinical practice, but its safety and effectiveness have not been systematically evaluated in a prospective study.
Objective This multicentre prospective observational cohort study will compare the safety and short-term effectiveness of three catheter-based aspiration strategies in adults with intermediate-high-risk acute PE: small-bore aspiration alone, large-bore aspiration alone, and combined large-bore plus small-bore aspiration.
Study design
Consecutive patients scheduled to undergo percutaneous catheter aspiration thrombectomy as part of routine care at five participating hospitals in China are screened and enrolled after providing written informed consent. Participants are assigned to one of three cohorts according to the catheter strategy actually used during the index procedure; the strategy is selected by the treating physician according to routine clinical practice and is not allocated by the study protocol.
Data collection Baseline demographic, clinical, laboratory, CTPA, and echocardiographic data are collected before the procedure. Procedural data include angiographic findings, technique used, procedure and fluoroscopy times, and intraoperative blood loss. Clinical assessments are performed at 24 hours, 48 hours, and 7 days (or before discharge), with follow-up visits (clinic or telephone) at 30 +/- 7 days and 90 +/- 14 days. All imaging and laboratory tests are performed as part of standard care; the study requires no additional invasive procedures or examinations.
Co-primary endpoints
(1) The composite rate of major adverse events within 7 days after the procedure. (2) The change in the right ventricular to left ventricular (RV/LV) diameter ratio on CTPA from baseline to 48 hours after the procedure, measured by an independent core laboratory.
Statistical analysis Approximately 225 participants will be enrolled (about 75 per cohort). The co-primary effectiveness endpoint will be analysed by analysis of covariance adjusted for baseline RV/LV ratio; the composite safety endpoint will be analysed using logistic regression or Cox proportional hazards models. Non-inferiority of the combined strategy versus large-bore aspiration alone will be assessed for the composite major adverse event endpoint, with a pre-specified non-inferiority margin of 8%, together with a superiority assessment for the change in RV/LV ratio. Baseline imbalances will be addressed by multivariable regression and, as sensitivity analyses, by propensity score matching or inverse probability of treatment weighting. Subgroup analyses by risk category, thrombus distribution, age, sPESI, and VTE-BLEED score, and multiplicity adjustment using Bonferroni or Benjamini-Hochberg methods, are pre-specified. Missing primary endpoint data will be handled by multiple imputation. An independent data and safety monitoring board will perform an interim safety review when 50% of the planned enrolment is reached.
Expected impact The results are expected to inform clinical selection of aspiration catheter size and strategy in intermediate-high-risk acute PE, and to support standardisation of percutaneous interventional management.
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
This study's planned enrollment of 225 is above the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Qiu Jipeng is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants treated with a small-bore (8-12 F) percutaneous aspiration catheter system alone during the index procedure, as selected by the treating physician according to routine clinical practice.
Device: Small-bore (8-12 F) percutaneous catheter aspiration
Participants treated with a large-bore (16 F or larger) percutaneous aspiration/mechanical thrombectomy system alone during the index procedure, as selected by the treating physician according to routine clinical practice.
Device: Large-bore (16 F or larger) percutaneous catheter aspiration thrombectomy
Participants treated sequentially with a large-bore catheter to remove central thrombus followed by a small-bore catheter to address residual distal thrombus during the index procedure, as selected by the treating physician according to routine clinical practice.
Device: Combined large-bore and small-bore percutaneous catheter aspiration
Continuous or intermittent vacuum aspiration through a small-bore (8-12 F) catheter positioned in the pulmonary arteries to remove thrombus. Catheter selection, access site, and aspiration technique follow the treating centre's standard practice.
Mechanical aspiration-thrombectomy using a large-bore (16 F or larger) catheter system positioned in the pulmonary arteries to remove central thrombus. Device selection and technique follow the treating centre's standard practice.
Sequential use of a large-bore (16 F or larger) catheter to debulk central thrombus, followed by a small-bore (8-12 F) catheter to aspirate residual distal thrombus within the same procedure.
Composite Major Adverse Events Within 7 Days After the Procedure
Time frame: 7 days after the index procedure
Change in Right Ventricular to Left Ventricular (RV/LV) Diameter Ratio on CTPA From Baseline to 48 Hours After the Procedure
Time frame: Baseline and 48 hours after the index procedure
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Dec 2030, 50 months later.
Of 125 non-industry interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 55. This study's planned 50 months is above that.
Counting every sponsor, half of 150 studies reached it within 25 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.