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Not yet recruitingNCT07865572PMT-LDCDT-PEUpdated Nov 3, 2026

Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism

An interventional study of PMT alone (percutaneous mechanical thrombectomy only) and PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT) 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 2026-11-03.

Sponsored by Qiu Jipeng · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Start date movedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Acute pulmonary embolism (PE) is the third most common cardiovascular cause of death. In patients with intermediate-high risk acute PE, percutaneous mechanical thrombectomy (PMT) using large-bore catheters achieves rapid hemodynamic improvement while avoiding the bleeding risk of systemic thrombolysis, and low-dose catheter-directed thrombolysis (CDT) can dissolve residual thrombus with a lower systemic bleeding risk. This prospective, multicenter, non-randomized cohort study aims to compare the safety and efficacy of PMT alone versus PMT combined with low-dose CDT (PMT+LDCDT) in patients with acute intermediate-high risk PE. Approximately 150 patients will be enrolled and allocated to either PMT alone or PMT+LDCDT based on operator assessment. The primary safety endpoint is the composite incidence of major adverse events (MAE) within 48 hours, and the primary efficacy endpoint is the change in the right ventricular/left ventricular (RV/LV) diameter ratio from baseline to 48 hours assessed by a CTPA core laboratory.

Read the detailed description

Acute PE is the third leading cause of cardiovascular death, and patients with intermediate-high risk PE-hemodynamically stable but with imaging-confirmed right ventricular dysfunction and elevated cardiac injury biomarkers-are at substantial risk of early deterioration. PMT with large-bore catheters enables immediate thrombus removal and hemodynamic recovery without systemic thrombolytic exposure, whereas CDT delivers low-dose thrombolytics locally to dissolve residual thrombus with a reduced systemic bleeding risk. Combining PMT with low-dose CDT (PMT+LDCDT) may improve thrombus clearance without a meaningful increase in bleeding. This prospective, multicenter cohort study will enroll approximately 150 patients with acute intermediate-high risk PE at centers with pulmonary vascular interventional capability. Patients will be allocated to PMT alone or PMT+LDCDT according to the operator's pre- and intra-procedural assessment. Participants will be followed at 24 h, 48 h, 7 days/discharge, 30 days, 90 days, 6 months and 12 months. The study will evaluate safety (48-hour MAE composite: all-cause death, intracranial hemorrhage, ISTH major bleeding and other major adverse events) and efficacy (change in RV/LV diameter ratio from baseline to 48 hours by CTPA core laboratory), as well as thrombus clearance, procedure time, length of stay, and the incidence of chronic thromboembolic pulmonary hypertension (CTEPH) at 6 and 12 months.

02

Conditions studied

  • Acute Pulmonary Embolism

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03

In context

Pulmonary Embolism

832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.

This study's planned enrollment of 150 is below the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Age 18-80 years.
  • Acute pulmonary embolism confirmed by CTPA, with symptom onset to diagnosis ≤14 days.
  • Imaging evidence of right ventricular dysfunction (CTPA RV/LV diameter ratio ≥1.0, or echocardiographic right ventricular dilation/hypokinesia) and elevated cardiac injury biomarkers (troponin I or T above the ).
  • Presence of a to systemic thrombolysis, or failure of systemic thrombolysis, or clinical deterioration during anticoagulation.
  • Thrombus visible in the main pulmonary artery and/or lobar arteries on CTPA.
  • Provision of signed .

Exclusion criteria

Exclusion Criteria:

  • Cardiac arrest at enrollment; systolic blood pressure \<80 mmHg for >15 minutes unresponsive to fluid resuscitation and vasopressors.
  • Active bleeding; known coagulopathy ( >2.0 or count \<50×10⁹/L); intracranial hemorrhage within 90 days, or intracranial tumor/vascular malformation; major surgery, major trauma, or stroke within 30 days.
  • Known heparin allergy or a history of heparin-induced thrombocytopenia.
  • Prior systemic thrombolytic therapy.
  • Known chronic thromboembolic pulmonary hypertension (CTEPH); severe left ventricular dysfunction ( \<30%); severe valvular heart disease; end-stage renal disease ( \<30 mL/min/1.73 m²); pregnancy or lactation.
  • Intracardiac or intrapulmonary mass on CTPA; severe stenosis or occlusion of the inferior vena cava or iliofemoral vein.
  • CTPA image quality inadequate for independent core laboratory interpretation.
  • Current participation in another clinical study that could interfere with endpoint assessment.
Terms in these criteria, in plain language(7)

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.

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.

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    PMT alone (percutaneous mechanical thrombectomy only)

    PMT alone (percutaneous mechanical thrombectomy only)

    Device: PMT alone (percutaneous mechanical thrombectomy only)

  • Experimental
    PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)

    PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)

    Device: PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)

Interventions

  • DevicePMT alone (percutaneous mechanical thrombectomy only)

    Percutaneous mechanical thrombectomy system (e.g., FlowTriever, Indigo aspiration system)

  • DevicePMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)

    Low-dose catheter-directed thrombolysis: Alteplase (rt-PA), ≤20 mg (≤10 mg per lung), infused over ≤30 min via pulmonary artery catheter

06

What researchers measure

Primary outcomes

  1. Composite incidence of major adverse events (MAE) within 48 hours after the procedure

    Time frame: within 48 hours post-procedure

  2. Change in the RV/LV diameter ratio from baseline to 48 hours (ΔRV/LV) measured by CTPA core laboratory

    Time frame: baseline and 48 hours

07

Study locations

No study locations are listed for this record.

08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2030, 49 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 49 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.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 3, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2026
First posted
Oct 8, 2026
StartEst.
Nov 10, 2026was Oct 2026
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2031
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 1, 2026→Nov 10, 2026
Nov 3, 2026
Registered
First appeared on the registry
Oct 8, 2026
Show all 2 updates
  1. Nov 3, 2026
    Start date Oct 1, 2026→Nov 10, 2026
    + 1 other change: verification date
  2. Oct 8, 2026
    First appeared on the registry

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 ↗

09

Registry details

Key details

Study ID
NCT07865572
Lead sponsor
Qiu Jipeng
Responsible party
Qiu Jipeng (Physician, Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University) — Sponsor-investigator
First posted
Oct 8, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Nov 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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