Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism (PMT-LDCDT-PE)
A Prospective Cohort Study Comparing Percutaneous Mechanical Thrombectomy Alone Versus Percutaneous Mechanical Thrombectomy Combined With Low-Dose Catheter-Directed Thrombolysis in the Treatment of Acute Intermediate-High Risk Pulmonary Embolism
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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 upper limit of normal).
- Presence of a contraindication 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 informed consent.
Exclusion Criteria:
- Cardiac arrest at enrollment; systolic blood pressure <80 mmHg for >15 minutes unresponsive to fluid resuscitation and vasopressors.
- Active bleeding; known coagulopathy (INR >2.0 or platelet 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 (LVEF <30%); severe valvular heart disease; end-stage renal disease (eGFR <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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: PMT alone (percutaneous mechanical thrombectomy only)
PMT alone (percutaneous mechanical thrombectomy only) |
Percutaneous mechanical thrombectomy system (e.g., FlowTriever, Indigo aspiration system) |
|
Experimental: PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)
PMT 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Composite incidence of major adverse events (MAE) within 48 hours after the procedure
Zeitfenster: within 48 hours post-procedure
|
within 48 hours post-procedure
|
|
Change in the RV/LV diameter ratio from baseline to 48 hours (ΔRV/LV) measured by CTPA core laboratory
Zeitfenster: baseline and 48 hours
|
baseline and 48 hours
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- WH6-PMT-LDCDT-2026-01
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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