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PERCUTANEOUS EMBOLECTOMY, ULTRASOUND ASSISTED LOW DOSE THROMBOLYSIS OR HEPARIN FOR INTERMEDIATE HIGH RISK PULMONARY EMBOLISM (STRATIFY II)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515712-45-00
Enrollment
210
Registered
2024-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary embolism

Brief summary

Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous treated groups (embolectomy and USAT combined) to heparin/LMWH group (n=140 versus n=70), Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous embolectomy and USAT (n=70 versus n=70)

Detailed description

Bleeding complications (major and minor bleeding complication according the TIMI classification), Duration of index admission, including hospital-based rehabilitation, Dyspnoea index (Visual analogue scale) after 48-96 h and after 3 months, Rate of further interventions for pulmonary embolism during admission (embolectomy, full dose thrombolysis, mechanical ventilation, need for vasopressors, cardiopulmonary resuscitation, VA-ECMO etc.), Mortality in the three arms (log-rank), and hazard ratio in multivariable analysis using the UFH/LMWH as reference., Incidence of tricuspid regurgitation (TR) gradient > 40 mmHg at 3 months follow-up echocardiography, Six-minute walking distance (6MWD) at 3 months follow-up comparing the three groups, Quality of life (PEmbQoL) at 3 months follow-up comparing the three groups

Interventions

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous treated groups (embolectomy and USAT combined) to heparin/LMWH group (n=140 versus n=70), Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous embolectomy and USAT (n=70 versus n=70)

Secondary

MeasureTime frame
Bleeding complications (major and minor bleeding complication according the TIMI classification), Duration of index admission, including hospital-based rehabilitation, Dyspnoea index (Visual analogue scale) after 48-96 h and after 3 months, Rate of further interventions for pulmonary embolism during admission (embolectomy, full dose thrombolysis, mechanical ventilation, need for vasopressors, cardiopulmonary resuscitation, VA-ECMO etc.), Mortality in the three arms (log-rank), and hazard ratio in multivariable analysis using the UFH/LMWH as reference., Incidence of tricuspid regurgitation (TR) gradient > 40 mmHg at 3 months follow-up echocardiography, Six-minute walking distance (6MWD) at 3 months follow-up comparing the three groups, Quality of life (PEmbQoL) at 3 months follow-up comparing the three groups

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026