Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism
Launched by UNIVERSITY HOSPITAL, GENEVA · Oct 27, 2008
Trial Information
Current as of May 15, 2025
Completed
Keywords
ClinConnect Summary
Pulmonary embolism (PE) is a major cause of mortality and morbidity in our society with more than 150.000 deaths every year in the US. Usually mortality occurs in the first hour after symptoms onset (up to 11%) and may further increase up to 17% at 3 months follow-up.
In case of massive PE (MPE) mortality dramatically increases up to 30% despite important improvements recently made in precocious diagnosis and aggressive medical treatments (i.e. i.v. thrombolysis).
Quite often (up to 40%) in case of PE there is at least one relative fibrinolysis contraindication, and less frequently these ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patients aged \>18 years old
- • 2. Patients presenting a MPE (i.e. hemodynamically unstable at moment of the inclusion (i.e. shock index (SI) \>1).
- • 3. Patients where a hemodynamic stability (SI=1) is hardly obtained despite increasing dose of drug support.
- • If after 2 hours from the first medical contact where an intensive fluid substitution and cathecolamine support is begun the patient remains with a SI = 1, he/she could be included in the ART protocol.
- • If after an initial successful drug support (fluid + catecholamine) the patient represents a second episode of hemodynamic instability, he/she could be included in the ART protocol.
- • If the patient is under chronic negative chronotrope medication (e.g.beta-blockers) a SI = 1 will be sufficient to include the patient in the study
- • 4. The MPE have to be confirmed by thorax CT-scan or suspected by echocardiography (i.e.visualized thrombus on the RV or main pulmonary trunk or RV overload with a high clinical suspicion of MPE).
- Exclusion Criteria:
- • 1. Very unstable patients with life threatening MPE where the time delays to transport them in the cathterization laboratory (i.e. \<30 minutes) to perform the ART procedure is not acceptable because the systemic i.v. thrombolysis have to be immediately initiated in the emergency department.
- • 2. Patients where a percutaneous right heart catheterization via the common femoral vein is contraindicated (e.g.vascular malformation, inferior cava vein occlusion, presence of bilateral ilio-femoral thrombosis, RV or pulmonary trunk malformation).
- • 3. Patients with sub-MPE without any other clinical or para-clinical sign of severity (e.g. haemodynamically stable = SI\<1).
- • 4. Patients where the clinical evaluation estimated that the observed episode of MPE is older than 14 days (i.e. sub-acute phase with organized thrombus = ART less efficacious).
- • 5. Patient with an estimated clearance to creatinine less than 30 ml/min.
- • 6. Patients or members of their family who refused to give their signed informed consenstement.
- • 7. Patient haemodynamically very unstable where the first clinical evaluation concludes that every therapeutic effort including the ART procedure or a systemic fibrinolysis will not change the short-term prognosis of the patient (i.e. imminent death).
- • 8. Patients with a life expectancy of \<3months for other medical pre-existing conditions.
About University Hospital, Geneva
The University Hospital of Geneva is a leading academic medical center committed to advancing healthcare through innovative research and clinical excellence. Renowned for its multidisciplinary approach, the hospital integrates cutting-edge medical research with high-quality patient care, fostering a collaborative environment that encourages the translation of scientific discoveries into practical treatments. As a prominent sponsor of clinical trials, the University Hospital of Geneva is dedicated to exploring new therapies and improving patient outcomes, while adhering to the highest ethical standards and regulatory compliance. Its robust infrastructure and expert clinical teams ensure the efficient execution of trials across various medical specialties, contributing significantly to the advancement of global health initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Geneva, Ge, Switzerland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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