Angiojet Rheolytic Thrombectomy In Case of Massive Pulmonary Embolism A Prospective Single Center Feasibility and Safety Pilot Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University Hospital, Geneva
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Successfully perform an ART in all patients presenting a MPE = technical feasibility of ART
Study Overview
Brief Summary
This pilot study is mainly aimed to evaluate the feasibility and safety of the percutaneous Angiojet Rheolytic Thrombectomy (ART) in patients presenting a MPE. Secondarily the effectiveness of this treatment modality will also be estimated.
Detailed Description
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 contraindications are absolute. In these quite rare cases, where thrombolytic therapy is absolutely contraindicated, a surgical thrombo-embolectomy is advised, however this kind of challenging surgery is not available world-wide and it still remains associated with a prohibitive high rate of mortality.
A less invasive alternative remains the percutaneous thrombectomy, which may further be divided into:
- Aspiration thrombectomy,
- Fragmentation thrombectomy,
- Rheloytic thrombectomy. The first transvenous percutaneous pulmonary embolectomy was performed more than 30 years ago; however, it is only recently that, thanks to new developed technologies, phyisicians manifest an increased interest in developing this promising less invasive procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged >18 years old
- •Patients presenting a MPE (i.e. hemodynamically unstable at moment of the inclusion (i.e. shock index (SI) >1).
- •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
- •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
- •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.
- •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).
- •Patients with sub-MPE without any other clinical or para-clinical sign of severity (e.g. haemodynamically stable = SI<1).
- •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).
- •Patient with an estimated clearance to creatinine less than 30 ml/min.
- •Patients or members of their family who refused to give their signed informed consenstement.
- •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).
- •Patients with a life expectancy of <3months for other medical pre-existing conditions.
Arms & Interventions
Thrombectomy arm
Intervention: ANGIOJET RHEOLYTIC THROMBECTOMY (Device)
Outcomes
Primary Outcomes
Successfully perform an ART in all patients presenting a MPE = technical feasibility of ART
Time Frame: 1 month
No major device-related complications, no major procedure-related complications = safety of ART
Time Frame: 1 month
Secondary Outcomes
- Improve the clinical, haemodynamic and the radiological issues of the treated patients(1 month)
- Evaluate the clinical status, and the echocardiographic parameters at 3 months(1 month)
- Analyze the technical aspect of the ART procedure(1 month)
Investigators
Robert F Bonvini
MD
University Hospital, Geneva