Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism (ART-MPE)
This study has been completed.
Information provided by (Responsible Party):
Robert F Bonvini, University Hospital, Geneva
First received: October 27, 2008
Last updated: August 15, 2012
Last verified: October 2008
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.
Device: ANGIOJET RHEOLYTIC THROMBECTOMY
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Angiojet Rheolytic Thrombectomy In Case of Massive Pulmonary Embolism A Prospective Single Center Feasibility and Safety Pilot Trial
Primary Outcome Measures:
- Successfully perform an ART in all patients presenting a MPE = technical feasibility of ART [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- No major device-related complications, no major procedure-related complications = safety of ART [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Improve the clinical, haemodynamic and the radiological issues of the treated patients [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Evaluate the clinical status, and the echocardiographic parameters at 3 months [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Analyze the technical aspect of the ART procedure [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2011 (Final data collection date for primary outcome measure)
Experimental: Thrombectomy arm
Device: ANGIOJET RHEOLYTIC THROMBECTOMY
The Angiojet catheter is a double lumen catheter percutaneously introduced via the common femoral vein into the main pulmonary trunk or the affected pulmonary artery respectively. One lumen serves to deliver high pressure saline jets into the thrombus and the other effluent lumen serves for clot removal utilizing a localized pressure region (Venturi effect) that attracts the thrombus for fragmentation into small particles. The fragmented debris are then pushed out through the evacuation line as a result of the retrograde high pressure saline jets, finally transporting them into a collection bag.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780767
|Univesity hospital of geneva
|Geneva, GE, Switzerland, 1211 |
University Hospital, Geneva
||Robert F Bonvini, MD, University Hospital, Geneva
History of Changes
|Other Study ID Numbers:
||Angiojet in MPE
|Study First Received:
||October 27, 2008
||August 15, 2012
||Switzerland: Ethical committee university Hospital of Geneva
Keywords provided by University Hospital, Geneva:
massive pulmonary embolism
patients presenting with massive pulmonary embolism
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Embolism and Thrombosis
Respiratory Tract Diseases