Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism (ART-MPE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert F Bonvini, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00780767
First received: October 27, 2008
Last updated: August 15, 2012
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Pulmonary Embolism
Device: ANGIOJET RHEOLYTIC THROMBECTOMY
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Angiojet Rheolytic Thrombectomy In Case of Massive Pulmonary Embolism A Prospective Single Center Feasibility and Safety Pilot Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

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 ]

Enrollment: 10
Study Start Date: September 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00780767

Locations
Switzerland
Univesity hospital of geneva
Geneva, GE, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert F Bonvini, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00780767     History of Changes
Other Study ID Numbers: Angiojet in MPE
Study First Received: October 27, 2008
Last Updated: August 15, 2012
Health Authority: Switzerland: Ethical committee university Hospital of Geneva

Keywords provided by University Hospital, Geneva:
angiojet
massive pulmonary embolism
RHEOLYTIC THROMBECTOMY
patients presenting with massive pulmonary embolism

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014