Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism

NCT00780767 | Completed Phase 2

• 1 other identifier: Angiojet in MPE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Keywords

angiojet; massive pulmonary embolism; RHEOLYTIC THROMBECTOMY; patients presenting with massive pulmonary embolism

Outcome Measures

Primary Outcomes (2)

• Successfully perform an ART in all patients presenting a MPE = technical feasibility of ART

  1 month

• No major device-related complications, no major procedure-related complications = safety of ART

  1 month

Secondary Outcomes (3)

• 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

Study Arms (1)

Thrombectomy arm

EXPERIMENTAL

Device: ANGIOJET RHEOLYTIC THROMBECTOMY

Interventions

ANGIOJET RHEOLYTIC THROMBECTOMY DEVICE

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.

Thrombectomy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>18 years old
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Univesity hospital of geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (2)

• Margheri M, Vittori G, Vecchio S, Chechi T, Falchetti E, Spaziani G, Giuliani G, Rovelli S, Consoli L, Biondi Zoccai GG. Early and long-term clinical results of AngioJet rheolytic thrombectomy in patients with acute pulmonary embolism. Am J Cardiol. 2008 Jan 15;101(2):252-8. doi: 10.1016/j.amjcard.2007.07.087.

  PMID: 18178417 RESULT

• Bonvini RF, Roffi M, Bounameaux H, Noble S, Muller H, Keller PF, Jolliet P, Sarasin FP, Rutschmann OT, Bendjelid K, Righini M. AngioJet rheolytic thrombectomy in patients presenting with high-risk pulmonary embolism and cardiogenic shock: a feasibility pilot study. EuroIntervention. 2013 Apr 22;8(12):1419-27. doi: 10.4244/EIJV8I12A215.

  PMID: 23680957 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 28, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 16, 2012

Record last verified: 2008-10

Locations

CH (1)