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Pulmonary EmbolismPhase 2ART-MPENCT00780767

Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism

A Phase 2 study testing ANGIOJET RHEOLYTIC THROMBECTOMY in people with Pulmonary Embolism, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
What is being tested?
ANGIOJET RHEOLYTIC THROMBECTOMY
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSwitzerland
Study dates
Sep 2008to Oct 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Univesity hospital of geneva

    Geneva, Canton of Geneva, 1211

Other trials in Switzerland

About this study

Official title: Angiojet Rheolytic Thrombectomy In Case of Massive Pulmonary Embolism A Prospective Single Center Feasibility and Safety Pilot Trial

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.

Read the 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.

The angiojet rheolytic thrombectomy (ART) catheter (Angiojet : Possis medical ; Minneapolis, MN, USA) utilizes high velocity saline jets for thrombus aspiration, maceration and evacuation through the Bernoulli principle. Nowadays this technology is successfully utilized daily in the coronary and peripheral artery fields (i.e. thrombus aspiration during coronary or arterial angioplasty).

Due to its safety and efficacy, demonstrated in randomized trials including patients with coronary artery disease, several recent reports also confirmed the usefulness of this ART also in extra-coronary domain (peripheral arterial and venous diseases).

Massive PE, as the thrombotic coronary artery occlusion, is a life threatening clinical manifestation, therefore several centers began to manage it associating mechanical (i.e.ART) clot removal and pharmacological (i.e. lysis).

The first small, retrospective non randomized series suggest the safety and efficacy of this technology, confirming its feasibility compared with the actual proposed treatment of MPE (i.e. i.v. or in-situ pulmonary thrombolysis).

The first in man utilization of the Angiojet rheolytic thrombectomy for treating acute massive PE dates 1997, however in-vitro tests also revealed that Angiojet is able to successfully remove thrombus up to 14 days old, thus enlarging its usefulness also in sub-acute cases (i.e.>14 days old thrombus).

Despite the fact that indication of an i.v. fibrinolysis is worldwide accepted in case of MPE and that established lysis protocols are nowadays available, mortality remains unacceptably high (up to 30%) and bleeding related morbidity a major concern. In fact in large PE registries, up to 20% of the patients experienced major bleedings complications, and in 3% of the cases this was intracranial.

Of interest in case of sub-massive PE (sub-MPE), which is also associated with a quite high mortality (up to 8%) some disagreement concerning the best treatment modality still persists. Several authors support an intensive treatment modality favourizing the systemic i.v. thrombolysis; however, others suggest a more conservative attitude (anticoagulation alone with fibrinolysis only in case of clinical deterioration). These cases of sub-MPE may be very challenging, because an established consensus of the definition of sub-MPE combining clinical, radiological and cardiological criteria are still lacking. Furthermore the thrombolytic regimen is not complication-free, suggesting that, before performing an i.v. thrombolysis, the physician in charge of the patient has to seriously take in consideration all the absolute and the relative contra-indications of such a treatment. (i.e.recent surgery, active peptic ulcer, intra-cerebral bleeding, pregnancy, neoplasm, see Table 1).

The ongoing debate on how to improve mortality in patients with MPE and concerning the correct managing of patients with sub-MPE suggests that in both cases, there is an urgent need of improving the actual treatment modalities.

Being tested
ANGIOJET RHEOLYTIC THROMBECTOMY
Keywords
angiojet, massive pulmonary embolism, RHEOLYTIC THROMBECTOMY, patients presenting with massive pulmonary embolism
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANGIOJET RHEOLYTIC THROMBECTOMYDevice

    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.

Study groups in NCT00780767
Study groupRoleWhat they receive
Thrombectomy armExperimentalNot described
Receives: Device: ANGIOJET RHEOLYTIC THROMBECTOMY

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 month

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

    Measured: 1 month

Secondary outcomes (3)
  1. Improve the clinical, haemodynamic and the radiological issues of the treated patients

    Measured: 1 month

  2. Evaluate the clinical status, and the echocardiographic parameters at 3 months

    Measured: 1 month

  3. Analyze the technical aspect of the ART procedure

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00780767
Sponsor's protocol ID
Angiojet in MPE
Acronym
ART-MPE
Status last verified
Oct 2008
First submitted
27 Oct 2008
Last updated
16 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18178417
  • 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.

    PubMed 23680957

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ANGIOJET RHEOLYTIC THROMBECTOMY in people with Pulmonary Embolism, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successfully perform an ART in all patients presenting a MPE = technical feasibility of ART (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00780767, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.

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