NCT01638468

Brief Summary

The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

Geographic Reach
4 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 1, 2016

Completed
Last Updated

December 5, 2018

Status Verified

November 1, 2018

Enrollment Period

3 years

First QC Date

July 6, 2012

Results QC Date

September 12, 2016

Last Update Submit

November 12, 2018

Conditions

Pulmonary Embolism

Keywords

Pulmonary EmbolismAcute Pulmonary EmbolismSub-massive Pulmonary EmbolismMassive Pulmonary EmbolismPulmonary Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography

    The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.

    Baseline to 24-48 hours

Secondary Outcomes (10)

  • Technical Success

    Index Procedure

  • Death - All Cause

    3 months

  • Death - Cardiac Cause

    3 months

  • Change in Systolic Pulmonary Arterial Blood Pressure

    Baseline to Post Index Procedure

  • Pulmonary Systolic Arterial Blood Pressure

    Post Index Procedure

  • +5 more secondary outcomes

Study Arms (1)

AngioJet Ultra PE Thrombectomy System

EXPERIMENTAL

Patients are treated with the AngioJet Ultra PE Thrombectomy System

Device: AngioJet Ultra PE Thrombectomy System

Interventions

AngioJet Ultra PE Thrombectomy SystemDEVICE

Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System

Also known as: AngioJet
AngioJet Ultra PE Thrombectomy System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic pulmonary embolism patients \>18 years
  • Availability of a baseline contrast-enhanced chest computed tomogram or conventional pulmonary angiogram with evidence of pulmonary embolus in at least one main or lobar pulmonary artery ≥ 6mm in diameter
  • Availability of a baseline transthoracic echocardiogram with sufficient image quality permitting the measurement of right ventricular (RV) and left ventricular (LV) dimensions in the apical or subcostal four-chamber view
  • Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV ratio ≥ 0.9 from the apical or subcostal four-chamber view
  • Appropriate informed consent was obtained from the patient or legal representative

You may not qualify if:

  • Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours
  • Patient is participating in any other clinical study
  • Pregnancy, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control)
  • Inability to comply with study Follow-up assessments (e.g. due to geographic)
  • Previous enrollment in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Universitätsklinikum Münster

Münster, Germany

Location

EO Ospedali Galliera - Genova

Genova, 16128, Italy

Location

Universita Federico II di Napoli

Napoli, 80131, Italy

Location

Ospedale S. Maria Delle Croci

Ravenna, Italy

Location

Ospedale Sant' Anna Di Como

San Fermo della Battaglia, 22020, Italy

Location

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, 4434-502, Portugal

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Angela Schutt
Organization
Boston Scientific
angela.schutt@bsci.com
763-494-2166

Study Officials

  • Nils Kucher, Prof Dr Med

    University of Bern

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 11, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 5, 2018

Results First Posted

November 1, 2016

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)IT(4)PT(1)DE(1)