Pulmonary EmbolismNCT04949048
Evaluation of the Safety and Performance of Magneto PE Kit
A study testing Magneto PE Kit in people with Pulmonary Embolism, run by Magneto Thrombectomy Solutions at 5 sites in 3 countries.
Trial summary
This study is designed as a prospective, multi-center, multinational open labeled, single armed study to evaluate the safety and performance of the Magneto PE Kit. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Magneto PE Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 26 Aug 2021to 21 Dec 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of PE
- RV/LV ratio ≥ 0.9
- Heart rate <130 BPM prior to procedure
- Subject medically eligible for interventional procedure
- Age ≥ 18 and <75 years
- Consent process is completed
Who cannot join
- Thrombolytic use within 14 days
- Known bleeding diathesis or coagulation disorder
- Any contraindication to systemic therapeutic doses of heparin or other anticoagulants
- Hemodynamic collapse at presentation
- Decompensated heart failure
- Presence of Extra-Corporeal Membrane Oxygenation.
Show all 30Show fewer
- Major trauma ISS> 15 within 14 days
- Cardiovascular or pulmonary surgery within last 7 days
- FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- Hematocrit < 28%
- Platelets < 100,000/µL
- Serum creatinine > 1.8 mg/dL
- INR>2
- Left bundle branch block
- PAP > 70 mmHg m
- Imaging evidence suggests subject is not appropriate for mechanical thrombectomy
- Presence of intracardiac lead in right ventricle or atrium.
- Pacemaker or Implantable Cardioverter Defibrillator
- Presence of intracardiac thrombus
- Anaphylactic reaction to radiographic contrast agents that cannot be pre-treated
- Known right- to-left shunt,
- Known left ventricular ejection fraction ≤ 30%
- History of severe chronic pulmonary arterial hypertension
- History of underlying lung disease with oxygen dependence
- History of chest irradiation
- History of Heparin Induced Thrombocytopenia (HIT)
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study
- Life expectancy of < 90 days as determined by the investigator
- Subjects who are intubated
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Israel2 sites
Hadassah Ein Karem Hospital
Jerusalem
Sheba Medical Center
Ramat Gan
About this study
Official title: Evaluation of the Safety and Performance of Magneto PE Kit for Endovascular Thrombectomy in Patients With Acute Pulmonary Embolism
This study is designed as a prospective, multi-center, multinational open labeled, single armed study to evaluate the safety and performance of the Magneto PE Kit.
- Conditions
- Pulmonary Embolism
- Being tested
- Magneto PE Kit
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magneto PE KitDevice
All enrolled patients will be treated with Magneto PE Kit
| Study group | Role | What they receive |
|---|---|---|
| Magneto PE Kit | Experimental | Treatment with Magneto PE Kit Receives: Device: Magneto PE Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety of Magneto PE Kit
Number of patients with a composite of major adverse events within 48 (± 8) hours of the index procedure
Measured: 48 (±8) hours
Secondary outcomes (3)
Assessment of the safety of Magneto PE Kit
Number of patients with a composite of major adverse events within 30 (± 3) days of the index procedure
Measured: 30 (±3) days
Assessment of ease of use during the procedure
Ease of use of Magneto PE Kit as assessed by a subjective questionnaire to be completed by the primary operator after the procedure
Measured: Procedure
Assessment of the impact on RV dysfunction (RV/LV ratio)
RV/LV ratio assessment at 48 (±8) hours
Measured: 48 (±8) hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start26 Aug 2021
- Primary completion22 Nov 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magneto Thrombectomy Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949048
- Sponsor's protocol ID
- KT1-CLN001
- Status last verified
- Mar 2024
- First submitted
- 3 Jan 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersen A, Musialek P, Araszkiewicz A, Schultz J, Nielsen-Kudsk JE, Tekieli L, Zajdel W, Slawek-Szmyt S, Taff Y, Weinberg I. First-in-Human Trial of Mechanical-Electric Thrombectomy in Acute Pulmonary Embolism. JACC Cardiovasc Interv. 2023 Mar 13;16(5):623-625. doi: 10.1016/j.jcin.2022.12.021. Epub 2023 Feb 8. No abstract available.
PubMed 36922052
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of Magneto PE Kit for Endovascular Thrombectomy in Patients With Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT04949048
- Acronym / sponsor ID
- KT1-CLN001
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Magneto Thrombectomy SolutionsIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a prospective, multi-center, multinational open labeled, single armed study to evaluate the safety and performance of the Magneto PE Kit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magneto PE Kit | Experimental | Device: Magneto PE KitTreatment with Magneto PE Kit |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of PE
- RV/LV ratio ≥ 0.9
- Heart rate <130 BPM prior to procedure
Key exclusion criteria (30 listed)
- Thrombolytic use within 14 days
- Known bleeding diathesis or coagulation disorder
- Any contraindication to systemic therapeutic doses of heparin or other anticoagulants
- Hemodynamic collapse at presentation
- Decompensated heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magneto PE KitAll enrolled patients will be treated with Magneto PE Kit | Device | Magneto PE Kit |
Primary outcome
Assessment of the safety of Magneto PE Kit
Time frame: 48 (±8) hours
Number of patients with a composite of major adverse events within 48 (± 8) hours of the index procedure
3 secondary outcomes
Assessment of the safety of Magneto PE Kit
Time frame: 30 (±3) days
Assessment of ease of use during the procedure
Time frame: Procedure
Assessment of the impact on RV dysfunction (RV/LV ratio)
Time frame: 48 (±8) hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 36922052Andersen A, Musialek P, Araszkiewicz A, Schultz J, Nielsen-Kudsk JE, Tekieli L, Zajdel W, Slawek-Szmyt S, Taff Y, Weinberg I. First-in-Human Trial of Mechanical-Electric Thrombectomy in Acute Pulmonary Embolism. JACC Cardiovasc Interv. 2023 Mar 13;16(5):623-625. doi: 10.1016/j.jcin.2022.12.021. Epub 2023 Feb 8. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magneto PE Kit in people with Pulmonary Embolism, run by Magneto Thrombectomy Solutions at 5 sites in 3 countries.
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 8 inclusion and 30 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, Poland, Denmark. 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.
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?
Assessment of the safety of Magneto PE Kit (time frame: 48 (±8) hours). 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 NCT04949048, which also lists 1 linked publication.
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 13 Mar 2024.