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Peripheral Arterial DiseaseJETARTNCT06434779

Investigating Efficacy and Safety of JETi® in Arterial Occlusions in FEM-POP and Prox BTK-Lesions (JETART)

A study testing JETi 6F and 8F Thrombectomy system in people with Peripheral Arterial Disease, run by Vascular Science LP GmbH.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
JETi 6F and 8F Thrombectomy system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
Jul 2024to May 2026
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient is ≥18 years
  • Patient has Rutherford Classification 2,3 or 4.
  • Patient has provided written informed consent and is willing to comply with study follow-up requirements.
  • Angiographic inclusion criteria
  • De novo thrombotic occlusive lesion(s) or thrombotic re-occlusion or in-stent thrombotic occlusive lesion(s) or thrombotic occlusion of a bypass (autolog or prosthetic) occurring acute or subacute with onset of complains within <30 days prior to first seen by investigating physician.
  • Target lesion is located between the ostium of the SFA and the end of the P3 segment of the popliteal artery, tibioperoneal trunk, respectively the first 10 cm of the below the knee vessels
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  • Target vessel diameter ≥ 3 mm and ≤ 8 mm and irrespective of lesion length
  • Target lesion must be occlusive lesion Note: there is no limitation in lesion length
  • Successful, uncomplicated crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limiting dissection of perforation and is judged by visual inspection to be within the true lumen.
  • A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography.
  • At least one patent native distal outflow artery to the ankle or foot, free from significant stenosis (≥ 50 % stenosis) as confirmed by angiography.

Who cannot join

  • Patients meets any contraindication for JETi mechanical thrombectomy use per IFU
  • Lesion crossing is difficult and the lesion is not suspicious for fresh thrombus containment
  • Pregnant women or female patients of childbearing potential that do not use adequate contraceptive methods
  • Patient has a life expectancy of less than 1 year
  • Patient has a known allergy to contrast medium that cannot be adequately pre-medicated.
  • Patient is allergic to all anti-platelet treatments
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  • Patient has platelet count <100.000/mm3 or >700.000/mm
  • Patient has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure
  • Patient is diagnosed with coagulopathy that bares the risk of increased bleeding risk
  • Patient has history of stroke within past 90 days
  • Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study.
  • Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure
  • Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol
  • Patient suffering from HIT II
  • Angiographic Exclusion Criteria:
  • Target lesion is larger than 8 mm, respectively smaller than 3 mm
  • Significant target vessel tortuosity or other parameters prohibiting access to the target lesion
  • Absence of thrombus in the target vessel
  • Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤ 30 % residual diameter stenosis without death or major complications.
  • No patent outflow vessels on the level of 10 cm below the origin of below the-knee arteries to the level of the foot or ankle.

About this study

Official title: Single Arm, Multicenter, Prospective Registry Investigating Efficacy and Safety of Mechanical Thrombectomy (JETi®) in Acute and Acute-on-Chronic Arterial Occlusions in Femoro-popliteal and Proximal BTK-Lesions (JETART)

To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.

Being tested
JETi 6F and 8F Thrombectomy system
Medical subject headings
Peripheral Arterial Disease

What participants receive

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

  • JETi 6F and 8F Thrombectomy systemDevice

    To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.

Study groups in NCT06434779
Study groupRoleWhat they receive
Mechanical Thrombectomy (JETi®)ExperimentalNot described
Receives: Device: JETi 6F and 8F Thrombectomy system

What is being measured

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

  1. Primary Efficacy Endpoint

    The primary efficacy endpoint is technical procedural success (post Jeti) defined as restoration of impaired flow to a straight-line orthograde flow in the target vessel/bypass with near complete or complete recanalization of occluded vessel by using the JETI system prior to further additional endovascular therapy.

    Measured: During index procedure

  2. Primary Safety Endpoint

    The primary safety endpoint is a composite of

    1. freedom from device- and procedure-related death through 30 days post-index procedure;
    2. freedom from major target limb amputation (above-the-ankle (ATA)) through 30 days post-procedure and
    3. freedom from clinically-driven target vessel revascularization (CD-TVR) through 30 days post-index procedure

    Measured: Up to 30 days post-index procedure

Secondary outcomes (10)

  1. Acute device success

    Defined as successful delivery of the device to the lesion

    Measured: During index procedure

  2. Secondary safety endpoint at discharge up to 30 days post index procedure

    Secondary safety endpoint is a composite of

    1. freedom from Major Adverse Events (MAEs). MAEs are defined as: all-cause death; bleeding, hematoma and intracranial hemorrhage; major target limb amputation; thrombosis at the target lesion.
    2. freedom from major target limb amputation and MALE
    3. freedom from CD-TVR

    Measured: Up to 30 days

  3. Sustained clinical improvement at discharge and at 30- days post-index procedure

    Clinical improvement is defined as a composite of

    1. freedom from major target limb amputation,
    2. freedom from TVR,
    3. freedom from worsening target limb Rutherford class (compared to baseline)
    4. freedom from decrease in target limb ankle brachial index (ABI) ≥0.15 (compared to baseline)

    Measured: Hospital admission to discharge up to 30 days and at 30 days

  4. Primary Patency at discharge and at 30 days post-index procedure

    The primary patency is defined as a composite of

    1. freedom from clinically-driven target lesion revascularization (CD-TLR)
    2. freedom from binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis) as confirmed by an independent Corelab

    Measured: Hospital admission to discharge up to 30 days and at 30 days

  5. Freedom from TLR at discharge and at 30 days post-index procedure

    TLR is defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure

    Measured: Hospital admission to discharge up to 30 days and at 30 days

  6. Change in target limb Rutherford Classification from baseline to 30 days post-index procedure

    Change in target limb Rutherford Classification from baseline to 30 days post-index procedure

    Measured: Up to 30 days

  7. Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure

    Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure

    Measured: Up to 30 days

  8. Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure

    Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure

    Measured: Up to 30 days

  9. Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure

    Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure

    Measured: Up to 30 days

  10. Duration of hospital stay

    Duration of hospital stay

    Measured: Hospital admission to discharge up to 30 days

Timeline

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

  1. First posted30 May 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06434779
Sponsor's protocol ID
iD320240306
Acronym
JETART
Status last verified
Jul 2024
First submitted
6 Mar 2024
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD sharing plan

Questions about this trial

What is this clinical trial studying?

A study testing JETi 6F and 8F Thrombectomy system in people with Peripheral Arterial Disease, run by Vascular Science LP GmbH.

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 11 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Primary Efficacy Endpoint (time frame: During index procedure). 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 NCT06434779.

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 Jul 2024.

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