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

NCT06434779 | Not Yet Recruiting DMC

• 1 other identifier: iD320240306
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  During index procedure

• 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

  Up to 30 days post-index procedure

Secondary Outcomes (10)

• Acute device success

  During index procedure

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

  Up to 30 days

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

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

• Primary Patency at discharge and at 30 days post-index procedure

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

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

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

Study Arms (1)

Mechanical Thrombectomy (JETi®)

EXPERIMENTAL

Device: JETi 6F and 8F Thrombectomy system

Interventions

JETi 6F and 8F Thrombectomy system DEVICE

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.

Mechanical Thrombectomy (JETi®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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.

You may not qualify if:

• 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
• 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
• Target lesion is larger than 8 mm, respectively smaller than 3 mm

Sponsors & Collaborators

• Vascular Science LP GmbH: lead
• ID3 Medical: collaborator
• Abbott: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: May 30, 2024
• Study Start: July 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share