Acute Lower Limb Arterial OcclusionNCT07135895
The ArtixASCEND Study
A study testing Artix Thrombectomy System in people with Acute Lower Limb Arterial Occlusion, run by Inari Medical at 23 sites in United States.
Trial summary
This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lower Limb Arterial Occlusion
- What is being tested?
- Artix Thrombectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 23 sitesUnited States
- Study dates
- 7 Jan 2026to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Acute symptom duration ≤ 14 days
- Lower limb arterial occlusion below inguinal ligament
- Target lesion in native vessel
- Target vessel size between 3 mm and 8 mm by visual estimation
- Rutherford category I, IIa, or IIb
- Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements
Who cannot join
- Life expectancy < 6 months
- Prior major amputation in the target limb
- Prior minor amputation in the target limb that is not completely healed or cannot bear weight
- Non-thrombotic occlusion secondary to dissection, vasculitis, or target vessel trauma
- Treatment of the index event in the target vessel with any other endovascular thrombectomy/aspiration or open surgical method prior to Artix procedure
- Part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
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- Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
- Unable to tolerate antiplatelet therapy
- Inability to anticoagulate the patient with heparin, enoxaparin or other parenteral antithrombin, or known to have uncorrected bleeding disorders (e.g., gastro-intestinal ulcer, menorrhagia, liver failure, heparin-induced thrombocytopenia (HIT))
- Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of Artix per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments)
- Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 23 recruiting
- Recruiting
Mission Memorial Hospital
Asheville, North Carolina, 28801
John Henretta, MD
- Recruiting
Ascension St. John Jane Phillips Medical Center
Bartlesville, Oklahoma, 74006
Anderson Mehrle, MD
- Recruiting
Mass General Hospital
Boston, Massachusetts, 02114
Anahita Dua, MD
- Recruiting
NYP-Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Rajesh K Malik, MD
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Bruce Tjaden Jr, MD
- Recruiting
Aultman Hospital
Canton, Ohio, 44710
Jeffrey Prem, MD
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Christopher Paprzycki, MD
- Recruiting
Bellin Health
Green Bay, Wisconsin, 54301
Sumit Ringwala, MD
- Recruiting
Terrebonne General Hospital/Cardiovascular Institute of the South
Houma, Louisiana, 70360
Pradeep Nair, MD
- Recruiting
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
Kristofer Charlton-Ouw, MD
- Recruiting
MyMichigan Health
Midland, Michigan, 48670
Jacob Frisbie, DO
- Recruiting
Grand Strand Medical Center
Myrtle Beach, South Carolina, 29572
Christian Salinas, MD
- Recruiting
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Allen Lee, MD
- Recruiting
Yale University
New Haven, Connecticut, 06510
Edouard Aboian, MD
- Recruiting
Mount Sinai Medical Center NY
New York, New York, 10025
Michael Dudkiewicz, MD
- Recruiting
Ascension Sacred Heart Pensacola
Pensacola, Florida, 32504
Rohit Amin, MD
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Satish Muluk, MD
- Recruiting
Vassar Brothers Medical Center/Nuvance Health
Poughkeepsie, New York, 12601
Zachary Matthay, MD
- Recruiting
California Pacific Medical Center Van Ness/Sutter Health
San Francisco, California, 94109
Hernan Bazan, MD
- Recruiting
Spartanburg Regional Health System
Spartanburg, South Carolina, 29303
Scott Silver, MD
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Angela Kokkosis, MD
- Recruiting
Saint Francis Hospital
Tulsa, Oklahoma, 74136
Andres Andres Guerra, MD
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Kyle Reynolds, MD
About this study
Official title: The Artix All-in-one Solution for Complete thrombEctomy With eNDovascular Approach
This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
- Conditions
- Acute Lower Limb Arterial Occlusion
- Being tested
- Artix Thrombectomy System
- Keywords
- Acute Limb Ischemia, Lower limb arterial occlusion, Artix Thrombectomy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artix Thrombectomy SystemDevice
Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System.
| Study group | Role | What they receive |
|---|---|---|
| Artix Thrombectomy System | Experimental | Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System. Receives: Device: Artix Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Revascularization rate post-index procedure of target treatment area determined by an independent core lab.
Measured: Immediately Following Index Procedure
Primary Safety Endpoint
Periprocedural (within 48 hours) Artix Thrombectomy System-related major bleeding rate adjudicated as causal to the study device as determined by an independent Medical Monitor.
Measured: 48 Hours
Secondary outcomes (4)
Distal embolization SAEs
Measured: Intra-procedure
All-cause mortality
Measured: 1-month follow-up visit
Limb salvage
Freedom from major amputation of the index limb
Measured: 1-month follow-up visit
Amputation-free survival
Freedom from major amputation and all-cause mortality
Measured: 1-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start7 Jan 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lower Limb Arterial OcclusionStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott T Lewis, Study director, Inari MedicalAnahita Dua, MD, Principal investigator, Massachusetts General HospitalShang Loh, MD, Principal investigator, Penn Presbyterian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135895
- Sponsor's protocol ID
- 25-001
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Artix All-in-one Solution for Complete thrombEctomy With eNDovascular Approach
- ClinicalTrials.gov ID
- NCT07135895
- Acronym / sponsor ID
- 25-001
- Conditions
- Acute Lower Limb Arterial Occlusion
- Keywords
- Acute Limb Ischemia, Lower limb arterial occlusion, Artix Thrombectomy System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Inari MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 22 Aug 2025 (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 a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artix Thrombectomy System | Experimental | Device: Artix Thrombectomy SystemNon-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Acute symptom duration ≤ 14 days
- Lower limb arterial occlusion below inguinal ligament
- Target lesion in native vessel
- Target vessel size between 3 mm and 8 mm by visual estimation
Key exclusion criteria (11 listed)
- Life expectancy < 6 months
- Prior major amputation in the target limb
- Prior minor amputation in the target limb that is not completely healed or cannot bear weight
- Non-thrombotic occlusion secondary to dissection, vasculitis, or target vessel trauma
- Treatment of the index event in the target vessel with any other endovascular thrombectomy/aspiration or open surgical method prior to Artix procedure
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 |
|---|---|---|
| Artix Thrombectomy SystemTreatment of lower extremity arterial occlusions using the Artix Thrombectomy System. | Device | Artix Thrombectomy System |
Primary outcome
Primary Effectiveness Endpoint
Time frame: Immediately Following Index Procedure
Revascularization rate post-index procedure of target treatment area determined by an independent core lab.
Primary Safety Endpoint
Time frame: 48 Hours
Periprocedural (within 48 hours) Artix Thrombectomy System-related major bleeding rate adjudicated as causal to the study device as determined by an independent Medical Monitor.
4 secondary outcomes
Distal embolization SAEs
Time frame: Intra-procedure
All-cause mortality
Time frame: 1-month follow-up visit
Limb salvage
Time frame: 1-month follow-up visit
Amputation-free survival
Time frame: 1-month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- 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.
Scott T Lewis study director
Inari Medical
Anahita Dua, MD principal investigator
Massachusetts General Hospital
Shang Loh, MD principal investigator
Penn Presbyterian Medical Center
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artix Thrombectomy System in people with Acute Lower Limb Arterial Occlusion, run by Inari Medical at 23 sites in United States.
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 11 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Allen (651-279-8587, james.allen2@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: Immediately Following 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?
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 Oct 2026.