The ArtixASCEND Study
Purpose
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.
Condition
- Acute Lower Limb Arterial Occlusion
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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 - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Artix Thrombectomy System |
Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System. |
|
Recruiting Locations
Yale University
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Contact:
Edouard Aboian, MD
Edouard Aboian, MD
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
Contact:
Kyle Reynolds, MD
Kyle Reynolds, MD
Ascension Sacred Heart Pensacola
Pensacola, Florida 32504
Pensacola, Florida 32504
Contact:
Rohit Amin, MD
Rohit Amin, MD
Terrebonne General Hospital/Cardiovascular Institute of the South
Houma, Louisiana 70360
Houma, Louisiana 70360
Contact:
Pradeep Nair, MD
Pradeep Nair, MD
Mass General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Contact:
Anahita Dua, MD
Anahita Dua, MD
MyMichigan Health
Midland, Michigan 48670
Midland, Michigan 48670
Contact:
Jacob Frisbie, DO
Jacob Frisbie, DO
Cooper University Hospital
Camden, New Jersey 08103
Camden, New Jersey 08103
Contact:
Bruce Tjaden Jr, MD
Bruce Tjaden Jr, MD
Mission Memorial Hospital
Asheville, North Carolina 28801
Asheville, North Carolina 28801
Contact:
John Henretta, MD
John Henretta, MD
Aultman Hospital
Canton, Ohio 44710
Canton, Ohio 44710
Contact:
Jeffrey Prem, MD
Jeffrey Prem, MD
The Christ Hospital
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Contact:
Christopher Paprzycki, MD
Christopher Paprzycki, MD
Ascension St. John Jane Phillips Medical Center
Bartlesville, Oklahoma 74006
Bartlesville, Oklahoma 74006
Contact:
Anderson Mehrle, MD
Anderson Mehrle, MD
Saint Francis Hospital
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
Contact:
Andres Andres Guerra, MD
Andres Andres Guerra, MD
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Contact:
Satish Muluk, MD
Satish Muluk, MD
Grand Strand Medical Center
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
Contact:
Christian Salinas, MD
Christian Salinas, MD
Spartanburg Regional Health System
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Contact:
Scott Silver, MD
Scott Silver, MD
TriStar Centennial Medical Center
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Allen Lee, MD
Allen Lee, MD
Bellin Health
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Contact:
Sumit Ringwala, MD
Sumit Ringwala, MD
More Details
- Status
- Recruiting
- Sponsor
- Inari Medical