Nectero EAST System Clinical Study
Purpose
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.
Condition
- Abdominal Aortic Aneurysm
Eligibility
- Eligible Ages
- Between 21 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Males and females ≥21 - ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization). 2. Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol. 3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female). 4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter. 5. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm. 6. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters. 7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive. 8. Subject has > three-year life expectancy. 9. Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years).
Exclusion Criteria
- Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm. 2. Subject has a symptomatic infrarenal abdominal aortic aneurysm. 3. Subject has a mycotic or infected aneurysm. 4. Subject has current vascular injury due to trauma. 5. Subject's aneurysm is thoracic, suprarenal or juxtarenal. 6. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm. 7. Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck of the AAA, that in the opinion of the vascular surgeon/investigator, could result in embolization of the thrombus. 8. Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries or severe infrarenal neck angulation that may compromise or does not allow delivery of the Introducer Sheath or the delivery catheter of the Nectero EAST System. 9. Subject has had a myocardial infarction within six (6) months prior to enrollment or elevated CK enzymes or troponin prior to procedure. 10. Subject has current angina, unstable angina, or other active cardiac condition such as congestive heart failure III and IV, atrial arrhythmia, ventricular arrhythmia, or valvular disease, requiring intervention. 11. Subject has undergone other major surgery within the 30 days prior to enrollment. 12. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months. 13. Known allergy to contrast material, delivery system materials (i.e., nylon, polyurethane) and/or Pentagalloyl Glucose (PGG). 14. Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta. 15. Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.). 16. Known contraindication to undergoing angiography or receiving systemic anticoagulation. 17. Subject has active systemic infection. 18. Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial). 19. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from participation in the trial and to undergo the procedures and evaluations pre- and post-treatment. 20. Subject has dialysis dependent renal failure or baseline serum creatinine level >2.5mg/dL or eGFR < 45 mL/min/1.73m2. 21. Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) which is 3 times higher than the normal upper limit; serum total bilirubin (STB) that is 1.5 times higher than the normal upper limit or has clinical evidence of jaundice. 22. Subjects that may not tolerate the lowering of their systolic blood pressure to approximately 100mmHg, should not be considered for this study or treated using the Nectero EAST System. 23. Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study. 24. Subjects with saccular AAA. 25. Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in 6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair. 26. Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Prospective, randomized, controlled trial comparing the efficacy of the treatment arm to the control arm.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- For this trial, neither the patient nor investigator will be blinded to the study group assignment. However, members of the Sponsor, the CT core laboratory and the various committees reviewing subject data, such as the Clinical Events Committee (CEC), will be blinded to the randomization and assignment arm for an individual subject under review.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Arm |
Participants assigned to the treatment arm will undergo an endovascular procedure using the Nectero EAST System to deliver the Stabilizer Infusion Solution directly inside the aneurysm. This is a one-time local delivery of the product. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years. Intervention: Drug: Stabilizer |
|
|
No Intervention Control Arm |
Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years. |
|
Recruiting Locations
Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Medstar Washington Hospital Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Prime Vascular Institute
Delray Beach, Florida 33446
Delray Beach, Florida 33446
Miami Vascular Institute Baptist Health
Miami, Florida 33176
Miami, Florida 33176
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University of Massachusetts
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
Beaumont Health
Royal Oak, Michigan 48073
Royal Oak, Michigan 48073
Washington University School of Medicine
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03766
Lebanon, New Hampshire 03766
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
University Hospitals Cleveland
Cleveland, Ohio 44106
Cleveland, Ohio 44106
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
Bethlehem, Pennsylvania 18015
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Jefferson Clinical Research Institute
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15219
Pittsburgh, Pennsylvania 15219
North Central Heart - A Division of Avera Heart Hospital
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
University of Utah Hospital
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
Inova Fairfax Medical Campus Inova Health Systems
Fairfax, Virginia 22031
Fairfax, Virginia 22031
University of Washington at Harborview Medical Center
Seattle, Washington 98104
Seattle, Washington 98104
More Details
- NCT ID
- NCT06001918
- Status
- Recruiting
- Sponsor
- Nectero Medical, Inc.