Nectero EAST System Clinical Study

Abdominal Aortic Aneurysm Clinical Trial

— stAAAble  

Official title:

Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001918
• Other study ID #: EAST002
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 25, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Nectero Medical, Inc.
• Contact: Charlene Knape
• Phone: 866-755-4744
• Email: cknape[@]necteromedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2029
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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:

1. 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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Drug:
• Nectero EAST System
Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.

Locations

Country	Name	City	State
United States	University of Michigan Health	Ann Arbor	Michigan
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	University of Chicago	Chicago	Illinois
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Prime Vascular Institute	Delray Beach	Florida
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Medical Campus Inova Health Systems	Fairfax	Virginia
United States	University of Florida	Gainesville	Florida
United States	Prisma Health	Greenville	South Carolina
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Miami Vascular Institute Baptist Health	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Beaumont Health	Royal Oak	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Honor Health Scottsdale Shea Medical Center	Scottsdale	Arizona
United States	University of Washington at Harborview Medical Center	Seattle	Washington
United States	North Central Heart - A Division of Avera Heart Hospital	Sioux Falls	South Dakota
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Nectero Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cheng SWK, Eagleton M, Echeverri S, Munoz JG, Holden AH, Hill AA, Krievins D, Ramaiah V. A pilot study to evaluate a novel localized treatment to stabilize small- to medium-sized infrarenal abdominal aortic aneurysms. J Vasc Surg. 2023 Oct;78(4):929-935.e1. doi: 10.1016/j.jvs.2023.05.056. Epub 2023 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint	The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).	24 months
Secondary	Growth	The growth over time in aneurysm diameter based on CT core laboratory readings.	24 months

External Links

•   J Vasc Surg. Pilot Study