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History of Changes for Study: NCT06001918
Nectero EAST System Clinical Study (stAAAble)
Latest version (submitted June 14, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 14, 2023 None (earliest Version on record)
2 January 3, 2024 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 January 10, 2024 Contacts/Locations and Study Status
4 January 11, 2024 Contacts/Locations and Study Status
5 January 11, 2024 Contacts/Locations and Study Status
6 January 23, 2024 Contacts/Locations and Study Status
7 January 30, 2024 Contacts/Locations and Study Status
8 April 9, 2024 Contacts/Locations, Eligibility, Study Status, Outcome Measures and Study Description
9 May 8, 2024 Contacts/Locations and Study Status
10 June 14, 2024 Contacts/Locations and Study Status
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Study NCT06001918
Submitted Date:  August 14, 2023 (v1)

Open or close this module Study Identification
Unique Protocol ID: EAST002
Brief Title: Nectero EAST System Clinical Study (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.
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2023
Overall Status: Not yet recruiting
Study Start: October 31, 2023
Primary Completion: December 31, 2026 [Anticipated]
Study Completion: December 31, 2029 [Anticipated]
First Submitted: August 7, 2023
First Submitted that
Met QC Criteria:
August 14, 2023
First Posted: August 21, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:
August 14, 2023
Last Update Posted: August 21, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Nectero Medical, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.
Detailed Description:
Open or close this module Conditions
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Prospective, randomized, controlled trial comparing the efficacy of the treatment arm to the control arm.
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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

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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Primary Endpoint
[ Time Frame: 24 months ]

The primary endpoint is the number of participants experiencing 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).
Secondary Outcome Measures:
1. Growth
[ Time Frame: 24 months ]

The growth over time in aneurysm diameter based on CT core laboratory readings.
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Males and females ≥21 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, including severe infrarenal neck angulation.
  7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
  8. Subject has > two-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 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, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease.
  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.
Open or close this module Contacts/Locations
Central Contact Person: Charlene Knape
Telephone: 866-755-4744
Email: cknape@necteromedical.com
Study Officials: Daniel Clair, MD
Principal Investigator
Vanderbilt University Medical Center
Grace Wang, MD
Principal Investigator
University of Pennsylvania
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. PubMed 37330148
Links: Description: J Vasc Surg. Pilot Study
Available IPD/Information:

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