RECRUITING

Nectero EAST System Clinical Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2023-10-25

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06001918

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Charlene Knape

CONTACT

866-755-4744

cknape@necteromedical.com

Tracy Roberts

CONTACT

(303)3964603

troberts@necteromedical.com

Principal Investigator

Daniel Clair, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Grace Wang, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Honor Health Scottsdale Shea Medical Center

Scottsdale, Arizona, 85258

United States

San Francisco VA Medical Center

San Francisco, California, 94121

United States

University of Colorado

Aurora, Colorado, 80045

United States

Medstar Washington Hospital Center

Washington, District of Columbia, 20010

United States

Prime Vascular Institute

Delray Beach, Florida, 33446

United States

University of Florida

Gainesville, Florida, 32610

United States

Miami Vascular Institute Baptist Health

Miami, Florida, 33176

United States

Medical College of Georgia

Augusta, Georgia, 30912

United States

University of Chicago

Chicago, Illinois, 60637

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

University of Massachusetts

Worcester, Massachusetts, 01655

United States

University of Michigan Health

Ann Arbor, Michigan, 48109

United States

Beaumont Health

Royal Oak, Michigan, 48073

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766

United States

University of Rochester

Rochester, New York, 14642

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

University Hospitals Cleveland

Cleveland, Ohio, 44106

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

Ohio Health Riverside

Columbus, Ohio, 43214

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Portland VA Medical Center

Portland, Oregon, 97239

United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Jefferson Clinical Research Institute

Philadelphia, Pennsylvania, 19107

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219

United States

Prisma Health

Greenville, South Carolina, 29605

United States

North Central Heart - A Division of Avera Heart Hospital

Sioux Falls, South Dakota, 57108

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Houston Healthcare

Houston, Texas, 77004

United States

Baylor Scott & White Medical Center

Plano, Texas, 75093

United States

University of Utah Hospital

Salt Lake City, Utah, 84132

United States

Inova Fairfax Medical Campus Inova Health Systems

Fairfax, Virginia, 22031

United States

University of Washington at Harborview Medical Center

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: Nectero Medical, Inc.

Daniel Clair, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center
Grace Wang, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-25

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2023-10-25

Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

Abdominal Aortic Aneurysm

Additional Relevant MeSH Terms

Abdominal Aortic Aneurysm