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New treatment option for Abdominal Aortic Aneurysm
Official title Nectero EAST System Clinical Study
ClinicalTrials.gov ID: NCT06001918
What this study is testing
What is Nectero EAST System?
Nectero EAST System is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for abdominal aortic aneurysm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 85
You may be able to join if
- Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
- Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete...
- Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
- Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
- Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
You likely can't join if
- Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
- Subject has a symptomatic infrarenal abdominal aortic aneurysm.
- Subject has a mycotic or infected aneurysm.
- Subject has current vascular injury due to trauma.
- Subject's aneurysm is thoracic, suprarenal or juxtarenal.
- Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
See the full eligibility criteria
Who can join
- Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
- 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.
- Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
- Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
- Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
- Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
- Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
- Subject has \> three-year life expectancy.
- 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) and blood draws.
What rules you out
- Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
- Subject has a symptomatic infrarenal abdominal aortic aneurysm.
- Subject has a mycotic or infected aneurysm.
- Subject has current vascular injury due to trauma.
- Subject's aneurysm is thoracic, suprarenal or juxtarenal.
- Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
- 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.
- 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...
- Subject has had a myocardial infarction within six (6) months prior to enrollment or elevated CK enzymes or troponin indicative of an evolving MI prior to procedure.
- 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.
- Subject has undergone other major surgery within the 30 days prior to enrollment.
- people with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
- Known allergy to contrast material that cannot be adequately premedicated, delivery system materials (i.e., nylon, polyurethane) and/or pentagalloylglucose (PGG).
- Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
- Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).
- Known contraindication to undergoing angiography or receiving systemic anticoagulation during the procedure.
- Subject has active systemic infection.
- Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).
- 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.
- Subject has dialysis dependent renal failure or baseline serum creatinine level \>2.5mg/dL or eGFR \< 45 mL/min/1.73m2.
- people with aminotransferase (ALT and/or AST) which is ≥1.5x upper limit of normal (ULN) or TB that is our of normal range for the evaluating laboratory.
- people 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.
- people that may not be able to tolerate transient occlusion of the aorta should not be considered for this study.
- people with saccular AAA.
- people 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.
- people who are not suitable for the Nectero EAST System treatment, as determined by the investigator.
- people with INR out of normal range for the evaluating laboratory for a subject not on anti-coagulant therapy; or INR \>3 for a subject on anti-coagulant therapy.
- people with active/acute or a history of unstable chronic liver disease or current liver disease including but not limited to liver transplant, known genetic disorders such as Gilbert syndrome or other liver diseases.
- people with cirrhosis (e.g., known history or new clinical diagnosis by elastography with a fibrosis score of F3 or F4 and/or steatosis grade of S3).
- people with uncontrolled alcohol use disorder or current alcohol use putting them at risk of liver disease: including consumption of above one standard drink per day for women and two standard drinks per day for men.
- people with known right-sided heart failure or pathologically dilated inferior vena cava or hepatic veins indicative of congestive hepatopathy.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Delray Beach, Florida, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Scarborough, Maine, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Royal Oak, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Lebanon, New Hampshire, United States
- Rochester, New York, United States
- Stony Brook, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Tulsa, Oklahoma, United States
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Delray Beach, Florida, United States; Augusta, Georgia, United States; Chicago, Illinois, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.