Abdominal Aortic Aneurysm Clinical Trial
— AAAOfficial title:
A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
Verified date | January 2024 |
Source | Nectero Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a first in human study to evaluate the safety and clinical utility of an investigational medical device called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
Status | Active, not recruiting |
Enrollment | 46 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or Female aged 18 years or older - Subject can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent and is willing to complete the follow-up according to the requirements of the protocol. - Infrarenal non-aneurysmal neck =15mm in length - Aortic neck diameters = 29mm - Infrarenal neck angulation = 60° - Abdominal aneurysm from 3.5 cm to 5.0 cm. - Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 10 cm - Patient iliac or femoral arteries access vessels' size and morphology allow endovascular access of 14F introducer sheaths and catheters. - Subject has > one-year life expectancy. - Subject is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive. - Subject is able and willing to comply with 1, 3, 6, 12, 24 and 36-month follow-up. Exclusion Criteria: - Subject has an acutely ruptured or leaking or emergent aneurysm. - Subject has a dissecting aneurysm. - Subject has a mycotic or infected aneurysm. - Subject has current vascular injury due to trauma. - Subject's aneurysm is thoracic or suprarenal. - Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm. - Subject has thrombus, calcification, and/or plaque that may compromise delivery. - Subject has had a myocardial infarction within six (6) months prior to enrollment. - Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease. - Subject has undergone other major surgery within the 30 days prior to enrollment. - Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months. - Known allergy to polyester or contrast material that cannot be pretreated. - Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta. - Subject has connective tissue disease (e.g., Marfan syndrome, Eaton syndrome, or Bessel's disease). - Known contraindication to undergoing angiography or anticoagulation. - Subject has active systemic infection. - Subject is participating in another research study. - Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment. - Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the trial. - Subject has dialysis dependent renal failure or baseline serum creatinine level >2.0mg/dl. - Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) is five times higher than the normal upper limit; serum total bilirubin (STB) is two times higher than the normal upper limit. - Subjects who are not suitable for endovascular treatment, as judged by the investigator. |
Country | Name | City | State |
---|---|---|---|
Australia | Prince of Wales Private Hospital | Randwick | New South Wales |
China | Queen Mary Hospital | Hong Kong | Southern District |
Colombia | Pablo Tabon Uribe Hospital | Medellín | Antioquia |
New Zealand | Auckland City Hospital | Auckland |
Lead Sponsor | Collaborator |
---|---|
Nectero Medical, Inc. |
Australia, China, Colombia, New Zealand,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: Procedure and Device-Related Adverse Events | Absence of major events (procedure and device-related) within the 1-month follow-up visit | Up to 30 days | |
Primary | Efficacy: Successful delivery of the EAST System into the AAA sac | Successful insertion of the delivery catheter and delivery of the Stabilizer Compound | Up to 30 days | |
Secondary | Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period. | Freedom from aneurysmal sac enlargement. Enlargement is defined as diameter increase of >5mm per year, or aneurysm sac volume increase of >10% per year, as assessed by CT scans at the 1, 3, (HK only), 6, 12, 24 and 36-month follow-up visits. | Through study completion, an average of 3 years | |
Secondary | Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period. | Aneurysm sac shrinkage, defined as diameter decrease of >5mm, or decrease in aneurysm sac volume of >10% as assessed by CT scans at the 1, 3 (HK only), 6, 12, 24 and 36-month follow-up visits. | Through study completion, an average of 3 years |
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