A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysm
- Sponsor
- Nectero Medical, Inc.
- Enrollment
- 46
- Locations
- 5
- Primary Endpoint
- Efficacy: Successful delivery of the EAST System into the AAA sac
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
This is a Phase I multi-center, open-label study to evaluate use of the Nectero EAST system for stabilization of abdominal aortic aneurysms. Up to fifty (50) subjects will be treated at up to 10 worldwide sites with the device and followed for up to 36-months. Primary Study Endpoints: * Safety: absence of major events within the 1-month follow-up visit * Success: defined as successful insertion of the delivery catheter and delivery of the Stabilizer Secondary Study Endpoints: * 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. * 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. * Assessment of Clinical Utility Study duration is anticipated to be 6 years.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Efficacy: Successful delivery of the EAST System into the AAA sac
Time Frame: Up to 30 days
Successful insertion of the delivery catheter and delivery of the Stabilizer Compound
Safety: Procedure and Device-Related Adverse Events
Time Frame: Up to 30 days
Absence of major events (procedure and device-related) within the 1-month follow-up visit
Secondary Outcomes
- Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period.(Through study completion, an average of 3 years)
- Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period.(Through study completion, an average of 3 years)