RecruitingPhase 2ACTRN12609000706279

The Nellix Endograft System for Abdominal Aortic Aneurysm Treatment

Feasibility and safety study of the Nellix Endograft System for Exclusion of infrarenal aortic or aorto-iliac abdominal aortic aneurysms


Sponsor

Nellix Endovascular Inc.

Enrollment

20 participants

Start Date

Nov 24, 2008

Study Type

Interventional

Conditions

Summary

This study will determine the feasibility and safety of the Nellix Endograft System for use in patients with infrarenal abdominal aortic aneurysms.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new medical device called the Nellix Endograft System for treating a condition called abdominal aortic aneurysm (AAA) — a bulge in the main artery of the abdomen that can be life-threatening if it bursts. The Nellix system is inserted through the groin using a minimally invasive approach (no large abdominal cut needed) and uses special polymer-filled sacs to seal off the aneurysm. This trial is looking at whether the procedure is safe and feasible, and will follow patients with regular check-ups. You may be eligible if: - You are 18 years of age or older - You have an abdominal aortic aneurysm larger than 4 cm in diameter - The neck of your aorta (just below the kidneys) is between 18 and 26 mm wide - You are otherwise a candidate for open surgical repair of the aneurysm - You are able to attend follow-up visits You may NOT be eligible if: - You have acute kidney failure - Your aneurysm has recently ruptured or is leaking - You have other serious medical conditions that increase surgical risk - You are pregnant Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The Nellix AAA System is a catheter based system used to treat aneurysms between the renal and iliac arteries by excluding the aneurysm sac thereby preventing rupture. The System includes two Nellix

The Nellix AAA System is a catheter based system used to treat aneurysms between the renal and iliac arteries by excluding the aneurysm sac thereby preventing rupture. The System includes two Nellix Cathters placed into the vascular space via the femoral arteries. The Nellix Implant is positioned below the renal arteries and will terminate in each of the common iliac arteries. After positioning the Nellix catheters across the aneurysm, the Deployment Balloons are simultaneously inflated to deploy the Endoframe, and then deflated. The in-situ curing Polymer material is injected into the Endobag, thereby expanding the bag to fill the aneurysmal space between the Endoframe and the sac wall and excluding the aneurysm which forms the Implant. The Endoframe/Endobag is then released from the Nellix Catheter and the Catheters are removed from the patient. The average Nellix procedure time is approximately 45 to 60 minutes.


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ACTRN12609000706279