AneuFix - Prophylactic Sac Filling

Launched by TRIPLEMED B.V. · Mar 11, 2020

Keywords

ClinConnect Summary

The AneuFix trial is studying a new procedure to help prevent complications in patients undergoing a specific type of surgery for an abdominal aortic aneurysm (AAA). This condition involves an enlargement of the aorta, the main blood vessel in the body, which can be dangerous if it bursts. The study focuses on using AneuFix during the surgery to fill a sac that could lead to a problem called endoleak, which occurs when blood leaks back into the aneurysm after the surgery. The trial is currently recruiting patients aged 65 to 74 who have an AAA that needs surgical treatment and have certain risk factors for developing endoleaks.

To be eligible for this trial, patients must be asymptomatic (not showing symptoms) and have specific anatomical conditions that make them suitable for the procedure. Participants should expect to follow the study's requirements and will be monitored closely during and after the surgery. This trial is important because it aims to improve the safety and effectiveness of AAA surgeries, potentially reducing the risk of complications for patients. If you're considering participating, it’s essential to discuss it with your doctor to see if you meet the criteria and if it’s the right option for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:
• • - Open IMA AND
• • 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) \>17,5cm2 OR
• • 2 patent lumbars AND a CSAIMA \>15cm2 OR
• • 3 patent lumbars AND a CSAIMA \>12,5 cm2 OR
• • 4 patent lumbars AND a CSAIMA \>10 cm2 OR
• • 5 patent lumbars AND a CSAIMA \>7,5 cm2
• • Infrarenal neck according to the IFU of the EVAR device
• • Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used
• • Patient having a life expectation of at least 2 years
• • Being older than 18 years
• • Willing and able to comply with the requirements of this clinical study
• Exclusion Criteria:
• • Patient not able or willing to give written Informed Consent
• • Patient undergoing emergency procedures
• • Patient undergoing EVAR for ruptured or symptomatic AAA,
• • Patient with a suprarenal AAA
• • Patient with an inflammatory AAA (more than minimal wall thickening)
• • Patient with an infrarenal neck unsuitable for endovascular fixation (including so called "hostile necks") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
• • Patient in which a bilateral retroperitoneal incision is required for EVAR
• • Patient in which a sacrifice of both hypogastric arteries is required
• • Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
• • Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent
• • Patient with active infection present
• • Patients scheduled for or having received an organ transplant
• • Patient with limited life expectation due to other illness (\<1 year)
• • Patient with non-iatrogenic bleeding diathesis
• • Patient with connective tissue disease
• • Women of child-bearing potential
• • Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation