Prophylactic filling of abdominal aortic aneurysm sacs
Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation
NA · TripleMed B.V. · NCT04307992
This study is testing if a new device can safely fill the sacs of abdominal aortic aneurysms during surgery to help prevent leaks in high-risk patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TripleMed B.V. (industry) |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT04307992 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility and safety of using the AneuFix device to fill the sac of asymptomatic abdominal aortic aneurysms (AAA) during endovascular aneurysm repair (EVAR) procedures. The AneuFix polymer is designed to block backflowing blood vessels, thereby preventing endoleaks by filling the voids and feeding arteries associated with the aneurysm. The study aims to determine how effectively this intervention can mitigate the risk of developing type II endoleaks in high-risk patients.
Who should consider this trial
Good fit: Ideal candidates are asymptomatic patients with infrarenal AAA who have a high risk of developing type II endoleaks and meet specific anatomical criteria.
Not a fit: Patients undergoing emergency procedures or those with ruptured or symptomatic AAA will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of endoleaks in patients undergoing EVAR for AAA.
How similar studies have performed: While the use of similar prophylactic techniques has been explored, the specific application of AneuFix in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam, North Holland
- VUmc — Amsterdam, North Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Arjan WJ Hoksbergen, Dr — VUmc Heelkunde, Amsterdam
- Study coordinator: Florie Daniels
- Email: f.daniels@triple-med.com
- Phone: +31 6 38 19 92 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Abdominal Aortic Aneurysm, Endoleak