Safety and Effectiveness Assessment of AneuFix Injectable Polymer Sac Filling to Assure Long-term Durability of EVAR.
NCT07928505, Not applicable, Not yet recruiting, TripleMed B.V.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Safety and Effectiveness Assessment of AneuFix Injectable Polymer Sac Filling to Assure Long-term Durability of EVAR. | ClinicalTrials.gov |
| NCT number | NCT07928505 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | TripleMed B.V. | ClinicalTrials.gov |
| Conditions | Endoleak After Endovascular Aneurysm Repair, Aortic Aneurysm Abdominal | ClinicalTrials.gov |
| Interventions | AneuFix Injectable Polymer, Endovascular AneuRysm Repair (EVAR) | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Composite Treatment Success at 12 Months | 12 Months | Proportion of subjects achieving treatment success at 12 months, defined as single composite of: * Freedom from incidence of Type II endoleak; * Freedom from Sac Growth (\>5 mm); * Freedom from AAA-related secondary intervention. | ClinicalTrials.gov |
| Primary | Major Adverse Event (MAE) rate within the 30-day follow-up period after the procedure | 30 Days Post-Procedure | Major Adverse Event (MAE) rate within the 30-day follow-up period after the procedure. * MAE related to the AneuFix Injectable Polymer Sac Filling procedure: ischemia in end organs (bowel, spine, legs) or paraplegia due to non-target embolization, perforation, rupture * MAE related to the EVAR procedure: all-cause mortality, AAA-related mortality, myocardial infarction, renal failure, respiratory failure, stroke or procedural blood loss \>1000 ml. * Conversion to Open Repair | ClinicalTrials.gov |
| Secondary | Incidence of Type II Endoleak (T2EL) | 1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure | Percentage of subjects with a persistent or recurrent Type II endoleak confirmed by imaging assessment. | ClinicalTrials.gov |
| Secondary | Incidence of Type I, III or IV Endoleak | 1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure | Percentage of subjects with a Type I, III or IV endoleak identified on imaging assessment. | ClinicalTrials.gov |
| Secondary | Change in Aneurysm Sac Diameter | 2 years, 3 years, 4 years, and 5 years Post-Procedure | Change in maximum aneurysm sac diameter measured in millimeters (mm) compared with baseline. | ClinicalTrials.gov |
| Secondary | Change in Aneurysm Sac Volume | 2 years, 3 years, 4 years, and 5 years Post-Procedure | Change in aneurysm sac volume measured in cubic centimeters (cm³) compared with baseline. | ClinicalTrials.gov |
| Secondary | Aneurysm-Related Reintervention Rate | Until the end of study (5 years) | Percentage of subjects requiring aneurysm-related reintervention. Reinterventions will be categorized as open surgical or endovascular procedures and the reason will be recorded. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)