Trial · NCT07885865
A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement
NCT07885865, Not applicable, Not yet recruiting, University of Maryland, Baltimore
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement. Trials, record NCT07885865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07885865
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement
- NCT number
- NCT07885865
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 100 participants, estimated
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Aortic Aneurysm, Aortic Dissection, Penetrating Aortic Ulcer (PAU), Aortic Pseudoaneurysm, Aortic Arch Replacement
- Interventions
- Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause mortality | 30 days | Rate of death from any cause |
| Primary | Stroke, excluding transient ischemic attack (TIA) | 30 days | Rate of stroke |
| Primary | Early Paralysis, excluding paraparesis | 30 days | Rate of paralysis |
| Primary | Technical success | 24 hours | Composite of successful delivery of the device through the vasculature, successful deployment of the device at the intended location, and patient survival |
| Primary | Patency of all graft and endograft components | At hospital discharge or at 1 month | Graft and endograft patency confirmed by computed tomography (CT) imaging assessment |
| Primary | Complete sealing of the aortic pathology | At hospital discharge or at 1 month | Absence of Type Ia and IIIa/b endoleak, complete coverage of penetrating aortic ulcer (PAU) cases, and isolation of the primary entry tear in dissection cases, confirmed by CT imaging assessment |
| Secondary | Aortic-related death | Up to 36 months after the index procedure | Rate of aortic-related death |
| Secondary | Pseudoaneurysm at the treatment sites | Up to 36 months after the index procedure | Rate of pseudoaneurysm at the treatment sites |
| Secondary | Unanticipated aortic or branch-related reoperation | Up to 36 months after the index procedure | Rate of unanticipated aortic or branch-related reoperation |
| Secondary | Late endoleak | Up to 36 months after the index procedure | Rate of Type I or III endoleak confirmed by computed tomography (CT) imaging assessment |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07885865
GET https://conductscience.org/api/trials/v1/NCT07885865/registered?page=2