Trial · NCT07911163
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Endpoint | 1 year | The primary endpoint is a composite endpoint defined as the absence of the following events through 12-months post-procedure: * All-cause mortality * Aortic rupture in the treated segment * Unanticipated device-related secondary intervention (endovascular or open surgical) |
| Secondary | Individual Components of Primary Endpoint: All-cause mortality | The secondary endpoints will be measured at each standard of care follow-up timepoint from discharge/30 days through to completion of follow up (approx. 10 years). | Rate of all-cause mortality |
| Secondary | Individual Components of Primary Endpoint: Aortic rupture in the treated segment | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of aortic rupture in the treated segment |
| Secondary | Individual Components of Primary Endpoint: Unanticipated device-related secondary intervention (endovascular or open surgical) | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of unanticipated device-related secondary intervention (endovascular or open surgical) |
| Secondary | Major Adverse Events: Stroke | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of Stroke of any type, including transient ischemia attack (TIA) |
| Secondary | Major Adverse Events: Myocardial Infarction (MI) | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of Myocardial Infarction (MI) |
| Secondary | Major Adverse Events: Paraplegia/Paraparesis | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of Paraplegia/Paraparesis |
| Secondary | Major Adverse Events: Respiratory Failure | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of Respiratory Failure |
| Secondary | Major Adverse Events: Renal Failure | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of Renal Failure |
| Secondary | Major Adverse Events: Bowel Ischemia | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of Bowel Ischemia |
| Secondary | Dissection Endpoints: Entry Flow Type | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Entry Flow (Type I, Type II and Type R) |
| Secondary | Dissection Endpoints: Remodelling | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Positive aortic remodelling in the treated segment(s), defined as either: * false lumen reduction in maximal diameter or volume and no growth in total aortic diameter or volume * true lumen expansion in maximal diameter or volume and no growth in total aortic diameter or volume; or * total aortic maximal diameter reduction with variable changes in true and false lumen diameters. |
| Secondary | Clinical Utility Measures | Perioperative | Procedure time (hours) |
| Secondary | Clinical Utility Measures | Discharge/30 days | Time in the Intensive Care Unit (ICU) (days) |
| Secondary | Clinical Utility Measures | Discharge/30 days | Time in Hospital (days) |
| Secondary | Technical Success | Day 1 | Technical Success is a composite endpoint evaluated at the index procedure by the implanting physician and is defined as follows: * Successful access to the arterial system * Successful delivery and accurate placement of the implant in the planned location without unplanned vessel coverage * Absence of device deformations requiring unplanned placement of an additional device (at the index procedure) * Patency of the implant (including branches) without significant twist, kinks or obstruction * Successful retrieval of the device delivery system (without unanticipated corrective action related to the withdrawal) * No need for unanticipated corrective intervention or emergency surgery to achieve the above goals Technical success can include the use of additional modular components, stents, or angioplasty and adjunctive surgical procedures at the time of the primary procedure. |
| Secondary | Lesion- and/or device-related secondary intervention | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of lesion- and/or device-related secondary intervention |
| Secondary | Lesion related mortality | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of Lesion-related mortality |
| Secondary | Intraluminal Thrombosis (ILT) | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of Intraluminal Thrombosis (ILT) |
| Secondary | Device occlusion | The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years). | Rate of Device occlusion |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07911163/registered