Dataset Information

Protocol for the ROBUST (Registry Of type B aortic dissection with the Utility of STent graft) study: an ambispective, multicentre, open cohort study.

ABSTRACT:

Introduction

Thoracic endovascular aortic repair (TEVAR) is widely used for type B aortic dissection, although with satisfactory outcome in a limited proportion of patients. To better inform patient prognostication, the Registry Of type B aortic dissection with the Utility of STent graft (ROBUST) study aims to identify imaging-based predictors of post-TEVAR adverse outcomes up to 10-year follow-up.

Methods and analysis

ROBUST is designed as an ambispective, multicentre, open cohort study. All patients undergoing TEVAR from 1 January 2008 to 1 July 2027 at participating centres will be invited to join the study. It is conservatively estimated that over 2000 patients will join the study. Data on demographics, disease history, procedural details, imaging features and follow-up will be collected after discharge. Cox proportional-hazards analysis will be used to identify independent predictors of primary outcomes. Stratification analysis will be performed to identify which subgroup of patients would benefit the most from TEVAR.

Ethics and dissemination

The protocol has been approved by the ethics committee of the coordinating centre. Findings will be disseminated in professional peer-reviewed journals to promote understanding of the rehabilitation process.

Trial registration number

ChiCTR-POC-17011726; Pre-results.

SUBMITTER: Rong D

PROVIDER: S-EPMC5778342 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Protocol for the ROBUST (Registry Of type B aortic dissection with the Utility of STent graft) study: an ambispective, multicentre, open cohort study.

Rong Dan D Ge Yangyang Y Xue Yan Y Liu Feng F Lu Kai K Liu Peng P Zhang Lei L Ge Xiaohu X Miu Jianhang J Zhong Linkun L Fan Weidong W Zhang Hongpeng H Jia Xin X Ma Xiaohui X Xiong Jiang J Liu Xiaoping X Guo Wei W

BMJ open 20171214 12

<h4>Introduction</h4>Thoracic endovascular aortic repair (TEVAR) is widely used for type B aortic dissection, although with satisfactory outcome in a limited proportion of patients. To better inform patient prognostication, the Registry Of type B aortic dissection with the Utility of STent graft (ROBUST) study aims to identify imaging-based predictors of post-TEVAR adverse outcomes up to 10-year follow-up.<h4>Methods and analysis</h4>ROBUST is designed as an ambispective, multicentre, open cohor ...[more]

PMID: 29247114

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Project description:BackgroundSince 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval.ObjectiveThis registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience.MethodsAll consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint.ResultsThe study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups.ConclusionsThe results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label.Trial registrationClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892.International registered report identifier (irrid)PRR1-10.2196/36995.

Dataset Information

Protocol for the ROBUST (Registry Of type B aortic dissection with the Utility of STent graft) study: an ambispective, multicentre, open cohort study.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Protocol for the ROBUST (Registry Of type B aortic dissection with the Utility of STent graft) study: an ambispective, multicentre, open cohort study.

Similar Datasets

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