The Single Branch NEXUS™ Clinical Study (NexusSB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03208504|
Recruitment Status : Active, not recruiting
First Posted : July 5, 2017
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Aortic Diseases||Device: Nexus™ Aortic Arch Stent graft||Not Applicable|
The purpose of the study is to evaluate the safety and performance of the Single Branch Nexus™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone2). The investigational device is the Single Branch Nexus™ Aortic Arch Stent Graft System and its designated Delivery System.
Subject population: ten (10) subjects diagnosed with thoracic aortic disease involving the aortic arch, and who have appropriate anatomy to accommodate the Single Branch Nexus™ delivery system in an endovascular procedure. The study will be conducted in 2 clinical sites in Germany.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, open-label, non-randomized, interventional clinical study. All subjects will be treated by implantation of the Single Branch Nexus™ Aortic Arch Stent graft System.|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center Prospective Open-Label Non-Randomized Clinical Study to Evaluate the Safety and Performance of the Single Branch Nexus™ Aortic Arch Stent Graft System.|
|Actual Study Start Date :||November 27, 2017|
|Actual Primary Completion Date :||February 16, 2018|
|Estimated Study Completion Date :||January 2023|
All subjects in treatment arm will be implanted with the Single Branch Nexus™ Aortic Arch Stent graft System.
Device: Nexus™ Aortic Arch Stent graft
surgical implantation of Nexus™ Aortic Arch Stent graft
- Primary Safety Endpoint - proportion of patients free from MAEs within 30 days [ Time Frame: 30 days post implantation ]Proportion of subjects free from MAEs within 30 days post implantation. MAE is defined as: all-cause mortality, myocardial infarction, renal failure, paraplegia, stroke and bowel ischemia for which a causal relationship with the device cannot be excluded on the basis of the adjudication of the independent Data Monitoring Committee (DMC).
- Primary Performance Endpoint -Assessment of the rate of successful disease treatment at 30 days [ Time Frame: 30 days post implantation ]Assessment of the rate of successful disease treatment at 30 days post implantation, defined as: Successful delivery and deployment of the device, meaning device was deployed and located in the aortic arch isolating the diseased lesion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208504
|Düsseldorf, Nordrhein-Westfalen, Germany, 40225|
|Askelpios Klinikum Hamburg|
|Hamburg, Germany, 21075|
|Study Director:||Orly Schwartz||Endospan Ltd.|