Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
Shanghai, Shanghai Municipality, 201801, China
Location status: Recruiting
NCT Number: NCT07405242
This study is a single-arm, open-label, multi-center clinical trial evaluating the safety and efficacy of endovascular treatment for retrograde dissection involving the ascending aorta that is not suitable for open surgery. The aim is to assess the short-term (30 days) and medium- to long-term (6 months and 12 months) safety and efficacy of endovascular treatment in patients with retrograde dissection involving the ascending aorta who are not suitable for open surgery. The study plans to include patients with dissection confirmed by imaging, with the tear located in the aortic arch or descending aorta and extending retrogradely to the ascending aorta, and the most distal segment of the dissection is at least 2 cm away from the coronary artery ostia. These patients have been evaluated by cardiac surgery and found to be unsuitable for open surgery, with significant risks or risks outweighing benefits associated with open surgery. This is a single-arm, open-label, multi-center study, and no blinding or randomization will be used, nor will stratification factors be set. After successful screening, the subjects will undergo endovascular treatment for aortic dissection (stent implantation) during the operation. The subjects will be followed up for one year after the operation, and the safety and efficacy of endovascular treatment for retrograde dissection involving the ascending aorta will be evaluated based on the subjects' survival status, the occurrence of surgery and disease-related complications, and the recovery of the disease.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 201801, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Endovascular treatment of aortic dissection (stent implantation)
Time frame: 30 days
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
A Single-arm, Open-label, Multicenter Clinical Study Evaluating the Safety and Efficacy of Endovascular Treatment for Retrograde Dissections Involving the Ascending Aorta That Are Not Suitable for Open Surgery. (RADIAL)
Acronym: RADIAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05927090
Acute Aortic Syndrome, Aneurysm
Saint-Denis, France
View Trial DetailsNCT00583817
Acute Aortic Syndrome, Aneurysm
Boston, Massachusetts, United States
View Trial DetailsNCT04545502
Acute Aortic Syndrome, Aneurysm
Aurora, Colorado, United States
View Trial DetailsNCT00429364
Abnormalities, Multiple, Acute Aortic Syndrome
Los Angeles, California, United States
View Trial Details