Hybrid Treatment of Type B Aortic Dissection
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|ClinicalTrials.gov Identifier: NCT02726841|
Recruitment Status : Unknown
Verified September 2017 by Dmitry Sirota, Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was: Enrolling by invitation
First Posted : April 4, 2016
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aortic Dissection Type B||Procedure: Open thoracoabdominal aortic repair + abdominal stenting Procedure: Classic thoracoabdominal aortic repair||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Superiority Trial of Type b Aortic Dissection Treatment Combined With Implantation of Bare Metal Stent in Abdominal Part of Aorta Versus Conventional Type b Treatment|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Hybrid TAAD repair
The group includes patients who underwent open thoracoabdominal aortic repair + abdominal stenting.
Procedure: Open thoracoabdominal aortic repair + abdominal stenting
Thoracoabdominal aortic dissection (TAAD) repair + bare aortic stent (Djumbodis) implantation
Other Name: Hybrid thoracoabdominal aortic repair
Active Comparator: Conventional TAAD repair
The group includes patients who underwent classic thoracoabdominal aortic repair with dacron prosthesis.
Procedure: Classic thoracoabdominal aortic repair
Thoracoabdominal aortic dissection (TAAD) repair
Other Name: Conventional TAAD repair
- Permanent neurological events [ Time Frame: 30 days ]Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.
- Perioperative bleeding [ Time Frame: 5 days after procedure ]Volume of perioperative and postoperative bleeding in ICU
- Mortality [ Time Frame: 6 months ]Postoperative mortality will be measured during 6 months after procedure
- Visceral malperfusion [ Time Frame: 6 months ]Clinical evidences of visceral malperfusion (acute or achronic abdomen ischemia) during 6 months after procedure (Yes or No)
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): NCT02726841
|Study Chair:||Alexander M. Chernyavskiy, MD PhD||Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation|