INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- all-cause mortality
Study Overview
Brief Summary
The objective of this study is to compare treatment with an endograft prothesis versus antihypertensive treatment in patients with a dissection of the thoracic aorta.
Detailed Description
Patients older than 18 years with type B aortic dissection as diagnosed by computed tomography or magnetic resonance angiography are randomized to either a thoracic aortic endoprosthesis and antihypertensive treatment, called "stent grafting," or a tailored antihypertensive treatment, called "medical treatment."
Only patients in a clinically stable condition and without spontaneous thrombosis of the false lumen after 14 days of the index dissection are considered eligible for study inclusion.
Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study design calls for 136 patients to be randomized and monitored for 24 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •No contraindication for an anesthetic procedure with intubation
- •Type B aortic dissection that occurred 2-52 weeks before randomization
- •Diameter of the targeted aortic segment ≤6 cm
- •Aortic kinking <75°
- •The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
- •Availability for the appropriate follow-up visits during the follow-up period
- •Capability to follow all study requirements
Exclusion Criteria
- •Pregnant woman
- •Thrombocytopenia or ongoing anticoagulation therapy
- •Renal failure and/or creatinine >2.4 mg%
- •Complete thrombosis of the false lumen
- •Ongoing infection
- •Cancer is likely to cause death within 1 year
- •Enrolment in another clinical study
- •Unwillingness to cooperate with study procedures or follow-up visits
Outcomes
Primary Outcomes
all-cause mortality
Time Frame: 1 year
Secondary Outcomes
- thrombosis of the false lumen, cardiovascular morbidity, degree of aortic expansion, length of intensive care and hospital stay, and quantitative assessment of single or combination antihypertensive drug therapy.(5 years)