Status:
COMPLETED
Investigation of Stent-grafts in Aortic Dissection (INSTEAD)
Lead Sponsor:
University of Rostock
Conditions:
Aortic Dissection
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of INSTEAD is to compare long-term (5 years) outcomes of endograft prosthesis versus medical management in patients with dissection of the thoracic aorta.
Detailed Description
Patients \> 18 years with type B aortic dissection were randomized to either thoracic aortic endoprosthesis (stent-grafting) or antihypertensive management (medical treatment). Only stable patients wi...
Eligibility Criteria
Inclusion
- No contraindication the general anesthesia and ventilation
- Type B aortic dissection that occurred 2-52 weeks prior to randomization
- Diameter of the targeted aortic segment \< 6 cm
- Subject or legal guardian understand the nature of teh study and agrees to its provisions on a written informed consent form
- Availability for appropriate follow-up visits during the F/U period of 5 years
- Capability to follow all study requirements
Exclusion
- Pregnancy
- Thrombocytopenia
- Ongoing anticoagulation therapy
- Renal failure and/or creatinine \> 2,4 mg%
- Complete thrombosis of false lumen
- Cancer likely to cause death within 1 year
- Enrollment in another clinical study
- Unwillingness to cooperate with study procedures or F/U visits
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01415804
Start Date
February 1 2002
End Date
March 1 2011
Last Update
August 12 2011
Active Locations (1)
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1
University Hospital Rostock; Heart Center
Rostock, Mecklenburg-Vorpommern, Germany, 18057