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Investigation of Stent-grafts in Aortic Dissection (INSTEAD) (INSTEAD)

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ClinicalTrials.gov Identifier: NCT01415804
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : August 12, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Aortic Dissection Device: endoprosthesis Phase 2 Phase 3

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 without spontaneous false lumen thrombosis 14 days after index dissection were considered eligible for study inclusion. Long-term outcome measures included all-cause mortality, aorta-specific mortality and a cluster endpoint (reflecting progression of disease, conversion and additional interventions); the analysis is based on 140 randomized cases followed for at least 5 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Strategies for Type B Aortic Dissection - the INvestigation of STEnt-grafts in Aortic Dissection (INSTEAD) Trial
Study Start Date : February 2002
Primary Completion Date : October 2010
Study Completion Date : March 2011
Arms and Interventions

Arm Intervention/treatment
Active Comparator: stentgraft
Stentgraft
Device: endoprosthesis
Thoracic aortic stentgraft
Other Name: Talent endoprosthesis
No Intervention: Medical management
Antihypertensive medication
Device: endoprosthesis
Thoracic aortic stentgraft
Other Name: Talent endoprosthesis


Outcome Measures

Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 5 years post randomization ]

Secondary Outcome Measures :
  1. Aorta-specific mortality [ Time Frame: 5 years post randomization ]
  2. Progression of disease [ Time Frame: 5 years ]
  3. Aortic remodeling [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01415804


Locations
Germany
University Hospital Rostock; Heart Center
Rostock, MV, Germany, 18057
Sponsors and Collaborators
University of Rostock
Investigators
Principal Investigator: Christoph A Nienaber, MD University of Rostock
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph A.Nienaber, MD, University of Rostock, Medical School; Dept. of Medicine/Cardiology
ClinicalTrials.gov Identifier: NCT01415804     History of Changes
Other Study ID Numbers: INSTEAD 5 years outcomes ( Other Grant/Funding Number: University Hospital Rostock )
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: March 2011

Keywords provided by University of Rostock:
Dissection
Aorta
Surgery