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Investigation of Stent-grafts in Aortic Dissection (INSTEAD)

This study has been completed.
Sponsor:
Information provided by:
University of Rostock
ClinicalTrials.gov Identifier:
NCT01415804
First received: August 11, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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 Intervention Phase
Aortic Dissection
 Device: endoprosthesis
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 5 years post randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Aorta-specific mortality [ Time Frame: 5 years post randomization ] [ Designated as safety issue: Yes ]
  • Progression of disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Aortic remodeling [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: February 2002
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

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: NCT00525356, INSTEAD 5 years outcomes
Study First Received: August 11, 2011
Last Updated: August 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by University of Rostock:
Dissection
Aorta
Surgery

ClinicalTrials.gov processed this record on May 21, 2013