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INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

This study has been completed.
Sponsor:
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00525356
First received: September 4, 2007
Last updated: November 14, 2011
Last verified: September 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Aortic Diseases
 Device: Medtronic Talent Stent-Graft-System
 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: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • all-cause mortality [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 5 years ]

Enrollment: 136
Study Start Date: February 2002
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: 1
Anti-hypertensive medical treatment
 Device: Medtronic Talent Stent-Graft-System
Other Name: Endograft

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525356

Locations
Netherlands
Medtronic Bakken Research Center
Maastricht, Netherlands, 6229 GW
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: C A Nienaber, MD, FESC, FACC Division of Cardiology and Internal Medicine Department, Rostock University, Germany.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00525356     History of Changes
Other Study ID Numbers: INSTEAD trial
Study First Received: September 4, 2007
Last Updated: November 14, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Germany: Ethics Commission
Italy: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Austria: Ethikkommission

Keywords provided by Medtronic Bakken Research Center:
Aorta
Dissection
Thoracic

Additional relevant MeSH terms:
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013