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

October 28, 2015 updated by: Medtronic Bakken Research Center

INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Maastricht, Netherlands, 6229 GW
        • Medtronic Bakken Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Anti-hypertensive medical treatment
Other Names:
  • Endograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: C A Nienaber, MD, FESC, FACC, Division of Cardiology and Internal Medicine Department, Rostock University, Germany.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 4, 2007

First Posted (ESTIMATE)

September 5, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

September 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • INSTEAD trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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