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

Medtronic

Status and phase: Completed; Phase 3

Conditions: Aortic Diseases

Treatments: Device: Medtronic Talent Stent-Graft-System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00525356

INSTEAD trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 1 patient group

1

Active Comparator group

Description:

Anti-hypertensive medical treatment

Treatment:

Device: Medtronic Talent Stent-Graft-System