Investigation of Stent-grafts in Aortic Dissection (INSTEAD)

University of Rostock

Status and phase: Completed; Phase 3; Phase 2

Conditions: Aortic Dissection

Treatments: Device: endoprosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT01415804

NCT00525356

INSTEAD 5 years outcomes (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

stentgraft

Active Comparator group

Description:

Stentgraft

Treatment:

Device: endoprosthesis

Medical management

No Intervention group

Description:

Antihypertensive medication

Treatment:

Device: endoprosthesis