Investigation of Stent-grafts in Aortic Dissection (INSTEAD)

University of Rostock140 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Aortic Dissection

Interventions

endoprosthesisDEVICE

Thoracic aortic stentgraft

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Rostock; Heart Center

Rostock, Mecklenburg-Vorpommern, Germany

Outcomes

Primary Outcomes

All cause mortality

Time frame: 5 years post randomization

Secondary Outcomes

Aorta-specific mortality

Time frame: 5 years post randomization

Progression of disease

Time frame: 5 years

Aortic remodeling

Time frame: 5 years

Data from ClinicalTrials.gov

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