Investigation of Stent-grafts in Aortic Dissection (INSTEAD)

A Randomized Comparison of Strategies for Type B Aortic Dissection - the INvestigation of STEnt-grafts in Aortic Dissection (INSTEAD) Trial

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01415804

Acronym

INSTEAD

Enrollment

140

Registered

2011-08-12

Start date

2002-02-28

Completion date

2011-03-31

Last updated

2011-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection

Keywords

Dissection, Aorta, Surgery

Brief summary

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.

Detailed 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.

Interventions

DEVICEendoprosthesis

Thoracic aortic stentgraft

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
All cause mortality	5 years post randomization

Secondary

Measure	Time frame
Aorta-specific mortality	5 years post randomization
Progression of disease	5 years
Aortic remodeling	5 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026