Investigation of Stent-grafts in Aortic Dissection (INSTEAD) (INSTEAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Dissection
• Intervention / Treatment: Device: endoprosthesis

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • MV
    • Rostock, MV, Germany, 18057
      • University Hospital Rostock; Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: stentgraft; Stentgraft	Device: endoprosthesis; Thoracic aortic stentgraft; Other Names: Talent endoprosthesis
No Intervention: Medical management; Antihypertensive medication	Device: endoprosthesis; Thoracic aortic stentgraft; Other Names: Talent endoprosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	5 years post randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Rostock
• Investigators: Principal Investigator: Christoph A Nienaber, MD, University of Rostock

Publications and helpful links

General Publications

• Nienaber CA, Zannetti S, Barbieri B, Kische S, Schareck W, Rehders TC; INSTEAD study collaborators. INvestigation of STEnt grafts in patients with type B Aortic Dissection: design of the INSTEAD trial--a prospective, multicenter, European randomized trial. Am Heart J. 2005 Apr;149(4):592-9. doi: 10.1016/j.ahj.2004.05.060.
• Nienaber CA, Rousseau H, Eggebrecht H, Kische S, Fattori R, Rehders TC, Kundt G, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Ince H; INSTEAD Trial. Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation. 2009 Dec 22;120(25):2519-28. doi: 10.1161/CIRCULATIONAHA.109.886408. Epub 2009 Dec 7.
• Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.

Study record dates

Study Major Dates

• Study Start: February 1, 2002
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (Estimate): August 12, 2011

Study Record Updates

• Last Update Posted (Estimate): August 12, 2011
• Last Update Submitted That Met QC Criteria: August 11, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Surgery; Aorta; Dissection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: NCT00525356; INSTEAD 5 years outcomes (Other Grant/Funding Number: University Hospital Rostock)