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

NCT00525356 | Completed Phase 3 DMC

• 1 other identifier: INSTEAD trial
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Diseases

Keywords

Aorta; Dissection; Thoracic

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  1 year

Secondary Outcomes (1)

• thrombosis of the false lumen, cardiovascular morbidity, degree of aortic expansion, length of intensive care and hospital stay, and quantitative assessment of single or combination antihypertensive drug therapy.

  5 years

Study Arms (1)

1

ACTIVE COMPARATOR

Anti-hypertensive medical treatment

Device: Medtronic Talent Stent-Graft-System

Interventions

Medtronic Talent Stent-Graft-System DEVICE

Also known as: Endograft

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Medtronic Bakken Research Center

Maastricht, 6229 GW, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 15990739 BACKGROUND

• 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.

  PMID: 19996018 BACKGROUND

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• C A Nienaber, MD, FESC, FACC

  Division of Cardiology and Internal Medicine Department, Rostock University, Germany.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: February 1, 2002
• Study Completion: September 1, 2007
• Last Updated: October 29, 2015

Record last verified: 2007-09

Locations

NL (1)