NCT01415804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
Last Updated

August 12, 2011

Status Verified

March 1, 2011

Enrollment Period

8.7 years

First QC Date

August 11, 2011

Last Update Submit

August 11, 2011

Conditions

Aortic Dissection

Keywords

DissectionAortaSurgery

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    5 years post randomization

Secondary Outcomes (3)

  • Aorta-specific mortality

    5 years post randomization

  • Progression of disease

    5 years

  • Aortic remodeling

    5 years

Study Arms (2)

stentgraft

ACTIVE COMPARATOR

Stentgraft

Device: endoprosthesis

Medical management

NO INTERVENTION

Antihypertensive medication

Device: endoprosthesis

Interventions

endoprosthesisDEVICE

Thoracic aortic stentgraft

Also known as: Talent endoprosthesis
Medical managementstentgraft

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Rostock; Heart Center

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Related Publications (3)

  • 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: 15990739BACKGROUND

  • 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: 19996018RESULT

  • 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.

    PMID: 23922146DERIVED

MeSH Terms

Conditions

Aortic Dissection

Interventions

Prostheses and Implants

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Christoph A Nienaber, MD

    University of Rostock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 12, 2011

Study Start

February 1, 2002

Primary Completion

October 1, 2010

Study Completion

March 1, 2011

Last Updated

August 12, 2011

Record last verified: 2011-03

Locations

DE(1)