Aortic DiseasesPhase 3INSTEADNCT00525356
INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
A Phase 3 study testing Medtronic Talent Stent-Graft-System in people with Aortic Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Diseases
- What is being tested?
- Medtronic Talent Stent-Graft-System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2002to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
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.
Read the detailed description
Patients older than 18 years with type B aortic dissection as diagnosed by computed tomography or magnetic resonance angiography are randomized to either a thoracic aortic endoprosthesis and antihypertensive treatment, called "stent grafting," or a tailored antihypertensive treatment, called "medical treatment."
Only patients in a clinically stable condition and without spontaneous thrombosis of the false lumen after 14 days of the index dissection are considered eligible for study inclusion.
Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study design calls for 136 patients to be randomized and monitored for 24 months.
- Conditions
- Aortic Diseases
- Being tested
- Medtronic Talent Stent-Graft-System
- Keywords
- Aorta, Dissection, Thoracic
- Medical subject headings
- Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Talent Stent-Graft-SystemDevice
Also called Endograft
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Anti-hypertensive medical treatment Receives: Device: Medtronic Talent Stent-Graft-System |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startFeb 2002
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- C A Nienaber, MD, FESC, FACC, Principal investigator, Division of Cardiology and Internal Medicine Department, Rostock University, Germany.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525356
- Sponsor's protocol ID
- INSTEAD trial
- Acronym
- INSTEAD
- Status last verified
- Sep 2007
- First submitted
- 4 Sep 2007
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15990739Nienaber 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.
PubMed 19996018
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT00525356
- Acronym / sponsor ID
- INSTEAD / INSTEAD trial
- Conditions
- Aortic Diseases
- Keywords
- Aorta, Dissection, Thoracic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Study completion
- Sep 2007 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients older than 18 years with type B aortic dissection as diagnosed by computed tomography or magnetic resonance angiography are randomized to either a thoracic aortic endoprosthesis and antihypertensive treatment, called "stent grafting," or a tailored antihypertensive treatment, called "medical treatment."
Only patients in a clinically stable condition and without spontaneous thrombosis of the false lumen after 14 days of the index dissection are considered eligible for study inclusion.
Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study design calls for 136 patients to be randomized and monitored for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Medtronic Talent Stent-Graft-SystemAnti-hypertensive medical treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnant woman
- Thrombocytopenia or ongoing anticoagulation therapy
- Renal failure and/or creatinine >2.4 mg%
- Complete thrombosis of the false lumen
- Ongoing infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Talent Stent-Graft-SystemAlso: Endograft | Device | 1 |
Primary outcome
all-cause mortality
Time frame: 1 year
1 secondary outcome
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.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Background: PubMed 15990739Nienaber 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.
- Background: PubMed 19996018Nienaber 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.
Related trials for Aortic Diseases
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C A Nienaber, MD, FESC, FACC principal investigator
Division of Cardiology and Internal Medicine Department, Rostock University, Germany.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medtronic Talent Stent-Graft-System in people with Aortic Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00525356, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.