Aortic DiseasesADSORBNCT00742274
A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection
A study testing Gore TAG Endoprosthesis and Best Medical Therapy in people with Aortic Diseases, run by W.L.Gore & Associates.
Trial summary
The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Diseases
- What is being tested?
- Gore TAG Endoprosthesis and Best Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of acute uncomplicated type B aortic dissection
- Able to tolerate endotracheal intubation and general anesthesia
- Maximum transverse diameter of the descending thoracic aorta < 55 mm and absence of descending thoracic aortic aneurysm, regardless of etiology.
- Arterial anatomy is appropriate for stent graft therapy
Who cannot join
- ASA classification = V
- Severe renal insufficiency defined as SVS risk renal status = 3
- Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
- Presence of connective tissue disease
- Active infection or active vasculitides
- Positive pregnancy test
Show all 10Show fewer
- Participation in another medical research study within 3 months of study enrollment
- Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
- Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass), or major surgery within 30 days of study enrollment
- History of drug abuse
About this study
Official title: A Randomized European Study Comparing Endoluminal Stent Grafting and Best Medical Therapy (BMT) to BMT Alone in the Treatment of Acute Uncomplicated Type B Aortic Dissection
The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections.
Read the detailed description
Dissection of the aorta is a medical emergency requiring immediate surgery. Type B dissections are typically treated with surgery or endoluminal therapy when complications such as uncontrollable pain, organ ischemia, or aortic rupture are present. However, the treatment of patients with uncomplicated, acute type B dissections is controversial. Best medical therapy (BMT) is the standard of care in these cases since surgical repair offers no additional survival advantage. However, Endoluminal stent graft therapy with the GORE TAG Thoracic Endoprosthesis (GORE TAG device) may offer distinct advantages as an adjunct to medical therapy for uncomplicated acute type B dissection. The goal of endoluminal stent grafting is to cover the primary entry tear of the dissection to isolate the false lumen from blood flow and induce aortic remodeling.
- Conditions
- Aortic Diseases
- Being tested
- Gore TAG Endoprosthesis, Best Medical Therapy
- Medical subject headings
- Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gore TAG EndoprosthesisDevice
Implant Gore TAG device with Best Medical therapy per physician discretion
Best Medical TherapyOther
Best Medical therapy is regimen of antihypertensive medications used to maintain blood pressure below 125/80 mm/Hg throughout the entire follow-up period. Because BMT is assessed by blood pressure response to medication, specific medication regimens for each patient will differ. The typical regimen consists of 1 to 4 concomitant antihypertensive medications that may include angiotensin converting enzyme (ACE) inhibitors, alpha blockers, beta blockers, calcium channel blockers, diuretics, and/or vasodilators.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TAG+BMT Receives: Device: Gore TAG Endoprosthesis |
| 2 | Active comparator | BMT alone Receives: Other: Best Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation
Subjects with any of the following met this composite outcome:
- partial/no false lumen thrombosis
- aortic rupture
- aortic dilatation
- lack of 1 year imaging (no image, incomplete image missing primary endpoint measurements, unevaluable image)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 W.L.Gore & AssociatesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Brunkwall, MD, PhD, Principal investigator, Kilinkum der Universitat zu Koln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742274
- Sponsor's protocol ID
- TAG 05-04
- Acronym
- ADSORB
- Status last verified
- Nov 2013
- First submitted
- 25 Aug 2008
- Last updated
- 4 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Brunkwall J, Kasprzak P, Verhoeven E, Heijmen R, Taylor P; ADSORB Trialists; Alric P, Canaud L, Janotta M, Raithel D, Malina W, Resch T, Eckstein HH, Ockert S, Larzon T, Carlsson F, Schumacher H, Classen S, Schaub P, Lammer J, Lonn L, Clough RE, Rampoldi V, Trimarchi S, Fabiani JN, Bockler D, Kotelis D, Bockler D, Kotelis D, von Tenng-Kobligk H, Mangialardi N, Ronchey S, Dialetto G, Matoussevitch V. Endovascular repair of acute uncomplicated aortic type B dissection promotes aortic remodelling: 1 year results of the ADSORB trial. Eur J Vasc Endovasc Surg. 2014 Sep;48(3):285-91. doi: 10.1016/j.ejvs.2014.05.012. Epub 2014 Jun 22.
PubMed 24962744
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized European Study Comparing Endoluminal Stent Grafting and Best Medical Therapy (BMT) to BMT Alone in the Treatment of Acute Uncomplicated Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT00742274
- Acronym / sponsor ID
- ADSORB / TAG 05-04
- Conditions
- Aortic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Posted 9 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections.
Detailed description
Dissection of the aorta is a medical emergency requiring immediate surgery. Type B dissections are typically treated with surgery or endoluminal therapy when complications such as uncontrollable pain, organ ischemia, or aortic rupture are present. However, the treatment of patients with uncomplicated, acute type B dissections is controversial. Best medical therapy (BMT) is the standard of care in these cases since surgical repair offers no additional survival advantage. However, Endoluminal stent graft therapy with the GORE TAG Thoracic Endoprosthesis (GORE TAG device) may offer distinct advantages as an adjunct to medical therapy for uncomplicated acute type B dissection. The goal of endoluminal stent grafting is to cover the primary entry tear of the dissection to isolate the false lumen from blood flow and induce aortic remodeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Gore TAG EndoprosthesisTAG+BMT |
| 2 | Active comparator | Other: Best Medical TherapyBMT alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of acute uncomplicated type B aortic dissection
- Able to tolerate endotracheal intubation and general anesthesia
- Maximum transverse diameter of the descending thoracic aorta < 55 mm and absence of descending thoracic aortic aneurysm, regardless of etiology.
- Arterial anatomy is appropriate for stent graft therapy
Key exclusion criteria (10 listed)
- ASA classification = V
- Severe renal insufficiency defined as SVS risk renal status = 3
- Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
- Presence of connective tissue disease
- Active infection or active vasculitides
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 |
|---|---|---|
| Gore TAG EndoprosthesisImplant Gore TAG device with Best Medical therapy per physician discretion | Device | 1 |
| Best Medical TherapyBest Medical therapy is regimen of antihypertensive medications used to maintain blood pressure below 125/80 mm/Hg throughout the entire follow-up period. Because BMT is assessed by blood pressure response to medication, specific medication regimens for each patient will differ. The typical regimen consists of 1 to 4 concomitant antihypertensive medications that may include angiotensin converting enzyme (ACE) inhibitors, alpha blockers, beta blockers, calcium channel blockers, diuretics, and/or vasodilators. | Other | 2 |
Primary outcome
Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation
Time frame: 1 year
Subjects with any of the following met this composite outcome: * partial/no false lumen thrombosis * aortic rupture * aortic dilatation * lack of 1 year imaging (no image, incomplete image missing primary endpoint measurements, unevaluable image)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24962744Brunkwall J, Kasprzak P, Verhoeven E, Heijmen R, Taylor P; ADSORB Trialists; Alric P, Canaud L, Janotta M, Raithel D, Malina W, Resch T, Eckstein HH, Ockert S, Larzon T, Carlsson F, Schumacher H, Classen S, Schaub P, Lammer J, Lonn L, Clough RE, Rampoldi V, Trimarchi S, Fabiani JN, Bockler D, Kotelis D, Bockler D, Kotelis D, von Tenng-Kobligk H, Mangialardi N, Ronchey S, Dialetto G, Matoussevitch V. Endovascular repair of acute uncomplicated aortic type B dissection promotes aortic remodelling: 1 year results of the ADSORB trial. Eur J Vasc Endovasc Surg. 2014 Sep;48(3):285-91. doi: 10.1016/j.ejvs.2014.05.012. Epub 2014 Jun 22.
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.
Jan Brunkwall, MD, PhD principal investigator
Kilinkum der Universitat zu Koln
Questions about this trial
What is this clinical trial studying?
A study testing Gore TAG Endoprosthesis and Best Medical Therapy in people with Aortic Diseases, run by W.L.Gore & Associates.
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 4 inclusion and 10 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 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation (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 NCT00742274, which also lists 1 linked publication.
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 4 Dec 2013.