N/A
N=61
A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection
Aortic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00742274 ↗Enrolled (actual)
61
Serious AEs
47.5%
Results posted
May 2013
Primary outcome: Primary: Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation — 15; 31 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gore TAG Endoprosthesis (Device); Best Medical Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation |
15; 31 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00742274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.