IRB Study Number 22-532
Status Recruiting
Phase Phase 1
Locations J Building - Sydell & Arnold Miller Family Pavilion, Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The purpose of this study is to find out if AMDS is safe and effective in the treatment of acute dissection (sudden tear). For patients whose aortic anatomy is suitable for treatment with AMDS, the use of this device may promote healing of the aortic walls and possibly reduce the need for additional aortic surgeries. If conventional surgery, in combination with AMDS, is effective, it is believed that this could lead to improved aortic healing; an improvement in healing could reduce the risk of hospitalization and reoperation in the chest compared to conventional surgery alone.
If you choose to participate in this research study, you have certain responsibilities that may apply to this study, such as ensuring that you arrive at all your scheduled appointments and report any medical problems (adverse events), you may have during the study. Participation in this study will last approximately five years from your date of surgery. Your participation in this research study will involve regular follow-up visits with your doctor. These visits will be scheduled as a pre-operative visit, a surgical visit, and seven post-operative follow-up appointments at 30 days, 3-6 months, and then annually thereafter for 5 years after your surgery
Inclusion Criteria
- ≥18 years of age or ≤80 years of age (male or female) at time of surgery
- Acute DeBakey type I dissection
- Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)
Exclusion Criteria
- Other medical condition that is associated with limited life expectancy <2 years (e.g., cancer, congestive heart failure)
- Pregnant or breastfeeding /Unwilling to comply with the follow-up schedule
- Coronary malperfusion.
