Vascular diseases like chronic dissections or aneurysms in the area of the aortic arch and the supra-aortic vessels Surgery
Conditions
Interventions
The aortic arch prosthesis is surgically implanted via a sternotomy under general anesthesia. Initially the aortic arch with its supra-aortic vessels are prepared.
The aortic arch prosthesis is made
Sponsors
Corlife OHG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with aneurysms (aortic caliber =5.5 cm) or chronic dissections in the area of the aortic arch with indication of an open surgery with an aortic arch prosthesis regarding ACCF/AHA guideline. 2. Patient suitable for operation 3. The patient has opted for an open surgery after deliberating about different available procedures 4. An inner diameter of the Arteria subclavia sinistra of 6.1 to 12.5 mm 5. Serum creatinine = 1.8 mg/dl 6. Estimated life expectancy > 5 years 7. Patient aged 18 to 80 years 8. Written consent form for study participation
Exclusion criteria
Exclusion criteria: 1. Patient cannot undergo an open surgery with circulatory arrest 2. Acute aortic dissection 3. Previous radiation treatment of the target region 4. Local or systemic infections 5. Pre-terminal renal insufficiency (serum creatinine > 1.8 mg/dl) or contrast agent intolerance 6. Conditions in the target region which inhibit an application of prosthetic material 7. Any other life-limiting disease (with an estimated life expectancy < 5 years) 8. Patient age = 18 or = 80 years 9. Pregnancy or lactation 10. Any other disease or medical treatment which interferes with safety or efficacy after assessment of the investigator 11. Patients who are in a dependency relationship or employment with the sponsor or investigator 12. Patients who are unable to give written consent for study participation 13. Concurrent participation in another clinical study 14. Hypersensitivity or allergy against nickel or titanium 15. Hypersensitivity against suture material 16. Absence of a written consent form for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The circulatory arrest time of 30± 10 min should be reduced to 20±10 min by the use of corVCD. The verification takes place by time recording. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. With the use of corVCD the time needed to reach a blood-dry anastomosis of the left subclavian artery should be reduced contrary to the application of a conventional suture. The verification takes place by time recording. 2. Potential occurring adverse events (AE) and serious adverse events (SAE) should be less by the use of corVCD in a period of 12 months after surgery. | — |
Countries
Germany
Outcome results
None listed