Clinical comparison between a manual suture and a sutureless coupling device (corVCD) connecting the subclavian artery with a 4-finger graft in a complete aortic arch replacement

Not Applicable

Completed

• Conditions: Vascular diseases like chronic dissections or aneurysms in the area of the aortic arch and the supra-aortic vessels; Surgery

• Registration Number: ISRCTN14209306
• Lead Sponsor: Corlife OHG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-23
• Study Completion: 2016-09-30
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.<br>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.