Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Study plan is a post-market prospective, multi-center, open-label registry. The vein graft failure rates for the currently commercialized C-Port devices will be compared to an a priori rate taken from the peer-reviewed literature.
To satisfy the requirements set forth in post-market surveillance orders issued by the US FDA to Cardica, Inc., the following outcomes will be evaluated:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anastomoses in blood vessels and grafts | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastomosis (C-Port® ) | Device | creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses. | a. Acute, midterm, and one-year graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Failure Rates | Technical failure rates when completing an anastomosis using the C-Port products. | Day 1 |
| Technical success rate of hand-sewn | The technical success rate of hand-sewn anastomoses following technical failures of the C-Port products and the hand-sewn graft patency rates and clinical sequelae at one year. |
Not provided
Inclusion Criteria:
Pre-Operative Exclusion Criteria:
Intra-Operative Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Husam Balkhy, MD | Wisconsin Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas | Little Rock | Arkansas | 72205 | United States | ||
| Genesis Medical Center |
Not provided
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 1 and 12 months |
| Davenport |
| Iowa |
| 52803 |
| United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Cardiopulmonary Research Science & Technology Institute | Dallas | Texas | 75230 | United States |
| Methodist Hospital - Houston | Houston | Texas | 77030 | United States |
| Wisconsin Heart | Wauwatosa | Wisconsin | 53226 | United States |