Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | April 2009 |
| End Date: | July 2015 |
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.
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:
1. Acute, midterm, and one-year graft failure rates for coronary revascularization using
the C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System,
and C-Port® XCHANGE™ Distal Anastomosis System when in general use in the United States
compared to hand-sewn anastomoses.
2. Technical failure rates when attempting to complete an anastomosis using the C-Port xA,
FlexA, and XCHANGE Distal Anastomosis Systems.
3. The technical success rate of hand-sewn anastomoses following technical failures of the
C-Port devices and the hand-sewn graft patency rates and clinical sequelae at one year.
FDA to Cardica, Inc., the following outcomes will be evaluated:
1. Acute, midterm, and one-year graft failure rates for coronary revascularization using
the C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System,
and C-Port® XCHANGE™ Distal Anastomosis System when in general use in the United States
compared to hand-sewn anastomoses.
2. Technical failure rates when attempting to complete an anastomosis using the C-Port xA,
FlexA, and XCHANGE Distal Anastomosis Systems.
3. The technical success rate of hand-sewn anastomoses following technical failures of the
C-Port devices and the hand-sewn graft patency rates and clinical sequelae at one year.
Inclusion Criteria:
- Able to give informed consent.
- Willing and able to have follow-up visits and examinations.
- Less than 80 years old.
- Have an ejection fraction of >30 %.
- Have a life expectancy of >1 year.
Pre-Operative Exclusion Criteria:
- Currently participating in other clinical trials that would conflict with this
protocol.
- Unable to meet study requirements.
- Currently pregnant.
- Require preoperative use of an intraaortic balloon pump.
- Have a history of a bleeding disorder or history of a thromboembolic disease
requiring anticoagulation therapy.
- Have congestive heart failure or been classified as NYHA Class IV.
- Have an aspirin allergy or other contraindications to aspirin use.
- Previous coronary artery bypass surgery.
- Vasculitis or other nonatherosclerotic cause for coronary artery disease.
Intra-Operative Exclusion Criteria:
- At least one target vessel site where the C-Port anastomosis will be placed that is
free from severe calcification or severe atheromas
- Target vessel wall properties where the C-Port anastomosis will be placed are
suitable for hand-sewn anastomosis
- Target vessel diameter is ≥ 1.3 mm
- Target vessel has a single wall thickness ≤ 0.75mm
- Hemodynamically stable
We found this trial at
7
sites
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Akron General Medical Center It
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