Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device

Cardica

Status and phase: Completed; Phase 4

Conditions: Heart Disease

Treatments: Device: Anastomosis (C-Port® )

Study type: Interventional

Funder types: Industry

Identifiers

NCT01478061

CP2007-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

anastomoses in blood vessels and grafts

Active Comparator group

Treatment:

Device: Anastomosis (C-Port® )