Clinical trial NCT01478061: Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
Official title: Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Disease
Lead sponsor: Cardica, Inc
Sponsor class: INDUSTRY
First posted: 2011-11-23
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.
timeFrame: 12 months
Secondary outcomes:
measure: Technical Failure Rates
timeFrame: Day 1
measure: Technical success rate of hand-sewn
timeFrame: Day 1 and 12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Dallas
country: United States
facility: Cardiopulmonary Research Science & Technology Institute
state: Texas
city: Houston
country: United States
facility: Methodist Hospital - Houston
state: Texas
city: Wauwatosa
country: United States
facility: Wisconsin Heart
state: Wisconsin
Study officials:
affiliation: Wisconsin Heart Hospital
name: Husam Balkhy, MD
role: PRINCIPAL_INVESTIGATOR
References: