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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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anastomoses in blood vessels and grafts

Group Type ACTIVE_COMPARATOR

Anastomosis (C-Port® )

Intervention Type DEVICE

creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures

Interventions

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Anastomosis (C-Port® )

creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures

Intervention Type DEVICE

Other Intervention Names

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C-Port® Distal Anastomosis System C-Port® xA™ Distal Anastomosis System C-Port® FlexA™ Distal Anastomosis System C-Port® XCHANGE™ Distal Anastomosis System

Eligibility Criteria

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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.

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.

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No