search
Back to results

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

Primary Purpose

Heart Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Anastomosis (C-Port® )
Sponsored by
Cardica, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas
  • Genesis Medical Center
  • Lenox Hill Hospital
  • Akron General Medical Center
  • Cardiopulmonary Research Science & Technology Institute
  • Methodist Hospital - Houston
  • Wisconsin Heart

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

anastomoses in blood vessels and grafts

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Technical Failure Rates
Technical failure rates when completing an anastomosis using the C-Port products.
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.

Full Information

First Posted
October 19, 2011
Last Updated
July 20, 2015
Sponsor
Cardica, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT01478061
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardica, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. Technical failure rates when attempting to complete an anastomosis using the C-Port xA, FlexA, and XCHANGE Distal Anastomosis Systems. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anastomoses in blood vessels and grafts
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Anastomosis (C-Port® )
Other Intervention Name(s)
C-Port® Distal Anastomosis System, C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System, C-Port® XCHANGE™ Distal Anastomosis System
Intervention Description
creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures
Primary Outcome Measure Information:
Title
Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical Failure Rates
Description
Technical failure rates when completing an anastomosis using the C-Port products.
Time Frame
Day 1
Title
Technical success rate of hand-sewn
Description
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.
Time Frame
Day 1 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Husam Balkhy, MD
Organizational Affiliation
Wisconsin Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Cardiopulmonary Research Science & Technology Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Methodist Hospital - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wisconsin Heart
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs