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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cardica, Inc
ClinicalTrials.gov Identifier:
NCT01478061
First received: October 19, 2011
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Heart Disease
Device: Anastomosis (C-Port® )
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device

Resource links provided by NLM:


Further study details as provided by Cardica, Inc:

Primary Outcome Measures:
  • Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Technical failure rates when completing an anastomosis using the C-Port products.

  • Technical success rate of hand-sewn [ Time Frame: Day 1 and 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 115
Study Start Date: April 2009
Estimated Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: anastomoses in blood vessels and grafts Device: Anastomosis (C-Port® )
creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures
Other Names:
  • C-Port® Distal Anastomosis System
  • C-Port® xA™ Distal Anastomosis System
  • C-Port® FlexA™ Distal Anastomosis System
  • C-Port® XCHANGE™ Distal Anastomosis System

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478061

Locations
United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72205
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52803
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10075
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
United States, Texas
Cardiopulmonary Research Science & Technology Institute
Dallas, Texas, United States, 75230
Methodist Hospital - Houston
Houston, Texas, United States, 77030
United States, Wisconsin
Wisconsin Heart
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Cardica, Inc
Investigators
Principal Investigator: Husam Balkhy, MD Wisconsin Heart Hospital
  More Information

No publications provided

Responsible Party: Cardica, Inc
ClinicalTrials.gov Identifier: NCT01478061     History of Changes
Other Study ID Numbers: CP2007-01
Study First Received: October 19, 2011
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014