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

October 19, 2011
October 10, 2013
April 2009
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01478061 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device

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.

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.
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Disease
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
Active Comparator: anastomoses in blood vessels and grafts
Intervention: Device: Anastomosis (C-Port® )
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
115
January 2014
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01478061
CP2007-01
No
Cardica, Inc
Cardica, Inc
Not Provided
Principal Investigator: Husam Balkhy, MD Wisconsin Heart Hospital
Cardica, Inc
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP