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.

Study Overview

• Status: Completed
• Conditions: Heart Disease
• Intervention / Treatment: Device: Anastomosis (C-Port® )

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Genesis Medical Center
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • Ohio
    • Akron, Ohio, United States, 44307
      • Akron General Medical Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Cardiopulmonary Research Science & Technology Institute
    • Houston, Texas, United States, 77030
      • Methodist Hospital - Houston
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Wisconsin Heart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Failure Rates	Technical failure rates when completing an anastomosis using the C-Port products.	Day 1
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.	Day 1 and 12 months

Collaborators and Investigators

• Sponsor: Cardica, Inc
• Investigators: Principal Investigator: Husam Balkhy, MD, Wisconsin Heart Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: November 21, 2011
• First Posted (Estimate): November 23, 2011

Study Record Updates

• Last Update Posted (Estimate): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CP2007-01