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

Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478061
• Other study ID #: CP2007-01
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2011
• Last updated: July 20, 2015
• Start date: April 2009
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Cardica, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Disease

Intervention

Device:
• Anastomosis (C-Port® )
creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures

Locations

Country	Name	City	State
United States	Akron General Medical Center	Akron	Ohio
United States	Cardiopulmonary Research Science & Technology Institute	Dallas	Texas
United States	Genesis Medical Center	Davenport	Iowa
United States	Methodist Hospital - Houston	Houston	Texas
United States	University of Arkansas	Little Rock	Arkansas
United States	Lenox Hill Hospital	New York	New York
United States	Wisconsin Heart	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Cardica, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Technical Failure Rates	Technical failure rates when completing an anastomosis using the C-Port products.	Day 1	No
Secondary	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	No