NCT01478061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

October 19, 2011

Last Update Submit

July 20, 2015

Conditions

Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Technical Failure Rates

    Day 1

  • Technical success rate of hand-sewn

    Day 1 and 12 months

Study Arms (1)

anastomoses in blood vessels and grafts

ACTIVE COMPARATOR
Device: Anastomosis (C-Port® )

Interventions

Anastomosis (C-Port® )DEVICE

creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures

Also known as: C-Port® Distal Anastomosis System, C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System, C-Port® XCHANGE™ Distal Anastomosis System
anastomoses in blood vessels and grafts

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Cardiopulmonary Research Science & Technology Institute

Dallas, Texas, 75230, United States

Location

Methodist Hospital - Houston

Houston, Texas, 77030, United States

Location

Wisconsin Heart

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Anastomosis, Surgical

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Husam Balkhy, MD

    Wisconsin Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2011

First Posted

November 23, 2011

Study Start

April 1, 2009

Primary Completion

January 1, 2013

Study Completion

July 1, 2015

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations

US(7)