Heart DiseasePhase 4NCT01478061
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
A Phase 4 study testing Anastomosis (C-Port® ) in people with Heart Disease, run by Cardica, Inc at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Disease
- What is being tested?
- Anastomosis (C-Port® )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2009to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 21Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Akron General Medical Center
Akron, Ohio, 44307
Cardiopulmonary Research Science & Technology Institute
Dallas, Texas, 75230
Genesis Medical Center
Davenport, Iowa, 52803
Methodist Hospital - Houston
Houston, Texas, 77030
University of Arkansas
Little Rock, Arkansas, 72205
Lenox Hill Hospital
New York, New York, 10075
Wisconsin Heart
Wauwatosa, Wisconsin, 53226
About this study
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.
Read the 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:
- 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.
- Technical failure rates when attempting to complete an anastomosis using the C-Port xA, FlexA, and XCHANGE Distal Anastomosis Systems.
- 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.
- Conditions
- Heart Disease
- Being tested
- Anastomosis (C-Port® )
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastomosis (C-Port® )Device
Also called C-Port® Distal Anastomosis System, C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System, C-Port® XCHANGE™ Distal Anastomosis System
creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures
| Study group | Role | What they receive |
|---|---|---|
| anastomoses in blood vessels and grafts | Active comparator | Not described Receives: Device: Anastomosis (C-Port® ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.
- Acute, midterm, and one-year graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.
Measured: 12 months
Secondary outcomes (2)
Technical Failure Rates
Technical failure rates when completing an anastomosis using the C-Port products.
Measured: 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.
Measured: Day 1 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startApr 2009
- Primary completionJan 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardica, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Husam Balkhy, MD, Principal investigator, Wisconsin Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478061
- Sponsor's protocol ID
- CP2007-01
- Status last verified
- Jul 2015
- First submitted
- 19 Oct 2011
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
- ClinicalTrials.gov ID
- NCT01478061
- Acronym / sponsor ID
- CP2007-01
- Conditions
- Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Cardica, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Technical failure rates when attempting to complete an anastomosis using the C-Port xA, FlexA, and XCHANGE Distal Anastomosis Systems.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anastomoses in blood vessels and grafts | Active comparator | Device: Anastomosis (C-Port® ) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anastomosis (C-Port® )Also: C-Port® Distal Anastomosis System, C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System, C-Port® XCHANGE™ Distal Anastomosis Systemcreation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures | Device | anastomoses in blood vessels and grafts |
Primary outcome
Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.
Time frame: 12 months
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.
2 secondary outcomes
Technical Failure Rates
Time frame: Day 1
Technical success rate of hand-sewn
Time frame: Day 1 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Husam Balkhy, MD principal investigator
Wisconsin Heart Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anastomosis (C-Port® ) in people with Heart Disease, run by Cardica, Inc at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.