Coronary Artery DiseaseNCT00292500
Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
A study testing Automated distal anastomotic device in people with Coronary Artery Disease, run by Cardica, Inc at 1 site in Germany.
Trial summary
This evaluation is designed to evaluate the feasibility of using an automated distal coronary anastomotic to facilitate grafting of the left internal mammary artery to the left anterio descending coronary artery during myocardial revascularization in patients with coronary artery disease requiring surgical… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Automated distal anastomotic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Dec 2009
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 85 years (inclusive)
- Diagnostically confirmed coronary disease
- Ejection fraction > 30%
- Tolerate contrast media
- Acceptable LIMA (conduit) and LAD (target)for grafting
- Life expectancy > 1 year
Who cannot join
- Refusal to give informed consent
- Unable to meet study travel and general health requirements
- Pregnancy
- Previous cardiac surgery
- NYHA Class IV
- Preoperative need for IABP
Show all 11Show fewer
- Acute or chronic dialysis (creatinine > 200mmolor 2.3 mg/dL) within 30 days of surgery
- Acute or suspected systemic infection
- Need for ongoing immunosuppressive therapy
- Recent history (<2 weeks) of CVA
- Aspirin allergy
Trial locations and contacts
1 site in 1 country.
About this study
This evaluation is designed to evaluate the feasibility of using an automated distal coronary anastomotic to facilitate grafting of the left internal mammary artery to the left anterio descending coronary artery during myocardial revascularization in patients with coronary artery disease requiring surgical intervention. The study is designed to assess the ability to compare the patency of grafts created using an automated device versus hand-sewn grafts of the same vessels in the same patient population.
Read the detailed description
Evaluation of automated distal anastomotic device as a surrogate for hand-sewn grafts for completion of arterial conduit anastomosis between the Left Internal Mammary Artery and Left Anterior Descending Artery among patients with coronary artery disease requiring surgical revascularization.
- Conditions
- Coronary Artery Disease
- Being tested
- Automated distal anastomotic device
- Keywords
- CABG, anastomotic device; myocardial revascularization
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated distal anastomotic deviceDevice
Also called C-Port xA Distal Anastomosis System
CABG
| Study group | Role | What they receive |
|---|---|---|
| C-Port | No intervention | Automated distal anastomotic device Receives: Device: Automated distal anastomotic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary patency of index graft at the sixth post-operative month
Measured: 6 months post-op
Secondary outcomes (1)
Establish preliminary safety profile
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2008
- Study completionDec 2009
Why it stopped: Cardica has terminated the development of the product for Business Reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardica, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Gummert, MD, Principal investigator, Herzzentrum Leipzig Gmbh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292500
- Sponsor's protocol ID
- IP2004-06
- Status last verified
- Aug 2013
- First submitted
- 14 Feb 2006
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
- ClinicalTrials.gov ID
- NCT00292500
- Acronym / sponsor ID
- IP2004-06
- Conditions
- Coronary Artery Disease
- Keywords
- CABG, anastomotic device; myocardial revascularization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cardica has terminated the development of the product for Business Reason.
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Cardica, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Feb 2006 (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.
This evaluation is designed to evaluate the feasibility of using an automated distal coronary anastomotic to facilitate grafting of the left internal mammary artery to the left anterio descending coronary artery during myocardial revascularization in patients with coronary artery disease requiring surgical intervention. The study is designed to assess the ability to compare the patency of grafts created using an automated device versus hand-sewn grafts of the same vessels in the same patient population.
Detailed description
Evaluation of automated distal anastomotic device as a surrogate for hand-sewn grafts for completion of arterial conduit anastomosis between the Left Internal Mammary Artery and Left Anterior Descending Artery among patients with coronary artery disease requiring surgical revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-Port | No intervention | Device: Automated distal anastomotic deviceAutomated distal anastomotic device |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 50 and 85 years (inclusive)
- Diagnostically confirmed coronary disease
- Ejection fraction > 30%
- Tolerate contrast media
- Acceptable LIMA (conduit) and LAD (target)for grafting
Key exclusion criteria (11 listed)
- Refusal to give informed consent
- Unable to meet study travel and general health requirements
- Pregnancy
- Previous cardiac surgery
- NYHA Class IV
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 |
|---|---|---|
| Automated distal anastomotic deviceAlso: C-Port xA Distal Anastomosis SystemCABG | Device | C-Port |
Primary outcome
Coronary patency of index graft at the sixth post-operative month
Time frame: 6 months post-op
1 secondary outcome
Establish preliminary safety profile
Time frame: 6 months post-op
Results and safety
The study was stopped early (reason given: Cardica has terminated the development of the product for Business Reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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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.
Jan Gummert, MD principal investigator
Herzzentrum Leipzig Gmbh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated distal anastomotic device in people with Coronary Artery Disease, run by Cardica, Inc at 1 site in Germany.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
Are results available for this study?
The study was stopped early (reason given: Cardica has terminated the development of the product for Business Reason.). Results are not available in the source record.
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?
Coronary patency of index graft at the sixth post-operative month (time frame: 6 months post-op). 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 21 Aug 2013.