Coronary Artery DiseasePhase 3EPICNCT00355563
Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery
A Phase 3 study testing PAS-Port Automated Proximal Anastomosis System in people with Coronary Artery Disease, run by Cardica, Inc at 1 site in United States.
Trial summary
The study has been designed to comparatively evaluate the safety and effectiveness of the PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the connection between graft veins and the aorta in patients undergoing coronary artery bypass graft surgery for treatment of coronary… 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?
- PAS-Port Automated Proximal Anastomosis System
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Apr 2008
- Phase
- Phase 3
- 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
- Able to give informed consent, able to understand the intent and clinical meaning of the study as well as its implications. Patient is legally competent.
- Assessment that the patient is willing and able to have follow-up visits and examinations
- Age greater than or equal to 50 years and less than 85 years
- Ejection fraction of >30%
- Can tolerate radiographic contrast media
- Requires non-emergent coronary artery bypass with at least two vein bypass grafts intended
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- Coronary artery targets intended for bypass index grafts must have >70% native stenosis
- Life expectancy >1 year
- Patient is hemodynamically stable
- Open chest reassessment of the revascularization strategy confirms that two vein bypass grafts are still intended
- Target vessel wall properties that are suitable for performing both a hand-sewn and a PAS-Port anastomosis
- Target vessel is greater than 1.8 mm in diameter at sites where anastomoses are planned
- Target vessel at sites where anastomoses will be placed are free from severe calcifications or severe atheromas
- The length of the vein graft(s) is adequate for both of the planned index graft revascularization strategies
- Vein outside diameter and double wall thickness are between 4 and 6 mm(inclusive) and less than or equal to 1.4 mm, respectively, at the graft site intended for the PAS-Port proximal anastomosis
- The vein(s) is of suitable quality to be used as a bypass graft conduit
Who cannot join
- Patient is participating in other clinical trials that would conflict with this protocol
- Unable to meet study requirements (travel, general health)
- Pregnancy
- Previous cardiac surgery
- Requiring preoperative use of an intraaortic balloon pump
- Congestive heart failure / NYHA Class IV
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- History of thromboembolic disease requiring ongoing anticoagulation therapy or the presence of a bleeding disorder
- Acute or chronic dialysis
- Creatinine of greater than 200 µmol/L (2.3 mg/dL) in the last 30 days
- Documented acute or suspected systemic infection
- Need for ongoing immunosuppressive therapy
- Recent (less than 2 weeks) history of cerebrovascular accident
- Aspirin allergy or other contraindications to aspirin use
- INTRA-OPERATIVELY
- -Any of the Intra-operative Inclusion Criteria not met
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Michael's Medical Center
Newark, New Jersey, 07102
About this study
Official title: Use of the PAS-Port Proximal Anastomosis System for Creation of Aorto-Venous Proximal Anastomoses in Coronary Bypass Surgery
The study has been designed to comparatively evaluate the safety and effectiveness of the PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the connection between graft veins and the aorta in patients undergoing coronary artery bypass graft surgery for treatment of coronary artery disease. Patients in the study will have a coronary angiogram approximately 9 months following surgery to determine the patency of vein grafts created using either the automated PAS-Port or hand sewn methods. Safety will be evaluated by documenting the occurence of adverse clinical events and evealuating possible association with either method.
- Conditions
- Coronary Artery Disease
- Being tested
- PAS-Port Automated Proximal Anastomosis System
- 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.
PAS-Port Automated Proximal Anastomosis SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Graft Patency at 9 months post-operatively
Safety: Peri-and Post-operative MACE and SAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionApr 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardica, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Puskas, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355563
- Sponsor's protocol ID
- IP2005-07
- Acronym
- EPIC
- Status last verified
- Jan 2009
- First submitted
- 21 Jul 2006
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the PAS-Port Proximal Anastomosis System for Creation of Aorto-Venous Proximal Anastomoses in Coronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT00355563
- Acronym / sponsor ID
- EPIC / IP2005-07
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Cardica, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 24 Jul 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.
The study has been designed to comparatively evaluate the safety and effectiveness of the PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the connection between graft veins and the aorta in patients undergoing coronary artery bypass graft surgery for treatment of coronary artery disease. Patients in the study will have a coronary angiogram approximately 9 months following surgery to determine the patency of vein grafts created using either the automated PAS-Port or hand sewn methods. Safety will be evaluated by documenting the occurence of adverse clinical events and evealuating possible association with either method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Able to give informed consent, able to understand the intent and clinical meaning of the study as well as its implications. Patient is legally competent.
- Assessment that the patient is willing and able to have follow-up visits and examinations
- Age greater than or equal to 50 years and less than 85 years
- Ejection fraction of >30%
- Can tolerate radiographic contrast media
Key exclusion criteria (15 listed)
- Patient is participating in other clinical trials that would conflict with this protocol
- Unable to meet study requirements (travel, general health)
- Pregnancy
- Previous cardiac surgery
- Requiring preoperative use of an intraaortic balloon pump
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 |
|---|---|---|
| PAS-Port Automated Proximal Anastomosis System | Device | – |
Primary outcome
Effectiveness: Graft Patency at 9 months post-operatively
Safety: Peri-and Post-operative MACE and SAE
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 9 Jan 2009.
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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.
John Puskas, M.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PAS-Port Automated Proximal Anastomosis System in people with Coronary Artery Disease, run by Cardica, Inc at 1 site 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 16 inclusion and 15 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 9 Jan 2009. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Effectiveness: Graft Patency at 9 months post-operatively. The study lists 2 primary outcomes in all. 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 9 Jan 2009.