Coronary Artery DiseaseNCT01386021
Saphenous Vein Allografts for Coronary Bypass
An observational study of Coronary Artery Disease and Occlusion of Artery, run by CryoLife, Inc. at 1 site in United States.
Trial summary
The primary objective of this observational study is to evaluate the function (patency) of cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for patients with occlusive coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Occlusion of Artery
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Nov 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having a previous implant of CryoVein Saphenous Vein allografts for CABG between 2008 - 2010, at a single instituion
Who may be able to join
- Any patient implanted with a CryoVein saphenous vein allograft for CABG during 2008 - 2010 time frame.
- Patients > 18 years of age at implant.
Who cannot join
- Patients < 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting
The primary objective of this observational study is to evaluate the function (patency) of cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for patients with occlusive coronary artery disease.
Read the detailed description
This Study is designed as a combination retrospective/prospective single center study in which all patients will be eligible for enrollment based on having a previous implant of CryoVein Saphenous Vein for CABG during the 2008-2010 time frame. A comprehensive chart review of former and previously implanted allograft patients will be performed for the retrospective portion of this Study. An effort will be made to include all patients from this site. Eligible patients will be consented into the Study for a single, prospective, observational imaging evaluation of their bypass conduits.
- Conditions
- Coronary Artery Disease, Occlusion of Artery
- Keywords
- allograft, coronary, patency, morbidity
- Medical subject headings
- Coronary Artery Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prior recipients of allografts for CABG | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Patency
Measured: 1 to 3 years as defined by the date of their incident operation (CABG surgery).
Secondary outcomes (1)
Morbidity
Measured: 1 to 3 years defined by the date of their incident operation (CABG surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionNov 2011
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
- Observational
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- CryoLife, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valavanur A Subramanian, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386021
- Sponsor's protocol ID
- AVG1101.001-M
- Status last verified
- Dec 2011
- First submitted
- 29 Jun 2011
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01386021
- Acronym / sponsor ID
- AVG1101.001-M
- Conditions
- Coronary Artery Disease, Occlusion of Artery
- Keywords
- allograft, coronary, patency, morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CryoLife, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Jun 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 primary objective of this observational study is to evaluate the function (patency) of cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for patients with occlusive coronary artery disease.
Detailed description
This Study is designed as a combination retrospective/prospective single center study in which all patients will be eligible for enrollment based on having a previous implant of CryoVein Saphenous Vein for CABG during the 2008-2010 time frame. A comprehensive chart review of former and previously implanted allograft patients will be performed for the retrospective portion of this Study. An effort will be made to include all patients from this site. Eligible patients will be consented into the Study for a single, prospective, observational imaging evaluation of their bypass conduits.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prior recipients of allografts for CABG | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a previous implant of CryoVein Saphenous Vein allografts for CABG between 2008 - 2010, at a single instituion
Key inclusion criteria (2 listed)
- Any patient implanted with a CryoVein saphenous vein allograft for CABG during 2008 - 2010 time frame.
- Patients > 18 years of age at implant.
Key exclusion criteria (1 listed)
- Patients < 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Graft Patency
Time frame: 1 to 3 years as defined by the date of their incident operation (CABG surgery).
1 secondary outcome
Morbidity
Time frame: 1 to 3 years defined by the date of their incident operation (CABG surgery)
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 21 Dec 2011.
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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.
Valavanur A Subramanian, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Occlusion of Artery, run by CryoLife, 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 2 inclusion and 1 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 21 Dec 2011. 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.
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 (time frame: 1 to 3 years as defined by the date of their incident operation (CABG surgery).). 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 Dec 2011.