Coronary Artery DiseaseOPTIONNCT01697176
Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
An observational study of Coronary Artery Disease, run by Cardiopulmonary Research Science and Technology Institute at 2 sites in United States.
Trial summary
This is an observational study of lone Coronary Artery Bypass Grafting procedures with endoscopic vein graft harvesting using best harvesting practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Aug 2014
- 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: Primary Isolated CABG
Who may be able to join
- Age greater than 18 and able to provide consent
- Eligible for endoscopic vein harvesting
- Minimum of two non sequential vein grafts
- Willing to comply with requirements of protocol
Who cannot join
- Previous CABG
- Previous or concomitant valve surgery
- Any other concomitant cardiac procedure other than surgical ablation or incidental PFO repair
- Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication
- Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent
- Abnormal platelet level defined as Plt Count >400,000
Show all 9Show fewer
- Abnormal platelet function (hypercoagulable state) as evidenced by TEG testing
- Allergy to or presence of a condition that the investigator feels may prevent safe administration of ASA or Plavix post-operatively.
- Patient has a co-morbid condition that in the opinion of the investigator poses undue risk for successful endovascular harvesting of the vein
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CRSTI/Medical City Dallas
Dallas, Texas, 75230
The Heart Hospital Baylor Plano
Plano, Texas, 75093
About this study
Official title: A 1-year Prospective, Multicenter, Non-Randomized, Observational, Study to Evaluate Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
This is an observational study of lone Coronary Artery Bypass Grafting procedures with endoscopic vein graft harvesting using best harvesting practices.
Read the detailed description
This is a prospective, multi-center, non-randomized, observational study of 100 patients who will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone Coronary Artery Bypass Graft (CABG) procedures with endoscopic vein harvesting using best harvesting practices, defined as: systemic heparinization prior to vein manipulation, standardization of vein graft harvesting techniques, pressure limiting syringe and 3 month use of dual anti-platelet therapy. Patients will undergo a CT angiography at 30 days and 12 months to assess vein graft patency.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
To demonstrate improved vein graft patency rates at 12 months for endoscopically harvest saphenous vein grafts by employment of modifications to existing techniques in vein graft handling during harvests. Vein graft patency will be measured at 30 days post CABG and at one year post CABG as evaluated by cardiac CT angiography or cardiac catheterization.
Measured: 12 months
Secondary outcomes (1)
OPTION
To develop a standardized approach for harvesting, handling and preparing vein grafts in the endoscopic approach. By capturing the following:
- Incidence of vein graft failure at the time of initial CABG as evaluated by transit time graft flow measurements
- Incidence of vein graft failure at post-operative day 30 as evaluated by cardiac CT angiography or cardiac catheterization
- Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:
- Harvested vessel
- vein graft destinations
- vein graft quality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startAug 2010
- Primary completionAug 2014
- Study completionAug 2014
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiopulmonary Research Science and Technology Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Maquet Cardiovascular
- Responsible party
- Sponsor
- Investigators
- David Moore, MD, Principal investigator, The Heart Hospital Baylor PlanoMichael J Mack, MD, Principal investigator, Cardiopulmonary Research Science and Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697176
- Sponsor's protocol ID
- OPTION
- Acronym
- OPTION
- Status last verified
- Sep 2012
- First submitted
- 17 Feb 2012
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-year Prospective, Multicenter, Non-Randomized, Observational, Study to Evaluate Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
- ClinicalTrials.gov ID
- NCT01697176
- Acronym / sponsor ID
- OPTION / OPTION
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cardiopulmonary Research Science and Technology InstituteUniversity, hospital or other
- Collaborators
- Maquet Cardiovascular
- Study start
- Aug 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Oct 2012 (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 is an observational study of lone Coronary Artery Bypass Grafting procedures with endoscopic vein graft harvesting using best harvesting practices.
Detailed description
This is a prospective, multi-center, non-randomized, observational study of 100 patients who will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone Coronary Artery Bypass Graft (CABG) procedures with endoscopic vein harvesting using best harvesting practices, defined as: systemic heparinization prior to vein manipulation, standardization of vein graft harvesting techniques, pressure limiting syringe and 3 month use of dual anti-platelet therapy. Patients will undergo a CT angiography at 30 days and 12 months to assess vein graft patency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Isolated CABG
Key inclusion criteria (4 listed)
- Age greater than 18 and able to provide consent
- Eligible for endoscopic vein harvesting
- Minimum of two non sequential vein grafts
- Willing to comply with requirements of protocol
Key exclusion criteria (9 listed)
- Previous CABG
- Previous or concomitant valve surgery
- Any other concomitant cardiac procedure other than surgical ablation or incidental PFO repair
- Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication
- Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent
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
Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
Time frame: 12 months
To demonstrate improved vein graft patency rates at 12 months for endoscopically harvest saphenous vein grafts by employment of modifications to existing techniques in vein graft handling during harvests. Vein graft patency will be measured at 30 days post CABG and at one year post CABG as evaluated by cardiac CT angiography or cardiac catheterization.
1 secondary outcome
OPTION
Time frame: 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 Oct 2014.
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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.
David Moore, MD principal investigator
The Heart Hospital Baylor Plano
Michael J Mack, MD principal investigator
Cardiopulmonary Research Science and Technology Institute
2 sites 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, run by Cardiopulmonary Research Science and Technology Institute at 2 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 4 inclusion and 9 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 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques (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 Oct 2014.