Coronary Artery DiseaseNCT01540422
Study to Improve Long Term Vein Graft Patency After Coronary Bypass Surgery by Using a Novel Endoscopic Harvesting Technique
An observational study of Coronary Artery Disease, run by Baylor Research Institute at 2 sites in United States.
Trial summary
The purpose of this study is to demonstrate improved vein graft patency rates at 12 months for endoscopically harvested saphenous vein grafts. The study will evaluate use modifications to existing techniques in vein graft handling during harvests. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 93 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Jun 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Hospital facility
Who may be able to join
- Males and females at least 18 years of age and able to sign consent
- Undergoing CABG surgery
- Eligible for endoscopic saphenous vein harvesting
- A minimum of two non-sequential vein grafts will be performed
- Subject willing to comply with the requirements of the 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
Medical City Hospital
Dallas, Texas, 75230
The Heart Hospital Baylor Plano
Plano, Texas, 75093
About this study
Official title: OPTION Trial: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
The purpose of this study is to demonstrate improved vein graft patency rates at 12 months for endoscopically harvested saphenous vein grafts. The study will evaluate use modifications to existing techniques in vein graft handling during harvests. A secondary aim is to develop a standardized approach for harvesting, handling, and preparing vein grafts in the endoscopic approach.
Read the detailed description
Available data supports two facts: 1) Saphenous vein graft failure rates may be as high as 47% per patient at one year post coronary artery bypass grafting, and 2) Endoscopic vein-graft harvesting is independently associated with vein-graft failure and adverse clinical outcomes.
Multiple factors may contribute to the lower long term patency rates of endoscopically harvested grafts. Summarized, the two major contributing factors are theorized to be harvesting techniques and vein trauma during harvesting.
With recognized disadvantages of open vessel harvesting including higher incidence of infection, longer incisions, greater potential for poor healing, and longer length of hospital stay, reducing the failure rate of vein grafts harvested endoscopically is of utmost importance.
It is our hypothesis that modification of existing harvesting techniques can improve vein graft patency in endoscopic vein graft harvesting so that patency rates comparable to open vessel harvesting can be obtained.
In this prospective, multi-center non-randomized, observational study, 100 patients will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone coronary artery bypass graft (CABG) procedures with endoscopic vein graft harvesting using best harvesting practices. As a part of routine postoperative care, patients will be prescribed dual-antiplatelet therapy of aspirin and clopidogrel. Compliance with 3 months of dual-antiplatelet therapy will be monitored.
Vein graft patency will be evaluated:
- Intra-operatively by transit time graft flow measurements.
- Post-operative Day 30 through Cardiac CT Angiography.
- Post-operative Month 12 through Cardiac CT Angiography.
- Conditions
- Coronary Artery Disease
- Keywords
- vein grafts, coronary bypass, endoscopic harvest, endoscopic vein harvest
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CABG w/saphenous vein grafts harvested using endoscopy | Those who have CABG surgery with saphenous vein grafts harvested using endoscopic techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved vein graft patency
To demonstrate improved vein graft patency at 12 months for endoscopically harvested saphenous vein grafts by using modifications to existing vein harvest techniques in vein handling during harvest.
Measured: Baseline and 12 months
Secondary outcomes (1)
Vein graft failure
- Assess the 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 postoperative day 30 as evaluated by Coronary CT angiography
- Incidence of vein graft failure at postoperative Month 12 as evaluated by Coronary CT angiography
- Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:
- Harvested vessel (greater versus lesser saphenous vein)
- Vein graft destinations
- Vein graft quality
Measured: Baseline, 30 days, 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 posted28 Feb 2012 (estimated)
- Study startOct 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Maquet Cardiovascular
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540422
- Sponsor's protocol ID
- 009-177
- Status last verified
- Mar 2015
- First submitted
- 23 Feb 2012
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bolotin G, Kypson AP, Nifong LW, Chitwood WR Jr. A technique for evaluating competitive flow for intraoperative decision making in coronary artery surgery. Ann Thorac Surg. 2003 Dec;76(6):2118-20. doi: 10.1016/s0003-4975(03)00652-0.
PubMed 14667667Lopes RD, Hafley GE, Allen KB, Ferguson TB, Peterson ED, Harrington RA, Mehta RH, Gibson CM, Mack MJ, Kouchoukos NT, Califf RM, Alexander JH. Endoscopic versus open vein-graft harvesting in coronary-artery bypass surgery. N Engl J Med. 2009 Jul 16;361(3):235-44. doi: 10.1056/NEJMoa0900708.
PubMed 19605828Burris N, Schwartz K, Tang CM, Jafri MS, Schmitt J, Kwon MH, Toshinaga O, Gu J, Brown J, Brown E, Pierson R 3rd, Poston R. Catheter-based infrared light scanner as a tool to assess conduit quality in coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2007 Feb;133(2):419-27. doi: 10.1016/j.jtcvs.2006.09.056. Epub 2006 Dec 29.
PubMed 17258576Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.
PubMed 19228612
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTION Trial: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
- ClinicalTrials.gov ID
- NCT01540422
- Acronym / sponsor ID
- 009-177
- Conditions
- Coronary Artery Disease
- Keywords
- vein grafts, coronary bypass, endoscopic harvest, endoscopic vein harvest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Maquet Cardiovascular
- Study start
- Oct 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Feb 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.
The purpose of this study is to demonstrate improved vein graft patency rates at 12 months for endoscopically harvested saphenous vein grafts. The study will evaluate use modifications to existing techniques in vein graft handling during harvests. A secondary aim is to develop a standardized approach for harvesting, handling, and preparing vein grafts in the endoscopic approach.
Detailed description
Available data supports two facts: 1) Saphenous vein graft failure rates may be as high as 47% per patient at one year post coronary artery bypass grafting, and 2) Endoscopic vein-graft harvesting is independently associated with vein-graft failure and adverse clinical outcomes.
Multiple factors may contribute to the lower long term patency rates of endoscopically harvested grafts. Summarized, the two major contributing factors are theorized to be harvesting techniques and vein trauma during harvesting.
With recognized disadvantages of open vessel harvesting including higher incidence of infection, longer incisions, greater potential for poor healing, and longer length of hospital stay, reducing the failure rate of vein grafts harvested endoscopically is of utmost importance.
It is our hypothesis that modification of existing harvesting techniques can improve vein graft patency in endoscopic vein graft harvesting so that patency rates comparable to open vessel harvesting can be obtained.
In this prospective, multi-center non-randomized, observational study, 100 patients will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone coronary artery bypass graft (CABG) procedures with endoscopic vein graft harvesting using best harvesting practices. As a part of routine postoperative care, patients will be prescribed dual-antiplatelet therapy of aspirin and clopidogrel. Compliance with 3 months of dual-antiplatelet therapy will be monitored.
Vein graft patency will be evaluated:
- Intra-operatively by transit time graft flow measurements.
- Post-operative Day 30 through Cardiac CT Angiography.
- Post-operative Month 12 through Cardiac CT Angiography.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABG w/saphenous vein grafts harvested using endoscopy | – | –Those who have CABG surgery with saphenous vein grafts harvested using endoscopic techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital facility
Key inclusion criteria (5 listed)
- Males and females at least 18 years of age and able to sign consent
- Undergoing CABG surgery
- Eligible for endoscopic saphenous vein harvesting
- A minimum of two non-sequential vein grafts will be performed
- Subject willing to comply with the requirements of the 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
Improved vein graft patency
Time frame: Baseline and 12 months
To demonstrate improved vein graft patency at 12 months for endoscopically harvested saphenous vein grafts by using modifications to existing vein harvest techniques in vein handling during harvest.
1 secondary outcome
Vein graft failure
Time frame: Baseline, 30 days, 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 17 Mar 2015.
- Background: PubMed 14667667Bolotin G, Kypson AP, Nifong LW, Chitwood WR Jr. A technique for evaluating competitive flow for intraoperative decision making in coronary artery surgery. Ann Thorac Surg. 2003 Dec;76(6):2118-20. doi: 10.1016/s0003-4975(03)00652-0.
- Results publication: PubMed 19605828Lopes RD, Hafley GE, Allen KB, Ferguson TB, Peterson ED, Harrington RA, Mehta RH, Gibson CM, Mack MJ, Kouchoukos NT, Califf RM, Alexander JH. Endoscopic versus open vein-graft harvesting in coronary-artery bypass surgery. N Engl J Med. 2009 Jul 16;361(3):235-44. doi: 10.1056/NEJMoa0900708.
- Results publication: PubMed 17258576Burris N, Schwartz K, Tang CM, Jafri MS, Schmitt J, Kwon MH, Toshinaga O, Gu J, Brown J, Brown E, Pierson R 3rd, Poston R. Catheter-based infrared light scanner as a tool to assess conduit quality in coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2007 Feb;133(2):419-27. doi: 10.1016/j.jtcvs.2006.09.056. Epub 2006 Dec 29.
- Results publication: PubMed 19228612Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Baylor Research 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 5 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 17 Mar 2015. 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?
Improved vein graft patency (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01540422, which also lists 4 linked publications.
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 17 Mar 2015.