Clinical trial NCT01697176: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Cardiopulmonary Research Science and Technology Institute
Sponsor class: OTHER
Collaborators: name: Maquet Cardiovascular
First posted: 2012-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Isolated CABG

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
timeFrame: 12 months
Secondary outcomes:
measure: OPTION
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: CRSTI/Medical City Dallas
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
Study officials:
affiliation: The Heart Hospital Baylor Plano
name: David Moore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiopulmonary Research Science and Technology Institute
name: Michael J Mack, MD
role: PRINCIPAL_INVESTIGATOR
References: