Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery

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 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

2 sites in 2 countries.

About this study

Conditions

Arteriosclerosis of Coronary Artery Bypass Graft

Being tested

Minimally invasive coronary artery bypass graft surgery

Keywords

Minimally invasive coronary surgery, Coronary artery bypass grafting, MICS CABG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Minimally invasive coronary artery bypass graft surgeryProcedure or surgery

  Also called MICS CABG

  The MICS CABG procedure can bridge the gap between percutaneous coronary intervention (PCI) and standard sternotomy. The key components are direct vision, creating anastomoses with traditional instruments and proximal aortic location.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Technical Success (Graft Patency) in a MICS Approach

   For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.

   Measured: At time of procedure (day 1)

2. Procedural Success in a MICS Approach

   A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.

   Measured: At time of procedure (day 1)

3. Patency of the Index Graft at 6 Months

   For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results.

   The FitzGibbon Scoring system is as follows:

   A:Excellent graft with unimpaired runoff (< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to <50% of the grafted coronary artery.

   O:Occluded (100% stenosed)

   Measured: 6 months post-procedure

4. Composite Major Adverse Event Rate (Early)

   During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include:

   • Major hemorrhage/bleeding requiring surgical intervention
   • Aortic complications
   • Graft vessel revision (GVR)
   • Transient ischemic attacks (TIA)
   • Cerebrovascular accidents (CVA)/stroke
   • Myocardial infarction (MI)
   • Death

   Measured: During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 Apr 2011 (estimated)
2. Study startDec 2009
3. Primary completionApr 2013
4. Study completionApr 2013

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Arteriosclerosis of Coronary Artery Bypass GraftStudies of the same condition, open and under way.
• More trials run by Medtronic CardiovascularThe 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.