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This clinical study has been developed to evaluate the clinical outcomes in patients undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a minimally invasive coronary bypass procedure that is done on a beating heart via a smaller chest incision, thus avoiding the invasiveness of the standard procedure.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive coronary artery bypass graft surgery | Procedure | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of procedure (day 1) |
| 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. | At time of procedure (day 1) |
| 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) | 6 months post-procedure |
| 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:
| During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation) |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Major Adverse Event Rate (Late) | Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major adverse events will include:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph McGinn, MD | Staten Island University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Staten Island University Hospital | Staten Island | New York | 10305 | United States | ||
| University of Ottawa Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24183338 | Derived | Ruel M, Shariff MA, Lapierre H, Goyal N, Dennie C, Sadel SM, Sohmer B, McGinn JT Jr. Results of the Minimally Invasive Coronary Artery Bypass Grafting Angiographic Patency Study. J Thorac Cardiovasc Surg. 2014 Jan;147(1):203-8. doi: 10.1016/j.jtcvs.2013.09.016. Epub 2013 Oct 30. |
| Label | URL |
|---|---|
| Medtronic, Inc. Corporate Website | View source |
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A total of 91 subjects were enrolled, with 89 subjects receiving the study treatment. The first subject was enrolled on December 30, 2009 and the last subject was enrolled on October 4, 2012. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Minimally Invasive Coronary Artery Bypass Grafting | 91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation |
| Ottawa |
| Ontario |
| K1Y4W7 |
| Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Completion Cohort | 91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of grafts | At time of procedure (day 1) | Grafts | Participants |
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| Primary | 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. | Posted | Number | percentage of subjects | At time of procedure (day 1) |
|
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| Primary | 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) | Posted | Number | percentage of grafts | 6 months post-procedure | Grafts | Participants |
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| Primary | 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:
| Posted | Number | 95% Confidence Interval | percentage of subjects | During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation) |
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| Secondary | Composite Major Adverse Event Rate (Late) | Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major adverse events will include:
| Posted | Number | percentage of subjects | After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation |
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Adverse events reported from treatment through 6-month follow-up.
Adverse events were classified as serious by the PI following ISO 14155 standards.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Procedure Cohort | 89 Subjects received study treatment | 14 | 89 | 46 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina | Cardiac disorders | Systematic Assessment |
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| Anemia and blood loss | Blood and lymphatic system disorders | Systematic Assessment |
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| Bleeding | Blood and lymphatic system disorders | Systematic Assessment | Bleeding (2), Bleeding/Oozing (1) |
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| Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Low Cardiac Index | Cardiac disorders | Systematic Assessment | Low cardiac index (2), low cardiac index and central venous pressure (1) |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Surgical Blood Loss | Surgical and medical procedures | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Subcutaneous Emphysema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Atelectasis and Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Lawman | Medtronic, Inc. | 763-514-9809 | kristin.j.lawman@medtronic.com |
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Grafts |
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