|- candidate number||14564|
|- NTR Number||NTR3914|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-mrt-2013|
|- Secondary IDs||190108 NJV|
|- Public Title||Coupler Study.|
|- Scientific Title||PATENCY OF THE GEM MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM™ IN CORONARY ARTERY BYPASS GRAFTING: A Pilot Study.|
|- ACRONYM||Coupler Study|
|- hypothesis||Use of the GEM microvascular anastomotic coupler is feasible in coronary artery bypass procedures with the extended radial artery technique and the coupler anastomoses is patent after 3 months.|
|- Healt Condition(s) or Problem(s) studied||Coronary Artery Bypass Grafting (CABG)|
|- Inclusion criteria||1. Able to give informed consent able to understand the intent and clinical meaning of the study as well as its implication;|
2. Patients between 18 years and 70 years old;
3. Willing and able to have follow-up visits and examinations;
4. Standard Euroscore < 2.
|- Exclusion criteria||1. Procedure is done as an emergency operation;|
2. Unable to meet study requirements, i.e. mobility challenge;
3. Participation in any other clinical trial;
5. Concomitant with heart valve surgery;
6. History of any cardiac surgery other than PTCA and stent placement;
7. History of IABP within the last 30 days;
8. History of atrial fibrillation;
9. Congestive heart failure or been classified NYHA Class IV in the last 30 days;
10. History of bleeding disorder or history of thromboembolic disease requiring anticoagulation therapy;
11. Hemodynamically unstable;
12. History of acute or chronic dialysis;
13. Creatinine level of > 200 mmol/ml or 2,3 mg/dL in the last 30 days;
14. Documented or suspected acute systemic infection;
15. Need for immunosuppressive therapy;
16. Cerebrovascular accident within the last 2 weeks;
17. Allergy or other contraindication for aspirin or other anticoagulant/antiplatelet therapy;
18. Allergy or other contraindication for Iomeron® contrast agent;
19. Allergy or other contraindication for metoprolol.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2013|
|- planned closingdate||1-sep-2013|
|- Target number of participants||20|
|- Interventions||Standard CABG procedure, with extended radial artery technique, with the radial-lita anastomoses facilitated with the GEM flow microvascular coupler.|
|- Primary outcome||1. Acute Patency: The presence of acute patency of the distal anastomoses as determined by flow measurements intraoperatively;|
2. Chronic Patency: The presence of patency of the end-to-end radial-lita anastomoses as determined by multislice CT - Scan at 3 months;
3. Incidence of device related Adverse Events.
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD N.J. Verberkmoes|
|- CONTACT for SCIENTIFIC QUERIES||MD N.J. Verberkmoes|
|- Sponsor/Initiator ||Catharina Hospital|
(Source(s) of Monetary or Material Support)
|Catharina Hospital Eindhoven, |
|- Brief summary||Rationale: |
Coronary Artery ByPass Grafting (CABG) procedures are typically employed to achieve revascularization of the heart. Different conduits can be used for bypass grafting.
In the last two decades, the radial artery (RA) has emerged as a major alternative arterial conduit in preference to saphenous vein grafts or when traditional grafts are unsuitable or unavailable in coronary artery bypass grafting (CABG). However, to optimize the use of RA as a coronary bypass conduit, several technical considerations have been emphasized.
One technique, as performed in our hospital, is the use of extended radial artery conduit for revascularization, with the use of both the left internal thoracic artery (LITA) and the RA, with a hand sewn end-to-end anastomoses. Though disadvantages of conventional suturing techniques for end-to-end anastomoses are; intraluminal suture material in the anastomoses, time consuming, difficulties in vessel size mismatch corrections and surgeon dependent quality of the anastomotic configuration. A well known and well described anastomotic device, which is used extensively in plastic surgery (and standard practice for some plastic surgical procedures in our hospital) and neurosurgery to facilitate anastomoses; is the GEM Microvascular Anastomotic COUPLER System. The system is specifically designed for use in the anastomosis of veins and arteries in microsurgical procedures. The GEM COUPLER is intended for use with veins and arteries having an outside diameter no smaller than 0.8mm and no larger than 4.3mm and a wall thickness of 0.5mm or less.
The purpose of this study is to demonstrate patency of the GEM COUPLER system to facilitate the LITA-RA end-to-end anastomosis in CABG procedures.
Patients planned to undergo a CABG procedure and agree to participate in the study (signed informed consent) will be included for the study. The surgery will be a routine CABG procedure, performed with the routine Extended Radial Artery Conduit Technique and extension of the radial artery with GEM COUPLER System, and according to the standard hospital practice;
Post procedure , the patients will be treated according to the hospital standard practice. The patients will be asked to return to a follow up visits at 3 months post hospital discharge, at which time an ECG will be performed, and data on blood pressure, anginal status and anticoagulant medications will be collected. At the 3-month follow-up visit, also a Multislice Computed Tomography (MS – CT scan) will be performed and patency information will be recorded on the study vessel.
|- Main changes (audit trail)|
|- RECORD||21-mrt-2013 - 29-sep-2013|