|- candidate number||8556|
|- NTR Number||NTR2567|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-okt-2010|
|- Secondary IDs||M10-1053 METC Catharina Ziekenhuis|
|- Public Title||CORLINK LONG-TERM FOLLOW UP.|
|- Scientific Title||CORLINK LONG-TERM FOLLOW UP.|
|- ACRONYM||CORLINK LONG-TERM FOLLOW UP|
|- hypothesis||Within long term follow up hand sewn anastomoses in coronary artery bypass grafting are more patent than corlink facilitated anastomoses.|
|- Healt Condition(s) or Problem(s) studied||Angina Pectoris, Coronary Artery Bypass Grafting (CABG), Sutureless anastomoses, Coronary artery disease|
|- Inclusion criteria||Participation Corlink Trial (METC #M00/1616 & nr. METC#M03/1359).|
|- Exclusion criteria||1. Atriumfibrillation;|
2. Severe renal insufficiency;
3. Coronary angiogram (diagnostic/intervention) in past year;
4. Cardiac CT scan in past year;
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-okt-2010|
|- planned closingdate||1-apr-2011|
|- Target number of participants||30|
|- Interventions||Participation in Corlink Trial.|
|- Primary outcome||Long term patency of coronary artery bypass grafts.|
|- Secondary outcome||N/A|
|- Timepoints||256 Cardiac CT scan.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD N.J. Verberkmoes|
|- CONTACT for SCIENTIFIC QUERIES||MD N.J. Verberkmoes|
|- Sponsor/Initiator ||Catharina Hospital Eindhoven|
(Source(s) of Monetary or Material Support)
|Catharina Hospital Eindhoven|
|- Brief summary||From 2001 to 2004, the research department of cardiothoracic surgery participated in the Multi-center trial Corlink. The study took place in our center and in the Ziekenhuis in Breda. In short, this involved an experimental trial of the applicability of adhesion-free connections in the coronary artery surgery. One of the most important primary endpoints of this study was the so-called short-term patency of coronary bypass grafts (patency = good blood flow in the diversion). The study found that using a coronary angiogram. For more details, I refer you to the Protocol to METC METC # # No M00/1616 & M03/1359. At the time the study was completed successfully.
However, as stated above, patients participated in an experimental trial. Because we always strive for quality care, we believe that the participants in this study are entitled to a long-term control.
Using the 256 multi-slice computed tomography we study long term patency.
The released data we use in the future regarding the use of the mechanical connectors in coronary artery surgery. To date, the long-term patency of these compounds in the coronary vascular assisted surgery has not been described in international literature.
Countries of recruitment > Netherlands.
|- Main changes (audit trail)|
|- RECORD||15-okt-2010 - 24-okt-2010|