|- candidate number||3839|
|- NTR Number||NTR1409|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-aug-2008|
|- Secondary IDs||NJV_130679 |
|- Public Title||Cardica C Port xA Anastomotic System|
|- Scientific Title||Cardica C Port xA Anastomotic System|
|- ACRONYM||Cardica C - Port xA|
|- hypothesis||To demonstrate equivalency of the Cardica C - Port xA anastomosis compared to hand sutured anastomoses in patients undergoing CABG with respect to 12 months patency at distal anastomosis site.|
|- Healt Condition(s) or Problem(s) studied||Angina Pectoris, Coronary Artery Bypass Grafting (CABG), Coronary artery disease, Sutureless anastomoses|
|- Inclusion criteria||1. Abe to give informed consent able to understand the intent and clinical meaning of the study as well as its implication. |
2. Patients 18 years old or older.
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. Not a standard CABG operation or is 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. Congestive heart failure or been classified NYHA Class IV in the last 30 days.
9. History of bleeding disorder or history of thromboembolic disease requiring anticoagulation therapy.
10. Hemodynamically unstable.
11. History of acute or chronic dialysis.
12. Creatinine level of > 200 mmol/ml or 2,3 mg/dL in the last 30 days.
13. Documented or suspected acute systemic infection.
14. Need for immunosuppressive therapy.
15. Cerebrovascular accident within the last 2 weeks.
16. Allergy or other contraindication for aspirin or other anticoagulant/antiplatelet therapy
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2008|
|- planned closingdate||1-aug-2010|
|- Target number of participants||78|
|- Interventions||Coronary Bypass Surgery|
|- Primary outcome||a. Acute: The presence of acute patency of the distal anastomoses as determined by flow measurements intraoperatively.|
b. Chronic: The presence of patency of the distal anastomoses as determined by multislice CT - Scan at 12 months.
c. Incidence of device related Adverse Events
|- Secondary outcome||a. Time required for system loading and for the distal anastomosis to be completed.|
b. User friendliness of the system
c. Abbreviated ischemic time using Cardica C - Port xA
|- Timepoints||1. Perioperative / In Hospital|
2. 6 month follow-up (clinical)
3. 12 month follow-up (clinical and CT-scan)
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. Berreklouw|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Berreklouw|
|- Sponsor/Initiator ||Catharina Hospital Eindhoven|
(Source(s) of Monetary or Material Support)
|LST Europe B.V.|
|- Brief summary|| Coronary Artery Disease (CAD) is the leading cause of death in our society. Either Percutaneous Transluminal Coronary Angioplasty (PTCA), with or without stenting, or Coronary Artery ByPass Grafting (CABG) procedures are typically employed to achieve revascularization of the heart. The Cardica C - Port xA is intended for use in CABG procedures for creating a rapid sutureless end to side directional distal anastomosis between a grafted vessel (vein or artery) and the coronary artery. The Cardica C - Port xA has three possible advantages compared to the standard suturing technique: The Cardica C - Port xA may provide a method for standardizing the anastomosis procedure. Usage of the Cardica C - Port xA may shorten the actual suturing period of 10-25 minutes and the period of myocardial ischemia associated with local occlusion of a coronary vessel in OPCAB procedures. For OPCAB cases, shortening the time needed for graft connection will reduce the period of hemodynamic instability frequently associated with heart displacement needed for back wall vessels exposure. Finally, the anastomosis created with a C-Port xA is compliant as opposed to an anastomosis created using the standard running suturing technique, where the anastomosis is non-compliant and is restricted in its ability to expand with increasing blood flow requirements. |
|- Main changes (audit trail)|
|- RECORD||17-aug-2008 - 5-aug-2012|