RECHARGE version 1
Research type
Research Study
Full title
Registry of CrossBoss and Hybrid CTO PCI procedures in France, the Netherlands, Belgium and United Kingdom
IRAS ID
141504
Contact name
Simon Walsh
Contact email
Sponsor organisation
Universiteit Hasselt
Clinicaltrials.gov Identifier
ClinicalTrials.gov Identifier:, NCT02075372
Research summary
The successful re-opening of a blocked vessel of the heart has a beneficial effect on the further clinical course (e.g. improvement of clinical symptoms, improved quality of life, increased heart function, etc.). However, some types of blockages are more difficult to open by means of percutaneous coronary intervention (PCI), an interventional procedure which is commonly used for these kind of problems. This procedure makes use of a technique in which special wires, balloons, stents (metal or polymeric tube-like structures) and devices are utilized to re-open a blockage in one of the blood vessels of the heart. These types of blockages are chronic total occlusions (CTO). CTOs have certain characteristics which impede the re-opening of the blood vessel.
Although remarkable progress has already been achieved in the field of CTO PCI over the last few years (CTO dedicated materials and techniques, e.g. guidewires, balloons, etc.), reluctance to open CTOs still exists due to the technical difficulties which commonly arise during these procedures. The presence of these difficulties results in suboptimal success rates worldwide (~70-80%), despite these many innovations.
To increase these success rates and to make sure more interventional cardiologists will treat CTOs, a hybrid treatment algorithm has been developed with the techniques and materials (e.g. CrossBoss™ catheter, Stingray™; Bridgepoint Medical, Inc.), currently already available. Based on several characteristics of the CTO, a certain strategy is chosen, based on the algorithm. In the RECHARGE study, we want to evaluate the efficacy and efficiency of this hybrid algorithm as well as validate the efficacy of the CrossBoss™ system, used in this algorithm. To do this, data concerning the patients’ demographics, CTO characteristics, procedure and outcome will be collected in the form of a registry.
This prospective, non-randomized registry will be performed in several European centers (Belgium, the Netherlands, United Kingdom and France).
REC name
North of Scotland Research Ethics Committee 2
REC reference
14/NS/1028
Date of REC Opinion
28 Aug 2014
REC opinion
Further Information Favourable Opinion