CrossBoss and Hybrid Registry on Coronary Chronic Total Occlusions (RECHARGE)
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|ClinicalTrials.gov Identifier: NCT02075372|
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : August 11, 2017
The successful re-opening of a blocked coronary artery 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), a 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 or revascularize a blockage in one of the blood vessels of the heart. This type of blockages are chronic total occlusions (CTO). CTOs have certain characteristics which impede the revascularization of the blood vessel.
Nevertheless, remarkable progress has been achieved over the past few years in the area of CTO revascularization or CTO PCI. A large range of CTO dedicated materials, such as guidewires, guiding catheters, devices, balloons and stents, as well as different techniques have been developed. However, at present, reluctance to open CTOs still exists, due to the indications and outcomes of percutaneous revascularization as well as the technical difficulties which commonly arise during these interventional 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 materials (e.g. CrossBoss™ catheter; Bridgepoint Medical, Inc.) and techniques, currently already available. The main purpose of this study is to evaluate the efficacy and efficiency of this hybrid algorithm as well as validating the efficacy of one of the materials (CrossBoss™ catheter), used in this algorithm. To be able to do this, data concerning the patients' demographics, CTO characteristics, procedure and outcome will be collected in the form of a registry. This registry will be performed in several European centra (Belgium, the Netherlands, United Kingdom, France). Since the study will only collect data and no intervention is performed, this will be an observational study. At regular time points, the data will be checked for errors or inconsistencies. To do this, site visits will be performed at pre-defined times.
|Condition or disease||Intervention/treatment|
|Chronic Total Occlusion of Coronary Artery||Other: Data registration|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1177 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||REgistry of CrossBoss and Hybrid Procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom|
|Study Start Date :||January 2014|
|Primary Completion Date :||October 2015|
|Study Completion Date :||January 2017|
Data registration of CTO-PCI patients
Patients diagnosed with the presence of one or more chronic total occlusions (CTOs) and who will receive treatment via percutaneous coronary intervention (PCI), which is standard medical practice for these types of lesions. This study will register data on the patients' demographics, CTO characteristics, procedure and outcome. This will be done in the form of a registry.
Other: Data registration
Patients diagnosed with the presence of one or more chronic total occlusions (CTOs) and who will receive treatment via percutaneous coronary intervention (PCI), which is standard medical practice for these types of lesions. This study will collect data on the patients' demographics, CTO characteristics, procedure and outcome. This will be done in the form of a registry
- Outcome of CTO PCI procedure [ Time Frame: after 3 hours ]Description: Success percentage of the hybrid algorithm and of those procedures in which CrossBoss™ and Stingray™ technologies are used (as a stand alone device or combined with other techniques) in CTO lesions according to the Japanese scoring system (J-CTO). Success is defined as successful revascularization, resulting in TIMI flow 3.
- Outcome of PCI procedures in which CrossBoss™ technology is used (as a stand alone device) [ Time Frame: after 3 hours ]Outcome (success/failure) of PCI procedures in which CrossBoss™ technology is used (as a stand alone device).
- Outcome of PCI procedures in which CrossBoss™ technology is used (combined with other techniques). [ Time Frame: after 3 hours ]Outcome (success/failure) of PCI procedures in which CrossBoss™ technology is used (combined with other techniques)
- Complications [ Time Frame: up to month 1 ]Complications (either CrossBoss™/Stingray™ related or not): Major Adverse Cardiac Events (MACE) during in-hospital stay (approximately 1-2 days) and at follow-up (first month after CTO PCI). MACE is common endpoint for death, Q-wave myocardial infarction (MI) (according to ESC guidelines), non Q-wave MI (according to ESC guidelines) and target vessel revascularization. Other complications include target vessel failure (i.e. applies when target vessel is occluded at follow-up (first month after CTO PCI) but no revascularization has been considered), tamponade, perforation, bleeding requiring transfusion/surgery, peri-procedural infarction ((N-)STEMI) (according to ESC guidelines) and loss of side-branches.
- Clinical status after PCI procedure [ Time Frame: up to month 1 ]Record medical drug prescription (after CTO PCI) and clinical status during in-hospital stay and during follow-up (1 month).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075372
|Brussel, Limburg, Belgium, 1090|
|Genk, Limburg, Belgium, 3600|
|Hasselt, Limburg, Belgium, 3500|
|Groupe Hospitalier Mutualiste (GHM)|
|Grenoble, France, 38000|
|Clinique de Marignane|
|Marignane, France, 13700|
|Nouvelles Cliniques Nantaises (NCN)|
|Nantes, France, 44277|
|Hôpital Nord - CHU de St Etienne|
|Saint-Priest en Jarez, France, 42270|
|Onze-Lieve-Vrouwe Gasthuis (OLVG)|
|Amsterdam, Netherlands, 1091 AC|
|Eindhoven, Netherlands, 5623|
|Rotterdam, Netherlands, 3015 CE|
|Universitair Medisch Centrum Utrecht (UMCU)|
|Utrecht, Netherlands, 3584 CX|
|Basildon University Hospital|
|Basildon, United Kingdom|
|Belfast City Hospital|
|Belfast, United Kingdom, BT9 7AB|
|University Hospital of Bristol|
|Bristol, United Kingdom, BS1 2LY|
|Dundee, United Kingdom|
|Royal Infirmary of Edinburgh|
|Edinburgh, United Kingdom, EH16 4SA|
|Golden Jubilee Hospital|
|Glasgow, United Kingdom|
|London Chest Hospital|
|London, United Kingdom, E2 9JX|
|Kings College London|
|London, United Kingdom|
|Newcastle, United Kingdom|
|Nottingham City Hospital|
|Nottingham, United Kingdom|
|Principal Investigator:||Jo Dens, prof. dr.||Ziekenhuis Oost-Limburg|
|Study Chair:||Joren Maeremans, MSc||Ziekenhuis Oost-Limburg|