Clinical trial NCT02075372: CrossBoss and Hybrid Registry on Coronary Chronic Total Occlusions
Official title: REgistry of CrossBoss and Hybrid Procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Total Occlusion of Coronary Artery
Keywords: Chronic Total Occlusion of Coronary Artery
Percutaneous Coronary Intervention
Hybrid
Angioplasty
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 1177
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with the presence of one or more chronic total occlusions (CTOs) and who will receive treatment via percutaneous coronary intervention (PCI)

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subject shows the presence of at least one coronary chronic total occlusion (CTO), either with or without the presence of one or more other diseased coronary arteries. This CTO must be located in a native coronary artery and have a visually estimated stenosis of 100%, corresponding with Thrombolysis in Myocardial Infarction (TIMI) flow 0. Following the operators judgment, this occlusion is present for more then 3 months.
* Subject will be/is treated percutaneously for one or more CTOs via the hybrid techniques.
* Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed.
* Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after PCI procedure to assess any complications and clinical status).

Exclusion Criteria:

* The occlusion is considered to be less than 3 months present.
* Subject is treated via PCI without application of the hybrid algorithm and/or use of the CrossBoss™ and Stingray™ technology (Bridgepoint Medical, Inc.).
* Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
* Subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.

Primary outcomes:
measure: Outcome of CTO PCI procedure
timeFrame: after 3 hours
Secondary outcomes:
measure: Outcome of PCI procedures in which CrossBoss™ technology is used (as a stand alone device)
timeFrame: after 3 hours
measure: Outcome of PCI procedures in which CrossBoss™ technology is used (combined with other techniques).
timeFrame: after 3 hours
measure: Complications
timeFrame: up to month 1
measure: Clinical status after PCI procedure
timeFrame: up to month 1
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
state: Limburg
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste (GHM)
city: Marignane
country: France
facility: Clinique de Marignane
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises (NCN)
city: Saint-Priest en Jarez
country: France
facility: Hôpital Nord - CHU de St Etienne
city: Amsterdam
country: Netherlands
facility: Onze-Lieve-Vrouwe Gasthuis (OLVG)
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht (UMCU)
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Bristol
country: United Kingdom
facility: University Hospital of Bristol
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Glasgow
country: United Kingdom
facility: Golden Jubilee Hospital
city: London
country: United Kingdom
facility: London Chest Hospital
city: London
country: United Kingdom
facility: Kings College London
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Jo Dens, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziekenhuis Oost-Limburg
name: Joren Maeremans, MSc
role: STUDY_CHAIR
References:
citation: Maeremans J, Dens J, Spratt JC, Bagnall AJ, Stuijfzand W, Nap A, Agostoni P, Wilson W, Hanratty CG, Wilson S, Faurie B, Avran A, Bressollette E, Egred M, Knaapen P, Walsh S; RECHARGE Investigators. Antegrade Dissection and Reentry as Part of the Hybrid Chronic Total Occlusion Revascularization Strategy: A Subanalysis of the RECHARGE Registry (Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom). Circ Cardiovasc Interv. 2017 Jun;10(6):e004791. doi: 10.1161/CIRCINTERVENTIONS.116.004791.