CrossBoss and Hybrid Registry on Coronary Chronic Total Occlusions

Chronic Total Occlusion of Coronary Artery Clinical Trial

— RECHARGE  

Official title:

REgistry of CrossBoss and Hybrid Procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075372
• Other study ID #: 13/094L
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: August 10, 2017
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: August 2017
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1177
• Est. completion date: January 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel	Limburg
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg
Belgium	Hasselt University	Hasselt	Limburg
France	Groupe Hospitalier Mutualiste (GHM)	Grenoble
France	Clinique de Marignane	Marignane
France	Nouvelles Cliniques Nantaises (NCN)	Nantes
France	Hôpital Nord - CHU de St Etienne	Saint-Priest en Jarez
Netherlands	Onze-Lieve-Vrouwe Gasthuis (OLVG)	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Erasmus MC	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht (UMCU)	Utrecht
United Kingdom	Basildon University Hospital	Basildon
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	University Hospital of Bristol	Bristol
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Golden Jubilee Hospital	Glasgow
United Kingdom	Kings College London	London
United Kingdom	London Chest Hospital	London
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Nottingham City Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome of CTO PCI procedure	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.	after 3 hours
Secondary	Outcome of PCI procedures in which CrossBoss™ technology is used (as a stand alone device)	Outcome (success/failure) of PCI procedures in which CrossBoss™ technology is used (as a stand alone device).	after 3 hours
Secondary	Outcome of PCI procedures in which CrossBoss™ technology is used (combined with other techniques).	Outcome (success/failure) of PCI procedures in which CrossBoss™ technology is used (combined with other techniques)	after 3 hours
Secondary	Complications	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.	up to month 1
Secondary	Clinical status after PCI procedure	Record medical drug prescription (after CTO PCI) and clinical status during in-hospital stay and during follow-up (1 month).	up to month 1