CrossBoss and Hybrid Registry on Coronary Chronic Total Occlusions

NCT ID: NCT02075372

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1177 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Chronic Total Occlusion of Coronary Artery

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Data registration

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Jo Dens

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jo Dens, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Joren Maeremans, MSc

Role: STUDY_CHAIR

Ziekenhuis Oost-Limburg

Locations

UZ Brussel

Brussels, Limburg, Belgium

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Hasselt University

Hasselt, Limburg, Belgium

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, , France

Onze-Lieve-Vrouwe Gasthuis (OLVG)

Amsterdam, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Universitair Medisch Centrum Utrecht (UMCU)

Utrecht, , Netherlands

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

London Chest Hospital

London, , United Kingdom

Kings College London

London, , United Kingdom

Freeman Hospital

Newcastle, , United Kingdom

Nottingham City Hospital

Nottingham, , United Kingdom

Countries

Belgium; France; Netherlands; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 28625964 (View on PubMed)

Other Identifiers

13/094L

Identifier Type: -

Identifier Source: org_study_id