CrossBoss and Hybrid Registry on Coronary Chronic Total Occlusions

NCT02075372 | Completed

• 1 other identifier: 13/094L
• Study Type: observational
• Target: 1,177
• Locations: 4 countries
• Sites: 21

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

Keywords

Chronic Total Occlusion of Coronary Artery; Percutaneous Coronary Intervention; Hybrid; Angioplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Outcome of PCI procedures in which CrossBoss™ technology is used (as a stand alone device)

  after 3 hours

• Outcome of PCI procedures in which CrossBoss™ technology is used (combined with other techniques).

  after 3 hours

• Complications

  up to month 1

• Clinical status after PCI procedure

  up to month 1

Study Arms (1)

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

Interventions

Data registration 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

Data registration of CTO-PCI patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (21)

UZ Brussel

Brussels, Limburg, 1090, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Hasselt University

Hasselt, Limburg, 3500, Belgium

Location

Groupe Hospitalier Mutualiste (GHM)

Grenoble, 38000, France

Location

Clinique de Marignane

Marignane, 13700, France

Location

Nouvelles Cliniques Nantaises (NCN)

Nantes, 44277, France

Location

Hôpital Nord - CHU de St Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Onze-Lieve-Vrouwe Gasthuis (OLVG)

Amsterdam, 1091 AC, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

Universitair Medisch Centrum Utrecht (UMCU)

Utrecht, 3584 CX, Netherlands

Location

Basildon University Hospital

Basildon, United Kingdom

Location

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

University Hospital of Bristol

Bristol, BS1 2LY, United Kingdom

Location

Ninewells Hospital

Dundee, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Golden Jubilee Hospital

Glasgow, United Kingdom

Location

London Chest Hospital

London, E2 9JX, United Kingdom

Location

Kings College London

London, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Nottingham City Hospital

Nottingham, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28625964 DERIVED

Study Officials

• Jo Dens, prof. dr.

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

• Joren Maeremans, MSc

  Ziekenhuis Oost-Limburg

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: March 3, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2017
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

GB (10); BE (3); NL (4); FR (4)