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CrossBoss and Hybrid Registry on Coronary Chronic Total Occlusions (RECHARGE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02075372
First Posted: March 3, 2014
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
prof. dr. Jo Dens, Hasselt University
  Purpose

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 Intervention
Chronic Total Occlusion of Coronary Artery Other: Data registration

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: REgistry of CrossBoss and Hybrid Procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom

Further study details as provided by prof. dr. Jo Dens, Hasselt University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 1177
Study Start Date: January 2014
Study Completion Date: January 2017
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Belgium
UZ Brussel
Brussel, Limburg, Belgium, 1090
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
Hasselt University
Hasselt, Limburg, Belgium, 3500
France
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
Netherlands
Onze-Lieve-Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands, 1091 AC
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623
Erasmus MC
Rotterdam, Netherlands, 3015 CE
Universitair Medisch Centrum Utrecht (UMCU)
Utrecht, Netherlands, 3584 CX
United Kingdom
Basildon University Hospital
Basildon, United Kingdom
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
University Hospital of Bristol
Bristol, United Kingdom, BS1 2LY
Ninewells Hospital
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
Freeman Hospital
Newcastle, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Sponsors and Collaborators
Hasselt University
Investigators
Principal Investigator: Jo Dens, prof. dr. Ziekenhuis Oost-Limburg
Study Chair: Joren Maeremans, MSc Ziekenhuis Oost-Limburg
  More Information

Responsible Party: prof. dr. Jo Dens, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02075372     History of Changes
Other Study ID Numbers: 13/094L
First Submitted: December 16, 2013
First Posted: March 3, 2014
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by prof. dr. Jo Dens, Hasselt University:
Chronic Total Occlusion of Coronary Artery
Percutaneous Coronary Intervention
Hybrid
Angioplasty