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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Other: Data registration

• Study Type: Observational
• Enrollment (Actual): 1177

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Brussel, Limburg, Belgium, 1090
      • UZ Brussel
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Hasselt University
• France
  • Grenoble, France, 38000
    • Groupe Hospitalier Mutualiste (GHM)
  • Marignane, France, 13700
    • Clinique de Marignane
  • Nantes, France, 44277
    • Nouvelles Cliniques Nantaises (NCN)
  • Saint-Priest en Jarez, France, 42270
    • Hôpital Nord - CHU de St Etienne
• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • Onze-Lieve-Vrouwe Gasthuis (OLVG)
  • Eindhoven, Netherlands, 5623
    • Catharina Ziekenhuis
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus MC
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht (UMCU)
• United Kingdom
  • Basildon, United Kingdom
    • Basildon University Hospital
  • Belfast, United Kingdom, BT9 7AB
    • Belfast City Hospital
  • Bristol, United Kingdom, BS1 2LY
    • University Hospital of Bristol
  • Dundee, United Kingdom
    • Ninewells Hospital
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh
  • Glasgow, United Kingdom
    • Golden Jubilee Hospital
  • London, United Kingdom, E2 9JX
    • London Chest Hospital
  • London, United Kingdom
    • Kings College London
  • Newcastle, United Kingdom
    • Freeman Hospital
  • Nottingham, United Kingdom
    • Nottingham City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Jo Dens, prof. dr., Ziekenhuis Oost-Limburg; Study Chair: Joren Maeremans, MSc, Ziekenhuis Oost-Limburg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (ESTIMATE): March 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Angioplasty; Hybrid; Chronic Total Occlusion of Coronary Artery
• Other Study ID Numbers: 13/094L

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED