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Chronic Total Occlusion of Coronary ArteryRECHARGENCT02075372

CrossBoss and Hybrid Registry on Coronary Chronic Total Occlusions

An observational study of Chronic Total Occlusion of Coronary Artery, run by Hasselt University at 21 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.). Read more about this study

Who is it for?
Any age
What is being tested?
Data registration
How many people
1,177 participants
Where
21 sitesin 4 countries
Study dates
Jan 2014to Jan 2017
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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)

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

21 sites in 4 countries.

21 sites in 4 countries

United Kingdom10 sites

  • Basildon University Hospital

    Basildon

  • Belfast City Hospital

    Belfast, BT9 7AB

  • University Hospital of Bristol

    Bristol, BS1 2LY

  • Ninewells Hospital

    Dundee

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • Golden Jubilee Hospital

    Glasgow

  • London Chest Hospital

    London, E2 9JX

  • Kings College London

    London

  • Freeman Hospital

    Newcastle

  • Nottingham City Hospital

    Nottingham

Other trials in United Kingdom

France4 sites

  • Groupe Hospitalier Mutualiste (GHM)

    Grenoble, 38000

  • Clinique de Marignane

    Marignane, 13700

  • Nouvelles Cliniques Nantaises (NCN)

    Nantes, 44277

  • Hôpital Nord - CHU de St Etienne

    Saint-Priest-en-Jarez, 42270

Other trials in France

Netherlands4 sites

  • Onze-Lieve-Vrouwe Gasthuis (OLVG)

    Amsterdam, 1091 AC

  • Catharina Ziekenhuis

    Eindhoven, 5623

  • Erasmus MC

    Rotterdam, 3015 CE

  • Universitair Medisch Centrum Utrecht (UMCU)

    Utrecht, 3584 CX

Other trials in Netherlands

Belgium3 sites

  • UZ Brussel

    Brussels, Limburg, 1090

  • Ziekenhuis Oost-Limburg

    Genk, Limburg, 3600

  • Hasselt University

    Hasselt, Limburg, 3500

Other trials in Belgium

About this study

Official title: 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.

Being tested
Data registration
Keywords
Chronic Total Occlusion of Coronary Artery, Percutaneous Coronary Intervention, Hybrid, Angioplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data registrationOther

    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

Study groups in NCT02075372
Study groupRoleWhat they receive
Data registration of CTO-PCI patientsPatients 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.
Receives: Other: Data registration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: after 3 hours

Secondary outcomes (4)

  1. 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).

    Measured: after 3 hours

  2. 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)

    Measured: after 3 hours

  3. 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.

    Measured: up to month 1

  4. 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).

    Measured: up to month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionOct 2015
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,177 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT02075372
Sponsor's protocol ID
13/094L
Acronym
RECHARGE
Status last verified
Aug 2017
First submitted
16 Dec 2013
Last updated
11 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 28625964

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Total Occlusion of Coronary Artery, run by Hasselt University at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United Kingdom, France, Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Outcome of CTO PCI procedure (time frame: after 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02075372, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.

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