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Coronary Artery DiseaseREMEDEE RegNCT01874002

Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent

An observational study of Coronary Artery Disease, run by Robbert J de Winter at 9 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with stenosis in one or more coronary artery are often treated with a percutaneous coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the vessel open over time. The Combo-Stent is a novel stent for use during percutaneous angioplasty. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Combo stent
Type of treatment
Medical device
How many people
1,000 participants
Where
9 sitesin 5 countries
Study dates
Jun 2013to Mar 2019
How long will I take part?
5 Years
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The registry population consists of consecutive patients in whom a treatment with a Combo stent in the setting of routine clinical care is attempted.

Who may be able to join

  • Consecutive patients eligible for Combo stent placement by percutaneous coronary intervention are included in the REMEDEE REGISTRY

Who cannot join

  • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  • Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
  • A life expectancy of <1 year
  • Explicit refusal of participation in the registry

Trial locations and contacts

9 sites in 5 countries.

9 sites in 5 countries

Netherlands5 sites

  • Academic Medical Center - University of Amsterdam

    Amsterdam, 1105AZ

  • Ter Gooi Ziekenhuizen

    Blaricum

  • Amphia Ziekenhuis

    Breda

  • Radboud UMC

    Nijmegen

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

Luxembourg1 site

  • Centre Hospitalier de Luxembourg

    Luxembourg

Other trials in Luxembourg

Spain1 site

  • Meixoeiro Hospital

    Vigo

Other trials in Spain

United Kingdom1 site

  • Craigavon Cardiac Centre

    Craigavon

Other trials in United Kingdom

About this study

Official title: Multicenter, Prospective, Clinical Outcomes After Deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio- Engineered Sirolimus Eluting Stent) Post Market Registry

Patients with stenosis in one or more coronary artery are often treated with a percutaneous coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the vessel open over time.

The Combo-Stent is a novel stent for use during percutaneous angioplasty. In short, the Combo stent combines a drug eluting technique and an endothelial cell attracting layer. The drug coating is designed to prevent re-narrowing of the stent. The endothelial cell attracting layer is designed to ensure rapid coverage of the stent struts with vascular wall cells.

The REMEDEE REGISTRY evaluates the long-term safety and performance of the Combo stent in routine clinical practice. In total 1000 patients will be registered and followed for five years.

Read the detailed description

Registry Investigated Device:

The OrbusNeich Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) consists of a 316L stainless steel alloy abluminally coated with a biocompatible, biodegradable polymer containing sirolimus. Covalently attached to this matrix is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets CD34+ cells in circulation. Endothelial progenitor cells (EPCs) are CD34+. The stent is supplied premounted on a 0.014" guide wire compatible low profile rapid exchange balloon catheter delivery system. The Combo Stent is Conformitée Européenne (CE) marked.

Registry Objectives:

The REMEDEE REGISTRY evaluates the long term safety and performance of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) in routine clinical practice. The primary objective of the registry is to evaluate the one year incidence of target lesion failure in consecutive patients undergoing percutaneous coronary intervention with (attempted) Combo stent placement.

Registry Design:

The REMEDEE REGISTRY is an international, prospective, multicenter, cohort post market registry with five years follow-up to evaluate outcomes in patients undergoing percutaneous coronary intervention with (attempted) Combo stent placement. The registry population consists of consecutive patients in whom a treatment with a Combo stent in the setting of routine clinical care is attempted.

This registry involves the collection of baseline demographic, clinical, and angiographic data, as well as follow-up data in consecutive patients in whom the Combo stent is used to treat (a) coronary lesion(s) in the setting of routine clinical care. Patients are registered in up to 10 European high volume PCI centers. A follow-up is scheduled at 30 days, 180 days,1 year, 2 years, 3 years, 4 years and 5 years post procedure. Follow-up is obtained at a planned regular visit to the out-patient clinic, or by telephone contact with the patient.

Quality control:

All data will be entered on-site in an electronic case report (eCRF) form according to Good Clinical Practice guidelines.

All sites will monitored regularly during the time of the registry. The monitor plan involves a hundred percent procedural information and event monitoring. During data monitoring, all source data will be assessed for accuracy, completeness, and representativeness of registry data by comparing the data to external data sources. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry are implemented in the (eCRF). A data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used, and normal ranges if relevant is part of the database and eCRF design. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management are in place. A detailed statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol is available. Missing data is accounted for in the design of the eCRF template, and will be handled according to the statistical plan.

Being tested
Combo stent
Keywords
Stents, Stent, Drug eluting, Drug eluting stent, Drug eluting stents, Endothelial progenitor cell, Endothelial progenitor cell capturing, Sirolimus, Sirolimus eluting, Percutaneous Coronary Intervention, PCI, Registry, Registries, Multi center, Multi centre
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Combo stentDevice

    Also called Abluminal Sirolimus Coated Bio-Engineered Stent, Combo Bio-Engineered Sirolimus Eluting Stent, SirolimusECS

    Percutaneous coronary intervention of patients with an indication for stent treatment with the COMBO stent, a stent with an endothelial progenitor cell attracting coating and abluminal sirolimus matrix. All consecutive patients treated with, or attempted treatment with, a COMBO stent are followed by telephone contact for 5 years.

Study groups in NCT01874002
Study groupRoleWhat they receive
Combo stentConsecutive patients in whom a treatment with a Combo stent in the setting of routine clinical care is attempted are entered into the registry.
Receives: Device: Combo stent

What is being measured

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

  1. Adjudicated Target Lesion Failure

    Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting).

    Measured: 1 year post-procedure

Secondary outcomes (31)

  1. Adjudicated Target Lesion Failure

    Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting).

    Measured: 30 days post-procedure

  2. Adjudicated Target Lesion Failure

    Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting).

    Measured: 180 days post procedure

  3. Individual components of target lesion failure (TLF)

    Individual components of target lesion failure (TLF):

    • Cardiac death
    • Non-fatal MI not clearly attributable to a non-target vessel
    • Target lesion revascularization (TLR)

    Measured: 1 year post-procedure

  4. Individual components of target lesion failure (TLF)

    Individual components of TLF:

    • Cardiac death
    • Non-fatal MI not clearly attributable to a non-target vessel
    • Target lesion revascularization (TLR)

    Measured: 30 days post-procedure

  5. Individual components of target lesion failure (TLF)

    Individual components of TLF:

    • Cardiac death
    • Non-fatal MI not clearly attributable to a non-target vessel
    • Target lesion revascularization (TLR)

    Measured: 180 days post-procedure

  6. Individual components of target lesion failure (TLF)

    Individual components of TLF:

    • Cardiac death
    • Non-fatal MI not clearly attributable to a non-target vessel
    • Target lesion revascularization (TLR)

    Measured: 1 year post-procedure

  7. Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

    Measured: 1 year post-procedure

  8. Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

    Measured: 30 days post-procedure

  9. Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

    Measured: 180 days post-procedure

  10. Each of the individual components of Major Adverse Cardiac Events(MACE)

    Each of the individual components of MACE:

    • All death
    • Any myocardial infarction
    • Any revascularization

    Measured: 1 year post-procedure

  11. Adjudicated stent thrombosis (definite/probable/possible)

    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

    Measured: 1 year post-procedure

  12. Adjudicated stent thrombosis (definite/probable/possible)

    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

    Measured: 30 days post-procedure

  13. Adjudicated stent thrombosis (definite/probable/possible)

    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

    Measured: 180 days post-procedure

  14. Device success

    Percentage of patients with a successful delivery and deployment of the Combo stent to the target lesion and a final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI flow, by visual estimation

    Measured: Procedural

  15. Procedure success

    Successful stent placement and no periprocedural complications.

    Measured: Procedural

  16. Adjudicated Target Lesion Failure

    Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting).

    Measured: 2 years post-procedure

  17. Adjudicated Target Lesion Failure

    Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting).

    Measured: 3 years post-procedure

  18. Adjudicated Target Lesion Failure

    Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting).

    Measured: 4 years post-procedure

  19. Adjudicated Target Lesion Failure

    Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting).

    Measured: 5 years post-procedure

  20. Individual components of target lesion failure (TLF)

    Individual components of target lesion failure (TLF):

    • Cardiac death
    • Non-fatal MI not clearly attributable to a non-target vessel
    • Target lesion revascularization (TLR)

    Measured: 2 years post-procedure

  21. Individual components of target lesion failure (TLF)

    Individual components of target lesion failure (TLF):

    • Cardiac death
    • Non-fatal MI not clearly attributable to a non-target vessel
    • Target lesion revascularization (TLR)

    Measured: 3 years post-procedure

  22. Individual components of target lesion failure (TLF)

    Individual components of target lesion failure (TLF):

    • Cardiac death
    • Non-fatal MI not clearly attributable to a non-target vessel
    • Target lesion revascularization (TLR)

    Measured: 4 years post-procedure

  23. Individual components of target lesion failure (TLF)

    Individual components of target lesion failure (TLF):

    • Cardiac death
    • Non-fatal MI not clearly attributable to a non-target vessel
    • Target lesion revascularization (TLR)

    Measured: 5 years post-procedure

  24. Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

    Measured: 2 years post-procedure

  25. Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

    Measured: 3 years post-procedure

  26. Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

    Measured: 4 years post-procedure

  27. Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

    Measured: 5 years post-procedure

  28. Adjudicated stent thrombosis (definite/probable/possible)

    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

    Measured: 2 years post-procedure

  29. Adjudicated stent thrombosis (definite/probable/possible)

    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

    Measured: 3 years post-procedure

  30. Adjudicated stent thrombosis (definite/probable/possible)

    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

    Measured: 4 years post-procedure

  31. Adjudicated stent thrombosis (definite/probable/possible)

    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

    Measured: 5 years post-procedure

Timeline

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

  1. First posted10 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionMar 2015
  4. Study completionMar 2019 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT01874002
Sponsor's protocol ID
W12_186
Other IDs
Version 2.0
Acronym
REMEDEE Reg
Status last verified
Dec 2015
First submitted
6 Jun 2013
Last updated
30 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Granada JF, Inami S, Aboodi MS, Tellez A, Milewski K, Wallace-Bradley D, Parker S, Rowland S, Nakazawa G, Vorpahl M, Kolodgie FD, Kaluza GL, Leon MB, Virmani R. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abluminal matrix. Circ Cardiovasc Interv. 2010 Jun 1;3(3):257-66. doi: 10.1161/CIRCINTERVENTIONS.109.919936. Epub 2010 May 4.

    PubMed 20442358

  • Nakazawa G, Granada JF, Alviar CL, Tellez A, Kaluza GL, Guilhermier MY, Parker S, Rowland SM, Kolodgie FD, Leon MB, Virmani R. Anti-CD34 antibodies immobilized on the surface of sirolimus-eluting stents enhance stent endothelialization. JACC Cardiovasc Interv. 2010 Jan;3(1):68-75. doi: 10.1016/j.jcin.2009.09.015.

    PubMed 20129572

  • Chandrasekhar J, Kok MM, Kalkman DN, Aquino MB, Zocca P, Woudstra P, Beijk MA, Kerkmeijer LS, Sartori S, Baber U, Tijssen JG, Koch KT, Dangas GD, Colombo A, Pocock S, von Birgelen C, Mehran R, de Winter RJ; COMBO Collaborators and BIO-RESORT Investigators. 1-Year Clinical Outcomes of All Comers Treated With 2 Bioresorbable Polymer-Coated Sirolimus-Eluting Stents: Propensity Score-Matched Comparison of the COMBO and Ultrathin-Strut Orsiro Stents. JACC Cardiovasc Interv. 2020 Apr 13;13(7):820-830. doi: 10.1016/j.jcin.2019.11.023.

    PubMed 32273094

  • Chandrasekhar J, Kerkmeijer LS, Kalkman DN, Sartori S, Aquino MB, Woudstra P, Beijk MA, Tijssen JG, Koch KT, Hajek P, Atzev B, Hudec M, Ong TK, Mates M, Borisov B, Warda HM, den Heijer P, Wojcik J, Iniguez A, Coufal Z, Khashaba A, Munawar M, Gerber RT, Yan BP, Lee M, Baber U, Dangas GD, Colombo A, de Winter RJ, Mehran R; MASCOT and REMEDEE investigators (full list of collaborators shown in the Appendix). Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration. Catheter Cardiovasc Interv. 2021 Apr 1;97(5):797-804. doi: 10.1002/ccd.28853. Epub 2020 Mar 21.

    PubMed 32198837

  • Kalkman DN, Kerkmeijer LS, Woudstra P, Menown IBA, Suryapranata H, den Heijer P, Iniguez A, van 't Hof AWJ, Erglis A, Arkenbout KE, Muller P, Koch KT, Tijssen JG, Beijk MAM, de Winter RJ. Three-year clinical outcomes after dual-therapy COMBO stent placement: Insights from the REMEDEE registry. Catheter Cardiovasc Interv. 2019 Sep 1;94(3):342-347. doi: 10.1002/ccd.28047. Epub 2018 Dec 18.

    PubMed 30565371

  • Kalkman DN, Woudstra P, Menown IBA, den Heijer P, Van't Hof AW, Erglis A, Suryapranata H, Arkenbout KE, Iniguez A, Muller P, Tijssen JG, Beijk MAM, de Winter RJ. Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry. Open Heart. 2017 Jul 11;4(2):e000634. doi: 10.1136/openhrt-2017-000634. eCollection 2017.

    PubMed 28761685

  • Woudstra P, Kalkman DN, den Heijer P, Menown IB, Erglis A, Suryapranata H, Arkenbout KE, Iniguez A, van 't Hof AW, Muller P, Tijssen JG, de Winter RJ. 1-Year Results of the REMEDEE Registry: Clinical Outcomes After Deployment of the Abluminal Sirolimus-Coated Bioengineered (Combo) Stent in a Multicenter, Prospective All-Comers Registry. JACC Cardiovasc Interv. 2016 Jun 13;9(11):1127-34. doi: 10.1016/j.jcin.2016.02.052. Epub 2016 May 18.

    PubMed 27209254

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Robbert J de Winter at 9 sites in 5 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 1 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: status not confirmed, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands, Latvia, Luxembourg, Spain, United Kingdom. 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?

Results are not available in the source record.

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?

Adjudicated Target Lesion Failure (time frame: 1 year post-procedure). 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 NCT01874002, which also lists 7 linked publications.

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 30 Dec 2015.

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