Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent (REMEDEE Reg)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Robbert J de Winter, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01874002
First received: June 6, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: Combo stent

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Adjudicated Target Lesion Failure [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Adjudicated Target Lesion Failure [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]
    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).

  • Adjudicated Target Lesion Failure [ Time Frame: 180 days post procedure ] [ Designated as safety issue: No ]
    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).

  • Individual components of target lesion failure (TLF) [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: No ]

    Individual components of target lesion failure (TLF):

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

  • Individual components of target lesion failure (TLF) [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]

    Individual components of TLF:

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

  • Individual components of target lesion failure (TLF) [ Time Frame: 180 days post-procedure ] [ Designated as safety issue: No ]

    Individual components of TLF:

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

  • Individual components of target lesion failure (TLF) [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: No ]

    Individual components of TLF:

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

  • Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: No ]

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

  • Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

  • Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [ Time Frame: 180 days post-procedure ] [ Designated as safety issue: No ]

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

  • Each of the individual components of Major Adverse Cardiac Events(MACE) [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: No ]

    Each of the individual components of MACE:

    • All death
    • Any myocardial infarction
    • Any revascularization

  • Adjudicated stent thrombosis (definite/probable/possible) [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: No ]
    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

  • Adjudicated stent thrombosis (definite/probable/possible) [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]
    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

  • Adjudicated stent thrombosis (definite/probable/possible) [ Time Frame: 180 days post-procedure ] [ Designated as safety issue: No ]
    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

  • Device success [ Time Frame: Procedural ] [ Designated as safety issue: No ]
    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

  • Procedure success [ Time Frame: Procedural ] [ Designated as safety issue: No ]
    Successful stent placement and no periprocedural complications.

  • Adjudicated Target Lesion Failure [ Time Frame: 2 years post-procedure ] [ Designated as safety issue: No ]
    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).

  • Adjudicated Target Lesion Failure [ Time Frame: 3 years post-procedure ] [ Designated as safety issue: No ]
    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).

  • Adjudicated Target Lesion Failure [ Time Frame: 4 years post-procedure ] [ Designated as safety issue: No ]
    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).

  • Adjudicated Target Lesion Failure [ Time Frame: 5 years post-procedure ] [ Designated as safety issue: No ]
    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).

  • Individual components of target lesion failure (TLF) [ Time Frame: 2 years post-procedure ] [ Designated as safety issue: No ]

    Individual components of target lesion failure (TLF):

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

  • Individual components of target lesion failure (TLF) [ Time Frame: 3 years post-procedure ] [ Designated as safety issue: No ]

    Individual components of target lesion failure (TLF):

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

  • Individual components of target lesion failure (TLF) [ Time Frame: 4 years post-procedure ] [ Designated as safety issue: No ]

    Individual components of target lesion failure (TLF):

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

  • Individual components of target lesion failure (TLF) [ Time Frame: 5 years post-procedure ] [ Designated as safety issue: No ]

    Individual components of target lesion failure (TLF):

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

  • Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [ Time Frame: 2 years post-procedure ] [ Designated as safety issue: No ]

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

  • Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [ Time Frame: 3 years post-procedure ] [ Designated as safety issue: No ]

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

  • Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [ Time Frame: 4 years post-procedure ] [ Designated as safety issue: No ]

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

  • Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [ Time Frame: 5 years post-procedure ] [ Designated as safety issue: No ]

    Adjudicated patient-oriented composite MACE as a composite of:

    • All death
    • Any myocardial infarction
    • Any revascularization

  • Adjudicated stent thrombosis (definite/probable/possible) [ Time Frame: 2 years post-procedure ] [ Designated as safety issue: No ]
    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

  • Adjudicated stent thrombosis (definite/probable/possible) [ Time Frame: 3 years post-procedure ] [ Designated as safety issue: No ]
    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

  • Adjudicated stent thrombosis (definite/probable/possible) [ Time Frame: 4 years post-procedure ] [ Designated as safety issue: No ]
    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions

  • Adjudicated stent thrombosis (definite/probable/possible) [ Time Frame: 5 years post-procedure ] [ Designated as safety issue: No ]
    Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions


Estimated Enrollment: 1000
Study Start Date: June 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Combo stent
Consecutive patients in whom a treatment with a Combo stent in the setting of routine clinical care is attempted are entered into the registry.
Device: Combo stent
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.
Other Names:
  • COMBO stent
  • Abluminal Sirolimus Coated Bio-Engineered Stent
  • Combo Bio-Engineered Sirolimus Eluting Stent
  • SirolimusECS

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01874002

Locations
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV-1002
Luxembourg
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg
Netherlands
Academic Medical Center - University of Amsterdam
Amsterdam, Netherlands, 1105AZ
Ter Gooi Ziekenhuizen
Blaricum, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Radboud UMC
Nijmegen, Netherlands
Isala Klinieken
Zwolle, Netherlands
Spain
Meixoeiro Hospital
Vigo, Spain
United Kingdom
Craigavon Cardiac Centre
Craigavon, United Kingdom
Sponsors and Collaborators
Robbert J de Winter
Investigators
Principal Investigator: Robbert J de Winter, MD, PhD Academic Medical Centre - University of Amsterdam
  More Information

Publications:
Responsible Party: Robbert J de Winter, Professor of Clinical Cardiology, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01874002     History of Changes
Other Study ID Numbers: W12_186, Version 2.0
Study First Received: June 6, 2013
Last Updated: March 18, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
United Kingdom: Research Ethics Committee
Latvia: Institutional Review Board
Luxembourg: Comite National d'Ethique de Recherche
Spain: Comité Ético de Investigación Clínica

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014