REMEDEE Reg: Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent
Study Details
Study Description
Brief 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. 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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Adjudicated Target Lesion Failure [1 year post-procedure]
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 [30 days post-procedure]
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 [180 days post procedure]
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) [1 year post-procedure]
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) [30 days post-procedure]
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) [180 days post-procedure]
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) [1 year post-procedure]
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) [1 year post-procedure]
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) [30 days post-procedure]
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) [180 days post-procedure]
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) [1 year post-procedure]
Each of the individual components of MACE: All death Any myocardial infarction Any revascularization
- Adjudicated stent thrombosis (definite/probable/possible) [1 year post-procedure]
Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions
- Adjudicated stent thrombosis (definite/probable/possible) [30 days post-procedure]
Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions
- Adjudicated stent thrombosis (definite/probable/possible) [180 days post-procedure]
Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions
- Device success [Procedural]
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 [Procedural]
Successful stent placement and no periprocedural complications.
- Adjudicated Target Lesion Failure [2 years post-procedure]
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 [3 years post-procedure]
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 [4 years post-procedure]
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 [5 years post-procedure]
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) [2 years post-procedure]
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) [3 years post-procedure]
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) [4 years post-procedure]
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) [5 years post-procedure]
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) [2 years post-procedure]
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) [3 years post-procedure]
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) [4 years post-procedure]
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) [5 years post-procedure]
Adjudicated patient-oriented composite MACE as a composite of: All death Any myocardial infarction Any revascularization
- Adjudicated stent thrombosis (definite/probable/possible) [2 years post-procedure]
Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions
- Adjudicated stent thrombosis (definite/probable/possible) [3 years post-procedure]
Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions
- Adjudicated stent thrombosis (definite/probable/possible) [4 years post-procedure]
Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions
- Adjudicated stent thrombosis (definite/probable/possible) [5 years post-procedure]
Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pauls Stradins Clinical University Hospital | Riga | Latvia | LV-1002 | |
| 2 | Centre Hospitalier de Luxembourg | Luxembourg | Luxembourg | ||
| 3 | Academic Medical Center - University of Amsterdam | Amsterdam | Netherlands | 1105AZ | |
| 4 | Ter Gooi Ziekenhuizen | Blaricum | Netherlands | ||
| 5 | Amphia Ziekenhuis | Breda | Netherlands | ||
| 6 | Radboud UMC | Nijmegen | Netherlands | ||
| 7 | Isala Klinieken | Zwolle | Netherlands | ||
| 8 | Meixoeiro Hospital | Vigo | Spain | ||
| 9 | 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
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- W12_186
- Version 2.0