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

Coronary Artery Disease Clinical Trial

— REMEDEE Reg  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01874002
• Other study ID #: W12_186
• Secondary ID: Version 2.0
• Status: Active, not recruiting
• Phase: N/A
• First received: June 6, 2013
• Last updated: December 29, 2015
• Start date: June 2013
• Est. completion date: March 2019

Study information

• Verified date: December 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)United Kingdom: Research Ethics CommitteeLatvia: Institutional Review BoardLuxembourg: Comite National d'Ethique de RechercheSpain: Comité Ético de Investigación Clínica
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: March 2019
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Latvia	Pauls Stradins Clinical University Hospital	Riga
Luxembourg	Centre Hospitalier de Luxembourg	Luxembourg
Netherlands	Academic Medical Center - University of Amsterdam	Amsterdam
Netherlands	Ter Gooi Ziekenhuizen	Blaricum
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Radboud UMC	Nijmegen
Netherlands	Isala Klinieken	Zwolle
Spain	Meixoeiro Hospital	Vigo
United Kingdom	Craigavon Cardiac Centre	Craigavon

Sponsors (1)

Lead Sponsor	Collaborator
Robbert J de Winter

Countries where clinical trial is conducted

Latvia,  Luxembourg,  Netherlands,  Spain,  United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year post-procedure	No
Secondary	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).	30 days post-procedure	No
Secondary	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).	180 days post procedure	No
Secondary	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)	1 year post-procedure	No
Secondary	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)	30 days post-procedure	No
Secondary	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)	180 days post-procedure	No
Secondary	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)	1 year post-procedure	No
Secondary	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	1 year post-procedure	No
Secondary	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	30 days post-procedure	No
Secondary	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	180 days post-procedure	No
Secondary	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	1 year post-procedure	No
Secondary	Adjudicated stent thrombosis (definite/probable/possible)	Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions	1 year post-procedure	No
Secondary	Adjudicated stent thrombosis (definite/probable/possible)	Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions	30 days post-procedure	No
Secondary	Adjudicated stent thrombosis (definite/probable/possible)	Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions	180 days post-procedure	No
Secondary	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	Procedural	No
Secondary	Procedure success	Successful stent placement and no periprocedural complications.	Procedural	No
Secondary	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).	2 years post-procedure	No
Secondary	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).	3 years post-procedure	No
Secondary	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).	4 years post-procedure	No
Secondary	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).	5 years post-procedure	No
Secondary	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)	2 years post-procedure	No
Secondary	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)	3 years post-procedure	No
Secondary	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)	4 years post-procedure	No
Secondary	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)	5 years post-procedure	No
Secondary	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	2 years post-procedure	No
Secondary	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	3 years post-procedure	No
Secondary	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	4 years post-procedure	No
Secondary	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	5 years post-procedure	No
Secondary	Adjudicated stent thrombosis (definite/probable/possible)	Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions	2 years post-procedure	No
Secondary	Adjudicated stent thrombosis (definite/probable/possible)	Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions	3 years post-procedure	No
Secondary	Adjudicated stent thrombosis (definite/probable/possible)	Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions	4 years post-procedure	No
Secondary	Adjudicated stent thrombosis (definite/probable/possible)	Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions	5 years post-procedure	No