Clinical trial NCT01874002: Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
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
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Adjudicated Target Lesion Failure
timeFrame: 1 year post-procedure
Secondary outcomes:
measure: Adjudicated Target Lesion Failure
timeFrame: 30 days post-procedure
measure: Adjudicated Target Lesion Failure
timeFrame: 180 days post procedure
measure: Individual components of target lesion failure (TLF)
timeFrame: 1 year post-procedure
measure: Individual components of target lesion failure (TLF)
timeFrame: 30 days post-procedure
measure: Individual components of target lesion failure (TLF)
timeFrame: 180 days post-procedure
measure: Individual components of target lesion failure (TLF)
timeFrame: 1 year post-procedure
measure: Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)
timeFrame: 1 year post-procedure
measure: Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)
timeFrame: 30 days post-procedure
measure: Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)
timeFrame: 180 days post-procedure
measure: Each of the individual components of Major Adverse Cardiac Events(MACE)
timeFrame: 1 year post-procedure
measure: Adjudicated stent thrombosis (definite/probable/possible)
timeFrame: 1 year post-procedure
measure: Adjudicated stent thrombosis (definite/probable/possible)
timeFrame: 30 days post-procedure
measure: Adjudicated stent thrombosis (definite/probable/possible)
timeFrame: 180 days post-procedure
measure: Device success
timeFrame: Procedural
measure: Procedure success
timeFrame: Procedural
measure: Adjudicated Target Lesion Failure
timeFrame: 2 years post-procedure
measure: Adjudicated Target Lesion Failure
timeFrame: 3 years post-procedure
measure: Adjudicated Target Lesion Failure
timeFrame: 4 years post-procedure
measure: Adjudicated Target Lesion Failure
timeFrame: 5 years post-procedure
measure: Individual components of target lesion failure (TLF)
timeFrame: 2 years post-procedure
measure: Individual components of target lesion failure (TLF)
timeFrame: 3 years post-procedure
measure: Individual components of target lesion failure (TLF)
timeFrame: 4 years post-procedure
measure: Individual components of target lesion failure (TLF)
timeFrame: 5 years post-procedure
measure: Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)
timeFrame: 2 years post-procedure
measure: Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)
timeFrame: 3 years post-procedure
measure: Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)
timeFrame: 4 years post-procedure
measure: Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE)
timeFrame: 5 years post-procedure
measure: Adjudicated stent thrombosis (definite/probable/possible)
timeFrame: 2 years post-procedure
measure: Adjudicated stent thrombosis (definite/probable/possible)
timeFrame: 3 years post-procedure
measure: Adjudicated stent thrombosis (definite/probable/possible)
timeFrame: 4 years post-procedure
measure: Adjudicated stent thrombosis (definite/probable/possible)
timeFrame: 5 years post-procedure
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
city: Amsterdam
country: Netherlands
facility: Academic Medical Center - University of Amsterdam
city: Blaricum
country: Netherlands
facility: Ter Gooi Ziekenhuizen
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Vigo
country: Spain
facility: Meixoeiro Hospital
city: Craigavon
country: United Kingdom
facility: Craigavon Cardiac Centre
Study officials:
affiliation: Academic Medical Centre - University of Amsterdam
name: Robbert J de Winter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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citation: 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.
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citation: 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.
citation: 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.