An observational study in Coronary Artery Disease and Atherosclerosis, sponsored by OrbusNeich. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by OrbusNeich · Observational
To collect post marketing surveillance data on patients receiving at least one Combo Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Combo Stent in routine clinical practice.
The multicenter, multinational, prospective registry population consists of patients who undergo percutaneous coronary intervention (PCI) with (attempted) placement of at least one Combo Stent (according to the Instructions for use) as part of routine clinical care. Approximately 2,500 patients from 50 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for one year. The registry is considered finished when all patients have completed the 12 month follow-up.
A follow-up is scheduled at 30 days, 6 months and 12 months post procedure. Follow-up is obtained at a planned regular visit to the outpatient clinic, or by telephone contact with the patient.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 2,500 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →OrbusNeich is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients who undergo PCI with (attempted) placement of at least one Combo Stent as part of routine clinical care are entered into the registry. PCI with a Combo Stent is considered attempted when the operator has passed the Combo Stent across the guiding catheter.
In general, consecutive patients are included in the registry. Patients are only excluded from registration if ANY of the following conditions apply:
The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.
Adjudicated device-oriented composite target lesion failure (TLF)
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 non-target vessel, or ischemia-driven target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting (CABG)) at 12 months post procedure.
Time frame: 12 months post procedure
Adjudicated TLF
Time frame: at index procedure, 30 days, 6 months and 12 months post procedure
Each of the components of TLF (Cardiac death, Non-fatal MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR))
Time frame: at index procedure, 30 days, 6 months, 12 months
Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) as a composite of all Death, any MI and ischemia-driven revascularization (TLR/TVR/non-TVR)
Time frame: at index procedure, 30 days, 6 months and 12 months
Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)
Time frame: at index procedure, 30 days, 6 months and 12 months
Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition
Time frame: at index procedure, 30 days, 6 months and 12 months post-procedure
Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition
Time frame: at index procedure, 30 days, 6 months and 12 months post-procedure
Adjudicated stroke
Time frame: at index procedure, 30 days, 6 months and 12 months
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
Time frame: Index Procedure
Procedure success: Successful stent placement and no peri-procedural complications.
Time frame: Index procedure
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
OrbusNeich