The objectives of this clinical investigation are to evaluate the clinical outcomes of the Ultimaster NagomiTM coronary drug eluting stent and to determine treatment practices and economic impact in complex subjects eligible for a percutaneous…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is Target Lesion Failure (TLF) defined as the composite of
cardiovascular death, target-vessel related myocardial infarction and
clinically driven target lesion revascularization at 1-year post-procedure.
Secondary outcome
Secondary endpoints will be evaluated post-procedure, at discharge, at 30
days, 6 months, 1 year and 2 years.
• Delivery success
• Procedure success
• Lesion success
• Device success
• Target lesion failure (TLF)
• Patient oriented composite endpoint (POCE)
• All death and subclassifications
• All myocardial infarction and subclassifications
• All revascularization and subclassifications
• All stent thrombosis and subclassifications
• All strokes and subclassifications
• All bleedings and subclassifications
• Balance between bleeding (BARC 3-5) and thrombotic event (myocardial
infarction and/or stent thrombosis)
• Utilization of cardiovascular health care resources
• Quality of Life (EQ-5D-5L)
• Angina status (Seattle Angina Questionnaire, SAQ-7)
• QCA of the index procedure angiogram for a subset of subjects with a Complex
Bifurcation Lesion (CBL)
Background summary
Advancement in Percutaneous Coronary Intervention (PCI) techniques such as
improvements in imaging equipment, stent design and implantation technique as
well as post-procedural pharmacological treatment have increased the number of
subjects eligible for stent implantation with improved acute and long-term
clinical outcomes.
Complex PCI subjects, defined by specific vessel and lesion characteristics,
represent a subject subset in whom the PCI procedure is technically more
challenging and associated with a higher risk for ischemic events. Complex
subjects constitute a considerable segment of the subjects seen in daily PCI
practice, but besides post-hoc subgroup analysis, no specific clinical study
has been performed to assess the outcomes in this growing subject population.
The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been
designed to expand the knowledge about outcomes with the Ultimaster NagomiTM
sirolimus eluting coronary stent system (Ultimaster NagomiTM) in complex PCI
subjects. The features for a complex PCI are based upon subgroup analysis of
earlier published studies.
Study objective
The objectives of this clinical investigation are to evaluate the clinical
outcomes of the Ultimaster NagomiTM coronary drug eluting stent and to
determine treatment practices and economic impact in complex subjects eligible
for a percutaneous coronary intervention.
The primary objective is to evaluate the clinical outcomes of the Ultimaster
NagomiTM stent in complex subjects at high ischemic risk eligible for a
percutaneous coronary intervention.
The secondary objectives are to assess:
• The deliverability of the Ultimaster NagomiTM stent.
• The balance between bleeding events and thrombotic events.
• Patient-reported outcomes (quality of life and angina status).
• Economic impact.
• Procedural angiographic outcomes by Quantitative Coronary Angiography (QCA)
in subjects with a bifurcation lesion.
Study design
The study is a prospective, multi-center, post-market clinical follow-up study
Study burden and risks
Since only data are collected as part of our study, there are no medical risks
associated with your participation in the study beyond the usual risk of a
stenting procedure.
Neither the treatment that has been proposed nor the diagnostic and monitoring
procedures for your clinical situation go beyond good medical practice. All
procedures will be as per standard hospital routine practice, and selected
sites are experienced in interventional procedures and in particular with
patients that have a medical condition. Therefore, participation in this study
does not impose additional risk to the participant while it will provide
additional knowledge of the treatment for the condition that might benefit
future patients.
Interleuvenlaan 40
Leuven 3001
NL
Interleuvenlaan 40
Leuven 3001
NL
Listed location countries
Age
Inclusion criteria
1) Age >= 18 years 2) Subject has been informed of the nature of the study and
agrees to its provisions, has provided written informed consent as approved by
the Institutional Review Board/Ethics Committee of the respective clinical site
3) Ischemic heart disease with an indication for a PCI with, if available in
the hospital, Heart Team consensus for a PCI procedure 4) Intention to treat
all lesions requiring a PCI with the Ultimaster NagomiTM stent 5) Subject meets
>= 1 of the complex procedure criteria: a) Multivessel PCI defined as >= 2 native
coronary arteries and/or venous or arterial bypass grafts treated with a stent
b) >= 3 stents implanted c) >= 3 lesions treated d) Complex bifurcation lesion
defined as true bifurcation lesion (Medina 1.1.1, 1.0.1 or 0.1.1) with a side
branch diameter >= 2.5 mm plus one of the following: i) side branch disease > 10
mm ii) calcified lesion iii) thrombotic lesion e) Bifurcation lesion implanted
with two stents f) Total stent length implanted > 60 mm g) Chronic total
occlusion defined as a 100% occlusion with antegrade TIMI 0 flow with at least
a 3-month duration h) Left main stenting (main stem and/or bifurcation) i)
Instent restenosis j) Severe calcified lesion with use of atherectomy,
lithotripsy or cutting balloon
Exclusion criteria
1) Any surgery requiring general anaesthesia, comorbidity or indication likely
necessitating the discontinuation of dual anti-platelet therapy before the
recommended duration of dual anti-platelet therapy per the ESC or national
guidelines 2) Hypersensitivity or contraindication to aspirin, heparin, L605
cobaltchromium alloy, sirolimus or its structurally related compounds, lactide
polymers or caprolactone polymers that cannot be pre-medicated 3) Known
contrast sensitivity that cannot be premedicated 4) Pregnant and breastfeeding
women 5) Life expectancy < 1 year for any cardiac or non-cardiac cause 6)
Participation in another clinical study that has not yet completed its primary
endpoint 7) Earlier enrolment in the NAGOMI COMPLEX PMCF STUDY 8) Unlikely to
be available for follow-up during the duration of the study (2 years)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84445.100.23 |