Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up)
Brief summary
The study is designed as a prospective, multi-center, observational PMCF (post-market clinical follow-up) study of the Ultimaster Nagomi™ \_stent (lengths of 38, 44 and 50 mm) in the treatment of coronary artery disease according to the indications approved in the CE marking.
Detailed description
The study serves to fulfill post marketing surveillance requirements for the Ultimaster Nagomi™ stent. This is a PMCF study of real-world use of the Ultimaster Nagomi™ DES aimed to reaffirm the device claims of effectiveness and safety, no comparator is required to meet these specified objectives and endpoints.
Interventions
DEVICELONG NAGOMI
Patients in whom treatment with long nagomi has been attempted
Sponsors
Fundación EPIC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who meet ALL inclusion criteria will be included: * Patients aged ≥ 18 years AND; * Patients who according to standard practice of the hospital are amenable to PCI as indicated and considered adequate according to the European clinical practice guidelines on coronary revascularization AND; * Patients with at least one lesion fulfilling the "long lesion criteria" suitable for a single stent approach AND; * Patients who have been informed of the characteristics of the study and have provided written informed consent AND; * Intention to treat all lesions with the Ultimaster Nagomi™ stent
Exclusion criteria
* Patients must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 1 year | Target Lesion Failure defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization at 1-year post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success | Periprocedural | Device success defined as delivery success (achievement of successful delivery of study stent to the target lesion, expansion of the study stent and withdrawal of the delivery catheter) with a final residual diameter stenosis of the target lesion of \< 20% by visual assessment and/or \< 30% by QCA, using the assigned device only. |
| Safety of the stent: Freedom from Accidental dislodgement of the stent | Periprocedural | Safety of the stent defined as an absence of Accidental stent dislodgement |
| Safety of the stent: Freedom from Balloon rupture | Periprocedural | Safety of the stent defined as an absence of Balloon rupture o Hypotube rupture. |
| Safety of the stent: Freedom from Hypotube rupture o Hypotube rupture | Periprocedural | Safety of the stent defined as an absence of o Hypotube rupture o Hypotube rupture. |
| Safety of the procedure: Freedom from Challenging withdrawal | Periprocedural | Safety of the procedure defined as an absence of Challenging withdrawal |
| Safety of the procedure: Freedom from coronary perforation | Periprocedural | Safety of the procedure defined as an absence of coronary perforation |
| Safety of the procedure: Freedom from dissection >C | Periprocedural | Safety of the procedure defined as an absence of dissection \>C |
| Safety of the procedure: Freedom from no-reflow | Periprocedural | Safety of the procedure defined as an absence of no-reflow |
| Safety of the procedure: Freedom from stent thrombosis | Periprocedural | Safety of the procedure defined as an absence stent thrombosis |
| Procedure success | Periprocedural | To assess the procedure success rate defined as the achievement of \< 20% residual stenosis by visual assessment in all target lesions using any percutaneous method without the occurrence of death, Q wave or WHO defined non-Q wave myocardial Infarction, or need for new revascularization of the target lesion during the hospital stay. |
| Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions | Periprocedural | To assess Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions |
| Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels | Periprocedural | To assess Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels |
| Performance of the Ultimaster Nagomi™ stent in Distal vessels | Periprocedural | To assess Performance of the Ultimaster Nagomi™ stent in Distal vessels |
| Angina status assessment Seattle Angina Questionnaire (SAQ) | Baseline | Angina status assessment Seattle Angina Questionnaire (SAQ) |
| Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire | After PCI | Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire |
| Cardiovascular death | 12 months | Percentage of cardiovascular death |
| Target-vessel related myocardial infarction | 12 Months | Percentage of target-vessel related myocardial infarction |
| Clinically driven target lesion revascularization | 12 months | Percentage of clinically driven target lesion revascularization |
Countries
Spain
Contacts
CONTACTTAMARA GARCIA CAMARERO, MD, PhD
CONTACTFUNDACION EPIC
Outcome results
None listed