Coronary Artery Disease
Conditions
Keywords
stent, DES, Inspiron
Brief summary
Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of real-world patients.
Detailed description
Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0 mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent. Stent implantation should be performed according to the Instructions for Use and according to the local practice. It is recommended that ECG and cardiac enzymes are collected before and after procedure. Dual anti-platelet therapy is recommended for at least 6 months after procedure. Patients will be followed at 30 days, 1 and 2 years after procedure.
Interventions
DEVICEimplant
coronary stent implantation
Sponsors
Scitech Produtos Medicos Ltda
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years
Exclusion criteria
* Safein Vein or Left Internal Mammary artery Grafts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events Rate | 12 months | Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel and Lesion Revascularization Rates | 24 months | Target Vessel and Lesion Revascularization |
| Stent Thrombosis Rate | 24 months | Stent Thrombosis |
Countries
Brazil
Outcome results
None listed