The primairy objective of this study is to evaluate the safety and efficacy of the Janus OPTIMA stent in the treatment of the novo lesions in native cotronary arteries with a maximum lenght of 28 mm and a diameter of 2.5 - 4.0 mm
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of adjudicated composite rate of cardiac death, MI, clinically driven
TLR at 6 months
Secondary outcome
Incidence of adjudicated composite rate of all death, MI, TVR at 6 months, 1
and 2 years
Adjudicated thrombosis rate according to ARC (Academic Research Consortium)
definition for each follow-up period; LLL (Late Lumen Loss) at 8 months
(subgroup analysis)
Background summary
This is a prospective, non-randomised, multicenter registry. The patients*
clinical data will be recorded on a CRF accessible by Internet connection.
eOPTIMA is a post market registry designed to evaluate, in everyday clinical
practice, the performance of the device Janus OPTIMA in *real world*
population. The *real world* registries are extremely important as eliminate
the limitations related to the subjects* selection in the randomized coronary
trials. The data collected through this electronic registry will allow us to
compare the Optima results with those obtained in eJanus, being both *real
world* registries.
Study objective
The primairy objective of this study is to evaluate the safety and efficacy of
the Janus OPTIMA stent in the treatment of the novo lesions in native
cotronary arteries with a maximum lenght of 28 mm and a diameter of 2.5 - 4.0 mm
Study design
It's a prospective, non-randomised, multicenter registry. The patients clinical
data will be recorded on a CRF accessible by Internet connection
Study burden and risks
The risks related to this trial are related to the procedure or the device but
are not expected to be different than a normal standard procedure with a
different kind of stent. The entolled subjects will be followed more accurately
through clinical phone questionnaire, that could evidence the need of
re-hospitalization, and have their pathology carefully followed through
angiographic examination
Strada Crescentino s/n
13040 Saluggia (VC)
Italy
Strada Crescentino s/n
13040 Saluggia (VC)
Italy
Listed location countries
Age
Inclusion criteria
Subjects >18 years of age
Subjects who are eligible for CABG surgery
Subjects diagnosed with the-novo coronary lesion(s) with a diameter stenosis >50% and <100% (visual estimation)
Exclusion criteria
Subjects involved in other clinical trials with any investigational drug or device
Women who are pregnant or who have the potential to become pregnant during the study
Subjects previously implanted with a coronary stent in the target lesion
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 | NL23934.060.08 |