The main objective of the present study is to investigate whether the ORSIRO coronary stent is non-inferior compared to the Xience coronary stent in patients with total coronary occlusions.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
in-segment late luminal loss at 9 months follow-up angiography
Secondary outcome
-angiografische in-stent late luminal loss, in-stent en in-segment restenose na
9 maanden
- targetvessel en target lesion revascularisatie
- Major adverse cardiac events
- acute en subacute stent thrombose
Background summary
Primary intracoronary stent placement after successfully crossing chronic total
coronary occlusions (CTO) decreases the high restenosis rate at long-term
follow-up compared with conventional balloon angioplasty. Several studies have
shown the efficacy of drug-eluting stents in selected groups of patients. In
the PRISON II AND III study we demonstrated that drug-eluting stents were
superior to bare metal stents in CTO. In this prospective randomized trial,
implantation of ORSIRO sirolimus-eluting stents with bio-resorbable polymer
coating will be compared to Xience everolimus-eluting stent with permanent
polymer coating implantation for the treatment of total coronary occlusions.For
a complete overview: see http://www.clinicaltrials.gov
Study objective
The main objective of the present study is to investigate whether the ORSIRO
coronary stent is non-inferior compared to the Xience coronary stent in
patients with total coronary occlusions.
Study design
prospective, randomized, single blinded, controlled, multi-center
Intervention
recanalization of the occluded coronary artery with placement of either the
ORSIRO or XIENCE stent
Study burden and risks
Additional investigations for patients in this study include a standard
angiography at 9 months follow-up, in 60 patients an OCT, informed consent
procedure and once a year telephone follow-up. All other procedures during the
study are standard treatment procedures. Participation in the study has little
additional risk compared to standard treatment.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
1) the estimated duration of the occlusion is at least 4 weeks.
2) signs of ischemia related to the occluded coronary artery.
3) successful recanalization of the occluded artery is achieved.
Exclusion criteria
1) primary or rescue PCI for acute myocardial infarction
2) the lesion could not be crossed.
3) lesions with complex anatomy making successful stent deployment unlikely.
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 |
|---|---|
| ClinicalTrials.gov | NCT01516723 |
| CCMO | NL37520.100.11 |