No registrations found.
ID
Source
Brief title
Health condition
Coronary artery disease in insulin-treated diabetic patients
Sponsors and support
Intervention
Outcome measures
Primary outcome
Late lumen loss at 9 months follow-up
Secondary outcome
In-stent neointimal hyperplasia volume, target lesion failure, stent thrombosis, angina pectoris
Background summary
Pilot trial randomizing 50 insulin-treated diabetic patients to either drug-eluting stent alone or durg-eluting balloon post drug-eluting stent implantation.
Study objective
In-stent restenosis rate is higher in diabetic than non-diabetic patients. A higher dose of -limus together with a more homogeneous spread will lower this rate of restenosis.
Study design
Index, 9 months, 12 and 24 months
Intervention
Drug-eluting balloon post drug-eluting stenting
Inclusion criteria
Subject must be above 18 years of age, must have ischemic heart disease that requires PCI, has one or more target lesion(s) suitable for DES implantation, must have insulin-treated diabetes mellitus
Exclusion criteria
Subject present with STEMI. Target lesion is total occlusion, unprotected left main, located within a graft, instent restenosis, bifurcation with 2-vessel stenting, treatment plan includes stent overlapping
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7977 |
| CCMO | NL67496.018.18 |
| OMON | NL-OMON48509 |