The aim of this study is to improve clinical outcomes in patients with insulin-treated DM after coronary stent placement in the treatment of coronary artery disease with drug-eluting balloon therapy after stent placement.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In-stent late lumen loss at 9 months follow-up, measured with optical coherence
tomography, after PCI with drug-eluting stent followed by drug-coated balloon
compared with in-stent late lumen loss after PCI with drug-eluting stent alone
in a single lesion.
Secondary outcome
Device Success at 24 hours; Target Lesion Failure (composite of cardiac death,
target vessel myocardial infarction, target lesion revascularization) at 9, 12
and 24 months.
Background summary
The prevalence of patients with Diabetes Mellitus (DM) is rising globally. One
in three Dutch adults will develop DM type 2 during their life. Patients with
DM are at high risk of atherosclerosis and coronary artery disease (CAD).
Despite improved clinical outcomes after percutaneous coronary intervention
(PCI) with drug-eluting stents (DES) in non-diabetic patients, numerous studies
show poor outcomes in diabetic patients post stent placement.In non-DM
patients, in-stent restenosis rates after PCI with DES are approximately 4-5%
in the first year. In contrast, in DM patients treated with a DES, the in-stent
restenosis rates exceeds 10% at one year follow-up. Moreover, the most
vulnerable are patients with insulin treated DM (ITDM), with repeat
revascularization rates observed as high as 20% at one year follow-up. The
difference in outcomes between diabetic and non-diabetic patients treated with
PCI is primarily caused by increased in-stent restenosis caused by neointimal
hyperplasia and neoatherosclerosis in the stented area. This results in higher
repeat revascularization rates, but also in higher rates of target vessel
myocardial infarction and cardiac mortality as some patients experience an
acute coronary syndrome due to in-stent restenosis.
Study objective
The aim of this study is to improve clinical outcomes in patients with
insulin-treated DM after coronary stent placement in the treatment of coronary
artery disease with drug-eluting balloon therapy after stent placement.
Study design
This is a prospective, multicenter, randomized, single-blind
investigator-initiated proof-of-concept study to evaluate the effect of
drug-eluting ballon on luminal neoatherosclerosis and neointimal hyperplasia in
patients with ITDM at 9 months post stent placement with optical coherence
tomography (OCT).
Intervention
Standard treatment (drug-eluting stent placement) versus standard treatment
with drug-eluting balloon in patients with insulin-dependent diabetes mellitus.
Study burden and risks
The treatment with the drug-eluting ballon could reduce the risk of in-stent
restenosis, however this effect has not been established.
Risks of participating in this study are associated with the additional
coronary angiography with OCT. The addition of radiation 0.8 mSv.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Insulin-treated diabetes mellitus with coronary artery disease, planned for percutaneous coronary intervention with drug-eluting stent.
Exclusion criteria
Unable to provide informed consent.
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL67496.018.18 |
| OMON | NL-OMON24439 |