in-stent restenosis stenosis of earlier implanted stent
Conditions
Interventions
PCI with a drug-eluting stent, or PCI with a drug-eluting balloon.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Restenosis of initially stented coronary artery Restenosis of any type of stent; all drug-eluting stents or bare metal stents Restenosis must be present > 50% in-stent and
Exclusion criteria
Exclusion criteria: The impossibility to arrange a follow-up coronary angiography at 6 months (± 1 month) after baseline procedure Life expectancy less than one year In-stent re-restenosis already treated with a second stent Requirement for PCI in the same vessel or expected in the next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine whether PCI with the SeQuent ® Please DEB versus PCI with the Xience* Prime DES for the treatment of patients with in-stent restenosis is non-inferior with respect to minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are the following parameters:In-stent and in-segment percent Diameter Stenosis (% DS) at 6 months, in-stent and in-segment Angiographic Binary Restenosis (ABR) rate at 6 months, aneurysm, thrombosis and persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up) at 6 months, cardiac death, myocardial infarction, unless originating from a un-treated vessel, target vessel re-vascularization, either by PCI or CABG, stent thrombosis, ischemia driven target vessel re-stenosis, not amenable to re-vascularization. | — |
Countries
Netherlands
Outcome results
None listed