The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Coronary in-stent restenosis is commonly treated by using a drug eluting stent
(DES). There are, however, some concerns about the safety of drug eluting
stents, in particular with respect to delayed healing, chronic inflammatory
reaction, and late or very late stent thrombosis. It is unknown whether the
current treatment with another layer of stents may add to the risk of stent
thrombosis or reoccurrence of restenosis.
Therefore, the relatively new drug-eluting balloons may provide an alternative
for treatment of in-stent restenosis, avoiding a double stent layer. The
expected advantages of such drug-eluting balloons over stents are the ease of
access of the lesion, the absence of a multiple stent layer, and the shorter
necessity of the use of dual antiplatelet therapy. Several studies have
demonstrated safety and efficacy of the Sequent Please drug-eluting balloon
(DEB). Whether the drug eluting balloon is as effective as a drug eluting stent
in preventing re-restenosis is not known.
Study objective
The main objective of the study is to determine whether PCI for in-stent
restenosis with a drug eluting balloon is angiographically non-inferior to PCI
with a drug eluting stent at 6 month follow up.
Study design
The study is designed as an multi-center, randomized, prospective two-arm trial
with either PCI with a drug eluting balloon or a drug eluting stent for
in-stent restenosis. Blinded evaluation of endpoints by independent core
laboratory.
Intervention
PCI with a drug-eluting stent, or PCI with a drug-eluting balloon.
Study burden and risks
Clinical follow-up (telephonically) 30 days, 1, 2, 3, 4 and 5 years
post-procedure.
Re-coronairy angiography at 6 months post-procedure. The risks of the
re-coronairy angiography are the same as every coronairy angiography.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
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 < 5 mm out of the stent
Amendable to PCI treatment with either the SeQuent Please DEB or the Xience Prime DES
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
Recruitment
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 | NL31487.018.10 |
| Other | TC=2189 |