Clinical trial NCT01127958: DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent.
Official title: DARE-Trial: Drug Eluting bAlloon for In-stent REstenosis. Multi-center, Randomized Trial to Study the Effect of the SeQuent Please Drug-eluting Balloon Versus the Xience Prime Drug-eluting Stent for the Treatment of In-stent Restenosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: In-stent Restenosis
Keywords: In-stent restenosis
Minimal lumen diameter
Drug eluting balloon
Drug eluting stent
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: B. Braun Medical B.V.
First posted: 2010-05-21
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Background of the study:

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 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.

Study population:

The study population consists of 270 patients ( ≥ 18 years of age) with indication for PCI for in-stent restenosis of whom 135 are randomised to a drug eluting balloon and 135 are randomised to a drug eluting stent. Individuals have signed an informed consent for study measurements.

Intervention:

PCI with a drug-eluting stent, or PCI with a drug-eluting balloon.

Eligibility criteria: Inclusion Criteria:

* Restenosis of the initially stented main vessel, including ostial, left main and bifurcation lesions as well as venous or arterial grafts
* 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
* A reference diameter of ≥ 2.0 to 4.0 millimeters by visual estimation
* Amendable to PCI treatment with either the SeQuent ® Please DEB or the Xience™ Prime DES
* Amendable to dual antiplatelet treatment for the duration of 1 year
* Patients must be ≥ 18 years of age
* Patients must be able to understand the aim of the study, including risks, benefits and treatment alternatives
* Patients must agree to undergo a follow-up angiogram at 6 months (± 1 month)
* Patients must agree to undergo a clinical follow-up at 30 days, 6 months, 1, 2, 3, 4, and 5 years

Exclusion Criteria:

* The impossibility to arrange a follow-up coronary angiography at 6 months (± 1 month) after baseline procedure is considered an exclusion criterion for this study
* Patients have to meet the inclusion criteria;
* Life expectancy less than one year
* Severe renal insufficiency (glomerular filtration rate \<30mL/min), with exception of of patients with renal dialysis
* STEMI
* Restenosis in a biodegradable stent
* Restenosis in a non CE marked stent
* Requirement for PCI in the same vessel or expected in the next 6 months

Primary outcomes:
measure: The primary objective of this study is the minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI
timeFrame: 6 month's after PCI
Secondary outcomes:
measure: In-stent and in-segment percent Diameter Stenosis
timeFrame: 6 months
measure: In-stent and in-segment Angiographic binary restenosis
timeFrame: 6 months
measure: Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm
timeFrame: 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Amsterdam
country: Netherlands
facility: OLVG
city: Amsterdam
country: Netherlands
facility: VUmc
city: Blaricum
country: Netherlands
facility: Tergooi Ziekenhuizen
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer ziekenhuis
city: Nijmegen
country: Netherlands
facility: UMC St Radboud
city: Zwolle
country: Netherlands
facility: Isala klinieken
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jan Baan, Dr
role: PRINCIPAL_INVESTIGATOR
References: