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.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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In-stent Restenosis

Intervention / Treatment
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* Device: PCI with a drug-eluting balloon
* Device: PCI with a drug-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SeQuent Please<br>PCI with drug-eluting balloon | Device: PCI with a drug-eluting balloon<br>* PCI with a drug-eluting balloon for in-stent restenosis<br>|
| Active Comparator: Xience Prime<br>PCI with a drug-eluting stent | Device: PCI with a drug-eluting stent<br>* PCI with a drug-eluting stent for in-stent restenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is the minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI | 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. | 6 month's after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent and in-segment percent Diameter Stenosis |  | 6 months | 
| In-stent and in-segment Angiographic binary restenosis |  | 6 months | 
| Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-stent restenosis, Minimal lumen diameter, Drug eluting balloon, Drug eluting stent