- ICH GCP
- US Clinical Trials Registry
- 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.
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amsterdam, Netherlands
- OLVG
-
Amsterdam, Netherlands
- VUmc
-
Amsterdam, Netherlands, 1105AZ
- Academisch Medisch Centrum
-
Blaricum, Netherlands
- Tergooi ziekenhuizen
-
Breda, Netherlands
- Amphia Ziekenhuis
-
Dordrecht, Netherlands, 3300AK
- Albert Schweitzer Ziekenhuis
-
Nijmegen, Netherlands, 6500HB
- UMC St Radboud
-
Zwolle, Netherlands
- Isala Klinieken
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SeQuent Please
PCI with drug-eluting balloon
|
PCI with a drug-eluting balloon for in-stent restenosis
|
Active Comparator: Xience Prime
PCI with a drug-eluting stent
|
PCI with a drug-eluting stent for in-stent restenosis
|
What is the study measuring?
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
Time Frame: 6 month's 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 |
Time Frame |
---|---|
In-stent and in-segment percent Diameter Stenosis
Time Frame: 6 months
|
6 months
|
In-stent and in-segment Angiographic binary restenosis
Time Frame: 6 months
|
6 months
|
Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jan Baan, Dr, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NL3148701810
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on In-stent Restenosis
-
Assiut UniversityNot yet recruiting
-
Luzerner KantonsspitalUnknown
-
Fundación Médica para la Investigación y Desarrollo...Abbott Medical Devices; Hospital San Carlos, Madrid; B.Braun Surgical SAUnknown
-
Cordis CorporationCompletedIn-Stent RestenosisUnited States
-
Boston Scientific CorporationActive, not recruiting
-
Klinikum CoburgUnknown
-
Seoul National University HospitalUnknownIn-stent Restenosis LesionKorea, Republic of
-
Midwest Cardiovascular Research FoundationCompletedFemoropopliteal In-stent RestenosisUnited States
-
Spanish Society of CardiologyAbbott Medical Devices; Terumo Medical Corporation; Fundación de Investigación... and other collaboratorsUnknownCoronary In-stent RestenosisSpain
-
Spectranetics CorporationYale UniversityWithdrawnFemoropopliteal In-Stent RestenosisColombia
Clinical Trials on PCI with a drug-eluting balloon
-
Chinese PLA General HospitalUnknown
-
Henan Institute of Cardiovascular EpidemiologyRecruiting
-
Fatebenefratelli and Ophthalmic HospitalCompletedCardiovascular Diseases
-
Xuzhou Third People's HospitalNot yet recruitingCoronary Artery Disease | Bifurcation Lesion
-
Helsinki University Central HospitalCompletedVascular Access Complication | Restenosis, Vascular Graft | Dialysis Related Complications
-
Poznan University of Medical SciencesCompleted
-
ZhuHai Cardionovum Medical Device Co., Ltd.R&G Pharma Studies Co.,Ltd.Completed
-
Fundacja Ośrodek Badań MedycznychCompletedMyocardial InfarctionPoland, Slovenia
-
University Hospital UlmRecruitingChronic Total Occlusion | Chronic Total Occlusion of Coronary ArteryGermany
-
IGLESIAS Juan FernandoUniversity of BernRecruitingVascular Access Site OcclusionSwitzerland, Greece, Italy, Belgium