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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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborator:
B. Braun Medical b.v.
Information provided by (Responsible Party):
J. Baan, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01127958
First received: May 18, 2010
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
In-stent Restenosis
Device: PCI with a drug-eluting balloon
Device: PCI with a drug-eluting stent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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.

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Measures:
  • In-stent and in-segment percent Diameter Stenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • In-stent and in-segment Angiographic binary restenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: May 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SeQuent Please
PCI with drug-eluting balloon
Device: PCI with a drug-eluting balloon
PCI with a drug-eluting balloon for in-stent restenosis
Active Comparator: Xience Prime
PCI with a drug-eluting stent
Device: PCI with a drug-eluting stent
PCI with a drug-eluting stent for in-stent restenosis

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127958

Contacts
Contact: Jan Baan, Dr. 00315664585 J.Baan@amc.uva.nl

Locations
Netherlands
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105AZ
Contact: Jan Baan, Dr.    0031205664585    J.Baan@amc.uva.nl   
Principal Investigator: Jan Baan, MD; PhD         
OLVG Recruiting
Amsterdam, Netherlands
Contact: R.J. van der Schaaf, Dr.         
Principal Investigator: R.J. van der Schaaf, MD; PhD         
VUmc Recruiting
Amsterdam, Netherlands
Contact: N. van Royen, Dr.         
Principal Investigator: N. van Royen, MD; PhD         
Tergooi Ziekenhuizen Recruiting
Blaricum, Netherlands
Contact: R. van Stralen         
Principal Investigator: R. van Stralen         
Amphia Ziekenhuis Recruiting
Breda, Netherlands
Contact: M. Meuwissen, Dr.         
Principal Investigator: P. den Heijer, MD; PhD         
Albert Schweitzer ziekenhuis Recruiting
Dordrecht, Netherlands, 3300AK
Contact: A. Dirkali         
Principal Investigator: A. Dirkali, MD         
UMC St Radboud Recruiting
Nijmegen, Netherlands, 6500HB
Contact: M. van Wely-Vertelman         
Principal Investigator: M. van Wely-Vertelman, MD         
Isala klinieken Recruiting
Zwolle, Netherlands
Contact: A.T.M. Gosselink, Dr.         
Principal Investigator: A.T.M. Gosselink, MD; PhD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
B. Braun Medical b.v.
Investigators
Principal Investigator: Jan Baan, Dr Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: J. Baan, J. Baan, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01127958     History of Changes
Other Study ID Numbers: NL3148701810
Study First Received: May 18, 2010
Last Updated: May 20, 2014
Health Authority: Medical Ethics Review Commitee (METC), Netherlands ':'

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
In-stent restenosis
Minimal lumen diameter
Drug eluting balloon
Drug eluting stent

ClinicalTrials.gov processed this record on November 20, 2014