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.
|ClinicalTrials.gov Identifier: NCT01127958|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2010
Last Update Posted : February 17, 2017
|Condition or disease||Intervention/treatment|
|In-stent Restenosis||Device: PCI with a drug-eluting balloon Device: PCI with a drug-eluting stent|
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.
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.
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.
PCI with a drug-eluting stent, or PCI with a drug-eluting balloon.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||May 2010|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
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
- 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.
- In-stent and in-segment percent Diameter Stenosis [ Time Frame: 6 months ]
- In-stent and in-segment Angiographic binary restenosis [ Time Frame: 6 months ]
- Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127958
|Academisch Medisch Centrum|
|Amsterdam, Netherlands, 1105AZ|
|Albert Schweitzer ziekenhuis|
|Dordrecht, Netherlands, 3300AK|
|UMC St Radboud|
|Nijmegen, Netherlands, 6500HB|
|Principal Investigator:||Jan Baan, Dr||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|