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.

In-stent Restenosis Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01127958
• Other study ID #: NL3148701810
• Status: Active, not recruiting
• Phase: N/A
• First received: May 18, 2010
• Last updated: February 16, 2017
• Start date: May 2010
• Est. completion date: June 2020

Study information

• Verified date: February 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• In-stent Restenosis

Intervention

Device:
• PCI with a drug-eluting balloon
PCI with a drug-eluting balloon for in-stent restenosis
• PCI with a drug-eluting stent
PCI with a drug-eluting stent for in-stent restenosis

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	OLVG	Amsterdam
Netherlands	VUmc	Amsterdam
Netherlands	Tergooi Ziekenhuizen	Blaricum
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Albert Schweitzer ziekenhuis	Dordrecht
Netherlands	UMC St Radboud	Nijmegen
Netherlands	Isala klinieken	Zwolle

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	B. Braun Medical B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

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