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: 10011082
in-stent restenosis
stenosis of earlier implanted stent

Registration Number: NL-OMON34621

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 270

Inclusion Criteria

Restenosis of initially stented coronary artery
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
Amendable to PCI treatment with either the SeQuent Please DEB or the Xience Prime DES

Exclusion Criteria

The impossibility to arrange a follow-up coronary angiography at 6 months (± 1 month) after baseline procedure
Life expectancy less than one year
In-stent re-restenosis already treated with a second stent
Requirement for PCI in the same vessel or expected in the next 6 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to determine whether PCI with the<br /><br>SeQuent ® Please DEB versus PCI with the Xience* Prime DES for the treatment of<br /><br>patients with in-stent restenosis is non-inferior with respect to minimal lumen<br /><br>diameter (MLD) assessed by quantitative coronary angiography (QCA) at six<br /><br>months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are the following parameters:In-stent and<br /><br>in-segment percent Diameter Stenosis (% DS) at 6 months, in-stent and<br /><br>in-segment Angiographic Binary Restenosis (ABR) rate at 6 months, aneurysm,<br /><br>thrombosis and persisting dissection (i.e. dissection post-index-procedure that<br /><br>remained present at follow-up) at 6 months, cardiac death, myocardial<br /><br>infarction, unless originating from a un-treated vessel, target vessel<br /><br>re-vascularization, either by PCI or CABG, stent thrombosis, ischemia driven<br /><br>target vessel re-stenosis, not amenable to re-vascularization.</p><br>