SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study (SEDUCE)
|ClinicalTrials.gov Identifier: NCT01065532|
Recruitment Status : Unknown
Verified April 2009 by University Hospital, Gasthuisberg.
Recruitment status was: Recruiting
First Posted : February 9, 2010
Last Update Posted : February 10, 2010
Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study.
A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT follow-up at 9 months.
|Condition or disease||Intervention/treatment||Phase|
|Restenosis||Device: Sequent Please Paclitaxel eluting balloon Device: Xience V everolimus eluting stent||Not Applicable|
Background: The optimal treatment of bare metal stent restenosis (implantation of a drug-eluting stent, simple balloon dilatation, CABG) is still not defined. The most used option nowadays is the implantation of a drug-eluting stent (DES). However, this procedure implies application of a double metal layer in the vessel wall, which is linked to delayed healing. Furthermore there might be a higher risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stents. These phenomenon's might give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) were proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising.
Aim: To compare healing processes after treatment of BMS ISR with balloon dilatation using DEB versus implantation of DES.
Methods: 50 patients with BMS restenosis (SVG and bifurcation lesions will be excluded) will be randomized into two treatment groups: SeQuent Please drug-eluting balloon dilatation (group I) versus implantation of an everolimus-eluting Xience V stent (group II). At 9 months, a control angiography with OCT pullback of the treated segment is planned.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Healing Responses After Treatment of Bare Metal Stent Restenosis With Implantation of an Everolimus-eluting Xience V Stent Versus Use of a Paclitaxel-eluting Balloon: Optical Coherence Tomography Study|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2015|
Active Comparator: 1
SeQuent Please Drug-eluting balloon
Device: Sequent Please Paclitaxel eluting balloon
Sequent Please Paclitaxel eluting balloon
Active Comparator: 2
Xience V Drug-eluting stent
Device: Xience V everolimus eluting stent
Xience V everolimus eluting stent
- Stent strut coverage and stent strut apposition(assessed with OCT) [ Time Frame: 9 months ]
- Lumen Loss (in-stent) at 9 months In-segment Late Lumen Loss at 9 months Cumulative MACE rate at 9 months Stent thrombosis at all follow-ups Target vessel revascularisation (TVR) at 12 months Device success [ Time Frame: 9 months, 12 months, yearly until 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065532
|Contact: Tom Adriaenssens, MD||+32 16 34 24 firstname.lastname@example.org|
|Contact: Walter Desmet, MD, PhD||+32 16 34 24 email@example.com|
|University Hospitals Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Tom Adriaenssens, MD +32 16 34 24 65 firstname.lastname@example.org|
|Contact: Walter Desmet, MD, PhD +32 16 34 24 65 email@example.com|
|Principal Investigator: Tom Adriaenssens, MD|
|Sub-Investigator: Walter Desmet, MD, PhD|
|Sub-Investigator: Christophe Dubois, MD|
|Principal Investigator:||Tom Adriaenssens, MD||UZ Leuven|
|Study Director:||Walter Desmet, MD, PhD||UZ Leuven|