SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Restenosis

Treatments: Device: Sequent Please Paclitaxel eluting balloon; Device: Xience V everolimus eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01065532

EudraCT 2009-011440-20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient older than 18 years
2. written informed consent available
3. patient eligible for percutaneous coronary intervention
4. patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether BMS or DES)
5. Target reference vessel diameter measured by QCA: 2-4 mm
6. Target lesion length measured by QCA < 24 mm
7. Target lesion stenosis measured by QCA: > 70%- < 100%
8. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.

Exclusion criteria

1. Left ventricular ejection fraction of < 30%
2. Impaired renal function (serum creatinine > 2.0 mg/dl)
3. Target lesion located in bifurcation
4. Previous and/or planned brachytherapy of target vessel
5. Lesion of the left main trunk > 50%, unprotected
6. Known allergies to antiplatelet, anticoagulation therapy, contrast media, paclitaxel or everolimus
7. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
8. Patients with a life expectancy of less than one year
9. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
10. Patient currently enrolled in other investigational device or drug trial
11. Patient not able or willing to adhere to follow-up visits
12. Patients who previously participated in this study. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

SeQuent Please Drug-eluting balloon

Treatment:

Device: Sequent Please Paclitaxel eluting balloon

2

Active Comparator group

Description:

Xience V Drug-eluting stent

Treatment:

Device: Xience V everolimus eluting stent