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

Restenosis Clinical Trial

— SEDUCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065532
• Other study ID #: EudraCT 2009-011440-20
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: December 2016

Study information

• Verified date: October 2018
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Restenosis

Intervention

Device:
• Sequent Please Paclitaxel eluting balloon
Sequent Please Paclitaxel eluting balloon
• Xience V everolimus eluting stent
Xience V everolimus eluting stent

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent strut coverage and stent strut apposition(assessed with OCT)		9 months
Secondary	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		9 months, 12 months, yearly until 5 years