Restenosis Clinical Trial
— SEDUCEOfficial 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
Verified date | October 2018 |
Source | Universitaire Ziekenhuizen KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. - |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
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 |
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