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Obseravtional study evaluating the perfomance of the bioabsorbable stent (scaffold) in every day clinical practice


- candidate number15194
- NTR NumberNTR4090
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2013
- Secondary IDs2012-594 MEC
- Public TitleObseravtional study evaluating the perfomance of the bioabsorbable stent (scaffold) in every day clinical practice
- Scientific TitleBioresorbable vascular Scaffold Expanding the experience to the daily practice of interventional cardiology
- ACRONYMBVS Expand
- hypothesisNo hypothesis, this study evaluates the long term safety and performance of the BVS coronary stent, in routine clinical practice. Its objective is to measure the incidence of Major Adverse Cardiac Events (MACE) patients with NSTEMI, stable or unstable angina, or silent ischemia.
- Healt Condition(s) or Problem(s) studiedCoronary artery disease, PCI, Bioabsorbable stent (scaffold)
- Inclusion criteria1. Patient presenting with NSTEMI stable or unstable angina , or silent ischemia caused by a de novo stenotic lesion in a native previous untreated coronary artery.
2. Dmax (proximal and distal mean lumen diameter) within the upper limit of 3.8 mm and the lower limit of 2.0 mm by online QCA (at the moment only for the 2.5 mm and 3.5 mm devices)
- Exclusion criteria1. Previous CABG
2. Cardiogenic shock
3. STEMI patients requiring immediate stent implantation
4. Bifurcation lesion requiring kissing ballon postdilatation
5. Allergies or contraindications to antiplatelet medication
6. Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
7. Expected survival of < 1year
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2012
- planned closingdate31-dec-2018
- Target number of participants300
- InterventionsPCI with bioabsorbable scaffold
- Primary outcomeMajor Adverse Cardiac Events (MACE): defined as cardiac death, re-MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 12 months post-procedure
- Secondary outcome1. Major Adverse Cardiac Events (MACE): defined as cardiac death, re-MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods 30 days, 6, 12, 18 months, 2, 3, 4, and 5 years post-procedure 2. Target vessel failure (TVF) defined as cardiac death, target vessel myocardial infarction (MI) [Q or Non Q-Wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods at 30 days, 6, 12, 18 months, 2, 4 and 5 years. 3. Health Related Quality-of-Life (HRQL) at 30 days, 6, 12 months, 3 and 5 years 4. Success Rates: a) Device Success: Attainment of <30% final residual stenosis of the segment of the culprit lesion covered by the BVS, by visual estimation b) Procedure Success: Device success and no peri-procedural complications c) Clinical success: Procedural success and no in-hospital MACE 5. Reperfusion measured by: TIMI Flow: TIMI flow at the end of the procedure 6. Incidence of stroke at 30 days, 6, 12, 18 months, 2, 3, 4, and 5 years 7. Stent thrombosis at 30 days, 6, 12, 18 months, 2, 3, 4, and 5 years 8. Vessel geometry of treated segments at 18 months FU MSCT
- TimepointsFollow-up scheduled at 30 days, 6, 12, 18 month, and at 2,3,4,5 years
- Trial web siteeCRF only
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A. Ruiter
- CONTACT for SCIENTIFIC QUERIESDr. R.J. Geuns, van
- Sponsor/Initiator Investigator initiated trial ( IIT )
- Funding
(Source(s) of Monetary or Material Support)
Abbott
- PublicationsN/A
- Brief summaryEvaluation of the long term safety and performance of the BVS coronary stent in routine clinical practice. Its objective is to measure the incidence of Major Adverse Cardiac Events (MACE) patients with NSTEMI, stable or unstable angina, or silent ischemia.
- Main changes (audit trail)
- RECORD2-aug-2013 - 5-aug-2013


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