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van CCT (UK)


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van CCT (UK)


An international, multicenter prospective single arm study to investigate procedural, clinical and angiographic outcomes using the Taxus Liberte stent, with improved side branch access, following the provisional side branch T-stenting approach, in patients with complex lesions.


- candidate number2440
- NTR NumberNTR883
- ISRCTNISRCTN82823121
- Date ISRCTN created8-feb-2007
- date ISRCTN requested7-feb-2007
- Date Registered NTR30-jan-2007
- Secondary IDsN/A 
- Public TitleAn international, multicenter prospective single arm study to investigate procedural, clinical and angiographic outcomes using the Taxus Liberte stent, with improved side branch access, following the provisional side branch T-stenting approach, in patients with complex lesions.
- Scientific TitleAn international, multicenter prospective single arm study to investigate procedural, clinical and angiographic outcomes using the Taxus Liberte stent, with improved side branch access, following the provisional side branch T-stenting approach, in patients with complex lesions.
- ACRONYMLIBERTY ONE
- hypothesisThe purpose of the Liberté One study is to assess procedural, clinical and angiographic outcomes of the provisional T-stenting approach with the Taxus Liberte stent implanted in complex lesions (with side branch involvement). The Taxus Liberte stent has larger cell perimeters and as such an improved side branch access.
- Healt Condition(s) or Problem(s) studiedCoronary lesions
- Inclusion criteria1. Patients with stable angina pectoris (CCSC1234) or unstable angina and documented ischemia or silent ischemia; 2. Patient eligible for coronary revascularisation; 3. The target lesion has a major native coronary artery (>2.5mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2mm); 4. A de novo lesion; 5. All angle severities (between branches) accepted; 6. The main vessel lesion can be covered by one stent (up to 32mm); 7. Other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis <30%, stent well deployed, no residual dissection, normal TIMI flow, no chest pain, ECG unchanged compared to pre-procedural ECG; 8. Only one target lesion can be included in the study; 9. Signed patients informed consent.
- Exclusion criteria1. Patients with in stent restenosis of target lesion; 2. Severe calcifications with an undilatable lesion during balloon predilatation (PTRA could be considered); 3. History of bleeding diathesis; 4. Untreated significant lesion greater than 50% diameter stenosis remaining proximal or distal to the target intervention; 5. Patient has suffered a stroke or TIA within the past 6 months; 6. Known untreatable malignancy; 7. Any major surgery planned or required during the next 9 months; 8. Acute Myocardial Infarction; 9. Allergy to contrast and/or required antiplatelet medication; 10. Left Main coronary artery.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-feb-2007
- planned closingdate31-aug-2008
- Target number of participants400
- InterventionsPCI, provisional side branch T-stenting
- Primary outcomeTarget Lesion Revascularization of the Main Branch and Side Branch defined by the independent core lab at 9 months follow-up.
- Secondary outcome1. Incidence of Major Adverse Cardiac Events (MACE) defined as all Cardiac Deaths, Q-wave and non-Q wave Myocardial Infarction, Target Lesion Revascularisation (defined as both the main and the side branch) including PTCA and CABG at 1, 7, 9 and 12 months follow-up. 2. Acute success rate of stent delivery, recross, and final kissing balloon dilatation, and the number of a second stent implanted on the side branch. 3. Restenosis will be evaluated by compulsory 9 months angiogram using the binary definition (greater than 50% in diameter) in the main and the side branch vessel. Measure of the absolute lumen diameter before, immediately after and at 9 months reflecting the net gain, difference of acute gain and late loss. Late loss ratio and late loss index. Additional usual and lesion specific (main and side branch) quantitative results will be analyzed. 4. Target Lesion and Target Vessel Revascularisation of the Main and Side branch separately at 7, 9 and 12 months follow-up.
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Luc Verhees
- CONTACT for SCIENTIFIC QUERIESDr. Phillipe Brunel
- Sponsor/Initiator Nouvelles Cliniques Nantaises Unité de soins et de cardiologie interventionnelle
- Funding
(Source(s) of Monetary or Material Support)
Boston Scientific
- Publications
- Brief summaryStented coronary arteries are prone to renarrowing. This may occur in up to 40% of cases at a complex lesions (with side branch involvement). Various techniques are used in treating coronary bifurcation narrowings, inflating balloons, T-stenting,V-stenting,Y-stenting, crush and culotte. These techniques use either one, two or even three stents. The simplest approach is provisional T-stenting. None of these treatments have shown significate superiority.Provisional T-stenting has reported good results with bare metal stents, and is considered to be the "gold standard" technique with this technology. The TAXUS stent is a drug-eluting stent, and this study will establish whether it can be used safely and efficaciously at complex lesions (with side branch involvement), using the stepwise provisional T-stenting techniqe.
- Main changes (audit trail)
- RECORD30-jan-2007 - 9-feb-2007


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