Contact information
Type
Scientific
Primary contact
Dr Luc Verhees
ORCID ID
Contact details
Boston Scientific
Gaetano Martinolaan 50
Maastricht
6201 BJ
Netherlands
luc.Verhees@bsci.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LIBERTY ONE
Study hypothesis
The 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.
Ethics approval
Not provided at time of registration
Study design
International, multicentre prospective single arm study
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Coronary lesions
Intervention
Percutaneous Coronary Intervention (PCI), provisional side branch T-stenting.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Target lesion revascularisation of the main branch and side branch defined by the independent core lab at nine months follow-up.
Secondary outcome measures
1. 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 Percutaneous Transluminal Coronary Angioplasty (PTCA) and Coronary-Artery Bypass Grafting (CABG) at one, seven, nine 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 nine 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 will occur before, immediately after and at nine months, reflecting the net gain, difference of acute gain and late loss ratio and late loss index. Additional usual and lesion specific (main and side branch) quantitative results will be analysed
4. Target lesion and target vessel revascularisation of the main and side branch separately at seven, nine and 12 months follow-up
Overall trial start date
01/02/2007
Overall trial end date
31/08/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with stable angina pectoris (CCSC1234) or unstable angina and documented ischaemia or silent ischaemia
2. Patient eligible for coronary revascularisation
3. The target lesion has a major native coronary artery (more than 2.5 mm) with a stenosis more than 50% (on visual assessment) located at a side branch (more than 2 mm)
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 32 mm)
7. Other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis less than 30%, stent well deployed, no residual dissection, normal Thrombolysis in Myocardial Infarction [TIMI] flow, no chest pain, ElectroCardioGram [ECG] unchanged compared to pre-procedural ECG)
8. Only one target lesion can be included in the study
9. Signed patients informed consent
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
1. Patients with in stent restenosis of target lesion
2. Severe calcifications with an undilatable lesion during balloon predilatation (Percutaneous Transluminal Renal Angioplasty [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 Transient Ischaemic Attack (TIA) within the past six months
6. Known untreatable malignancy
7. Any major surgery planned or required during the next nine months
8. Acute myocardial infarction
9. Allergy to contrast and/or required antiplatelet medication
10. Left main coronary artery
Recruitment start date
01/02/2007
Recruitment end date
31/08/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Boston Scientific
Maastricht
6201 BJ
Netherlands
Sponsor information
Organisation
New Nantes Private Clinics (Nouvelles Cliniques Nantaises) (France)
Sponsor details
Unit of Care and Interventional Cardiology (UnitÉ de soins et de cardiologie interventionnelle)
4
rue Eric Tabarly
Nantes
44277
France
brunel-phiippe@wanadoo.fr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Boston Scientific (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list