An international, multicentre 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

ISRCTN	ISRCTN82823121
DOI	https://doi.org/10.1186/ISRCTN82823121
Secondary identifying numbers	N/A

Submission date: 08/02/2007
Registration date: 08/02/2007
Last edited: 08/02/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Luc Verhees
Scientific

Boston Scientific
Gaetano Martinolaan 50
Maastricht
6201 BJ
Netherlands

Email	luc.Verhees@bsci.com

Study information

Study design	International, multicentre prospective single arm study
Primary study design	Interventional
Secondary study design	Multi-centre
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	LIBERTY ONE
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Coronary lesions
Intervention	Percutaneous Coronary Intervention (PCI), provisional side branch T-stenting.
Intervention type	Other
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 study start date	01/02/2007
Completion date	31/08/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	400
Key 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
Key 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
Date of first enrolment	01/02/2007
Date of final enrolment	31/08/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Boston Scientific

Maastricht
6201 BJ
Netherlands

Sponsor information

New Nantes Private Clinics (Nouvelles Cliniques Nantaises) (France)
Hospital/treatment centre

Unit of Care and Interventional Cardiology (UnitÉ de soins et de cardiologie interventionnelle)
4, rue Eric Tabarly
Nantes
44277
France

Email	brunel-phiippe@wanadoo.fr
Website	http://www.ncn.fr/
"ROR"	https://ror.org/03731ze76

Funders

Funder type

Industry

Boston Scientific (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan