Condition category
Circulatory System
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
08/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ncn.fr/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes