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.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR883
• Date of registration: 30/01/2007
• Primary sponsor: Nouvelles Cliniques Nantaises Unité de soins et de cardiologie interventionnelle
• Public title: 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.
• Scientific title: 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. - LIBERTY ONE
• Date of first enrolment: 1/2/2007
• Target sample size: 400
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=883
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: Luc Verhees

• Name: Phillipe Brunel

Key inclusion & exclusion criteria

Inclusion criteria: 1. 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 criteria: 1. 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Coronary lesions

Intervention(s)

PCI, provisional side branch T-stenting

Primary Outcome(s)

Target Lesion Revascularization of the Main Branch and Side Branch defined by the independent core lab at 9 months follow-up.

Secondary Outcome(s)

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 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.

Secondary ID(s)

ISRCTN82823121

N/A

Source(s) of Monetary Support

Boston Scientific