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

Completed

• Conditions: Coronary lesions; Circulatory System; Lesions

• Registration Number: ISRCTN82823121
• Lead Sponsor: ew Nantes Private Clinics (Nouvelles Cliniques Nantaises) (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion revascularisation of the main branch and side branch defined by the independent core lab at nine months follow-up.