The purpose of this study is to assess whether the new Kaname coronary stent is safe and effective for the treatment of patients with coronary artery disease.
Current treatments for coronary artery disease include conservative treatment (drug therapies) and invasive techniques that help increase blood flow to ischemic or oxygen-deprived regions of the heart. Among the invasive techniques the most frequently used are coronary artery bypass graft surgery (CABG), and percutaneous transluminal coronary angioplasty (PTCA) without or with stents (bare metal stents (BMS) or drug eluting stents (DES)) implantation. However, all of those treatments have limitations and their effectiveness is diminished under certain circumstances. Therefore, it is essential to tailor therapy for each individual patient considering the overall patient's condition, disease severity and progression as well as concomitant diseases. The question of selection of appropriate stent for each individual patient is still unresolved and most of the physicians either follow international or national guidelines or scientific wisdom. Although the efficacy of DES is undisputable in restenosis prevention, because some patients could have adverse outcomes from a DES, they should be used selectively in those who are most likely to benefit, and in that decision process several important issues should be addressed such as:Patients' adherence to post-stenting therapy, Bleeding risk, Need for elective surgery, Risk for restenosis, Risk for stent thrombosis. It is still believed that many patients will do well with BMSs and that this technology requires further refinements to improve outcome. For the above reasons Terumo has designed the new coronary BMS, Kaname™, a balloon expandable Cobalt-Chromium (CoCr) stent pre-mounted onto a high pressure, semi-compliant balloon on a rapid exchange delivery catheter. The Kaname stent is the subject of the current prospective, multi-centre KARE study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
282
implantation of Kaname Cobalt-Chromium coronary stent
Hopital Cardiovasculaire et Pneumologie Louis Pradel
Lyon, France
CHU NORD
Nantes, France
Clinique les Franciscaines
Nîmes, France
Freedom from Target vessel failure TVF
Freedom from Target vessel failure TVF defined as composite of clinically driven target vessel revascularization (TVR)myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
Time frame: 6 months post-procedure
Freedom from TVF for patients treated with ≥ 3 mm stents.
Freedom from Target Vessel Failure (composite of clinically driven TVR, myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel) for patients treated with ≥ 3 mm stents.
Time frame: 6 months post-procedure
Freedom from TVF for patients treated with 2.5 and 2.75 mm stents
Freedom from Target Vessel Failure (composite of clinically driven TVR, myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel) for patients treated with 2.5 and 2.75 mm stents
Time frame: 6 months post-procedure
Freedom from TVF
Freedom from Target Vessel Failure (composite of clinically driven TVR, myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel)
Time frame: 30 days,12 months and 3 and 5 years post-procedure
Clinically driven target lesion revascularization (TLR) free rate .
Clinically driven target lesion revascularization (TLR) free rate
Time frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Clinically driven target vessel revascularization (TVR) free rate.
Clinically driven target vessel revascularization (TVR) free rate.
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Hopital d'Instructions des Armées du Val de Grace
Paris, France
CHU Rangeuil
Toulouse, France
Klinikum Fulda gAG
Fulda, Germany
Klinikum Ludwigshafen
Ludwigshafen, Germany
Klinikum des Johannes Gutenberg Universität
Mainz, Germany
Ospedale Careggi
Florence, Italy
Policlinico Milano
Milan, Italy
...and 7 more locations
Time frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Device success
Device success defined as achievement of a residual diameter stenosis of \< 50% by QCA or \< 30% by visual estimate, using the assigned device only.
Time frame: Baseline procedure
Lesion success
Lesion success defined as the attainment of residual diameter stenosis of \< 50% by QCA or \< 30% by visual estimate, using any percutaneous method.
Time frame: Baseline procedure
Procedure success
Procedure success defined as achievement of a final diameter stenosis of \< 50% by QCA or \< 30% by visual estimate, using any percutaneous method, without MACE (composite of cardiac death, MI and TLR) .
Time frame: During baseline hospital stay
Angiographic in-stent acute gain
Angiographic in-stent acute gain at the end of the procedure
Time frame: Baseline procedure
Angiographic in-stent and in-segment binary restenosis rate (≥ 50%) diameter stenosis
Angiographic in-stent and in-segment binary restenosis rate (≥ 50%) diameter stenosis
Time frame: 6 months post-procedure
Angiographic in-stent, in-segment, proximal, and distal minimum lumen diameter (MLD)
Angiographic in-stent, in-segment, proximal, and distal minimum lumen diameter (MLD)
Time frame: 6 months post-procedure
In-stent late-loss
In-stent late-loss (as measured by QCA) defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up MLD.
Time frame: 6 months post-procedure
% Diameter Stenosis, in-stent and in-segment .
% Diameter Stenosis, in-stent and in-segment.
Time frame: 6 months post-procedure
Neointimal hyperplasia volume as measured by intravascular ultrasound.
Neointimal hyperplasia volume as measured by intravascular ultrasound at 6 months post-procedure
Time frame: 6 months post-procedure
Major adverse cardiac events (MACEs) rate .
Major adverse cardiac events (MACEs: composite of cardiac death,, myocardial infarction and TLR) rate.
Time frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Serious adverse event rate .
Serious adverse event rate.
Time frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Device failure .
Any device failure
Time frame: Baseline procedure