To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Sabah Heart Centre, Queen Elizabeth Hospital II
Kota Kinabalu, Malaysia
National Heart Institute
Kuala Lumpur, Malaysia
Cardio Vascular Sentral
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
late lumen loss in-segment
angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline
Time frame: 6 months
Procedural success
combined endpoint of: \< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE
Time frame: 5 days
MACE
combined endpoint of: cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months
Time frame: at 6 and at 12 months
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Sarawak Heart Centre
Kuching, Malaysia
Hospital Pulau Pinang
Pulau Pinang, Malaysia