This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS.
The LEADERS FREE IV trial is conducted to evaluate of the efficacy (QCA) and safety of the BioFreedom™ Ultra Drug Coated Stent in patients with High Bleeding Risk (HBR) and coronary artery disease undergoing Percutaneous Coronary Intervention. It is a prospective, multi-center, single blind (to patient), randomized, comparator trial, designed to randomize 444 HBR patients at approximately up to 7 centers in Malaysia. The primary objective is to confirm non-inferiority of the BioFreedom™ Ultra stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary objective is to assess safety as measured by TLF and ST. 444 patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed up to 5 years to measure for late TLF and ST events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
444
Stent implantation
Stent implantation
Hospital Sultanah Aminah
Johor Bahru, Johor, Malaysia
RECRUITINGHospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
RECRUITINGHospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
In-stent late lumen loss (LLL) at 9 months
In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months
Time frame: 9 months
All clinical events at protocol defined timepoints
* Cardiovascular Death * Myocardial infarction (according to the Fourth Universal Definition) * TLF (defined as cardiovascular death, target vessel related MI and clinically driven (cd) target lesion revascularization (TLR)) * All-cause mortality * Clinically driven TVR * Stent Thrombosis, per ARC-2 definition of definite/probable * Device success * Procedure success * Lesion success * Bleeding per BARC criteria * BARC 3 to 5 * All BARC * By vascular access site (Femoral/Radial)
Time frame: 1,6,9,12 months, 2 ,3, 4, 5 years
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Hospital Queen Elizabeth II
Kota Kinabalu, Sabah, Malaysia
RECRUITINGPusat Jantung Hospital Umum Sarawak
Kota Kinabalu, Sarawak, Malaysia
RECRUITINGHospital Serdang
Kajang, Selangor, Malaysia
RECRUITING