A prospective, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in a 2:1 ratio \[BioMime™ Morph (n=133) vs. XIENCE family (n=67)\]. The study population should include patients with symptomatic ischemic heart disease due to de novo lesions (lengths ≥26 mm and ≤56 mm irrespective of number of lesions) in native coronary arteries with a reference vessel diameter of (proximal to distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.5 - 3.00 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and stenting procedures. All patients must meet all the study inclusion / exclusion criteria before enrolment in the study. All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 24 months post procedure. 10% of the patients \[(2:1) BioMime™ Morph (13) vs. Xience (7)\] will be assessed for OCT analysis from pre-designated site(s) and based on availability of OCT console at the site and Patient's consent. \[Time Frame: Post-procedure and 6 months (±14 days)\]
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Approximately 200 patients will be randomly enrolled in a 2:1 ratio \[BioMime™ Morph (n=133) vs. XIENCE family (n=67)\].
Active Control Device :- Xience family Everolimus Coronary Stent Systems Approximately 200 patients will be randomly enrolled in a 2:1 ratio \[BioMime™ Morph (n=133) vs. XIENCE family (n=67)\].
Target Lesion Failure (TLF)
Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or Ischemia-driven target lesion revascularization.
Time frame: 6 months (±14 days)
Target Lesion Failure
Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or ischemia-driven target lesion revascularization.
Time frame: 1 month (± 7 days), 12 months (±1 month) and 24 months (±1 month)
MACE
Major adverse cardiac event is defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven Target Lesion Revascularization (ID-TLR).
Time frame: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Stent Thrombosis Rate (As per Academic Research Consortium)
Stent thrombosis is defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers, probable (any unexplained death within the first 30 days), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis is categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).
Time frame: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Ischemia-driven Target Vessel Revascularization (ID-TVR)
Ischemia-driven Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
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