The purpose of this study is to evaluate the safety and feasibility of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over time, leaving no permanent implant after the blood vessel has healed. This study will will be the first evaluation of this stent in humans.
The objective of this first-in-man study is to evaluate the safety and feasibility of the AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold for use in the treatment of single, de novo, stenotic native coronary artery lesions in patients undergoing elective percutaneous coronary intervention. The scaffold is a single-use device comprised of a balloon-expandable, intracoronary drug coated scaffold pre-mounted on a rapid-exchange delivery catheter. The scaffold is made of Poly-L-Lactide (PLLA) and is coated with a polymer-antiproliferative drug (sirolimus) matrix. The scaffold provides mechanical support similar to a metallic stent to the vessel while it is healing, and then gradually breaks down over time leaving no permanent implant in the treated vessel. The study design is a prospective, non-randomized, feasibility trial. It will enroll a maximum of 50 patients from multiple investigational centers in Columbia. Eligible patients who are at least 18 years of age diagnosed with symptomatic ischemic disease due to a discrete, single, de novo, stenotic lesion in native coronary artery will be asked to participate in this study. After treatment with the investigational device, subjects will be followed for five years. Safety of the device will be evaluated using the incidence of target vessel failure during the follow-up period. Efficacy will be assessed using the in-scaffold late lumen loss measured by quantitative coronary angiography at nine months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.
Clinica de Marly
Bogotá, Colombia
Instituto del Corazon
Bucaramanga, Colombia
Angiografia De Occidente S.A.
Cali, Colombia
EMMSA Clinica Especializada
Medellín, Colombia
Incidence of target vessel failure
Defined as the composite rate of cardiac death (using the Academic Research Consortium \[ARC\] definition), target vessel myocardial infarction (using the Third Universal Definition of MI), or clinically indicated target lesion revascularization (using the ARC definition).
Time frame: 9 months
In-scaffold late lumen loss
Defined as the amount of vessel lumen diameter (in mm) lost/gained at the time of follow-up compared to the immediate post-treatment result, as measured by quantitative coronary angiography (QCA). The assessment is made within the segment of vessel including the scaffold.
Time frame: 9 months
Clinical device success
Defined as successful delivery and deployment of the investigational scaffold at the intended target lesion with attainment of a final residual stenosis of \< 50% of the target lesion by quantitative coronary angiography (QCA) after the index procedure.
Time frame: intraoperative
Clinical procedure success
Defined as successful delivery and deployment of the investigational scaffold at the intended target lesion, with attainment of a final residual stenosis of \< 50% of the target lesion by quantitative coronary angiography (QCA) using any adjunctive device, without the occurrence of major adverse clinical events (cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization) during the duration of the subject's hospital stay (an average of 1-2 days).
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 1-2 days
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Enrollment
42