The purpose of this study is to evaluate the safety and performance of a new version of a coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth Medical MAGNITUDE 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.
The objective of this study is to evaluate the safety and performance of the AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold for use in the treatment of up to two different de novo 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. Compared to prior versions of the scaffold, the new device has a thinner strut design (a wall thickness of 100 µm rather than 120 µm or 150 µm), but is otherwise identical. The study design is a prospective, non-randomized, multi-center, non-inferiority trial. It will enroll a maximum of 70 patients from up to 20 investigational centers in Colombia and the European Union. Eligible patients who are at least 18 years of age diagnosed with symptomatic ischemic disease due to up to two different, de novo, stenotic lesions in native coronary arteries 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. Performance (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
Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.
Clinica de Marly
Bogotá, Colombia
NOT_YET_RECRUITINGInstituto del Corazon
Bucaramanga, Colombia
RECRUITINGIn-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 containing the scaffold.
Time frame: 9 months
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 Expert Consensus Document from the Society for Cardiovascular Angiography and Interventions), or clinically indicated target lesion revascularization (using the ARC definition).
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; calculated on a per lesion basis.
Time frame: intraoperative
Clinical procedure success
Defined as successful delivery and deployment of the investigational scaffold at the intended target lesion(s), 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); calculated on a per patient basis.
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 1-2 days
Vessel patency
Assessed both by the minimum lumen diameter (MLD) and percent diameter stenosis (%DS), each measured at 2 years by either coronary computed tomography angiography (CTA) or quantitative coronary angiography (QCA).
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NONE
Enrollment
70
Angiografia De Occidente S.A.
Cali, Colombia
RECRUITINGEMMSA Clinica Especializada
Medellín, Colombia
RECRUITINGAzienda Policlinico-Vittorio Emanuele, Universita di Catania
Catania, Italy
NOT_YET_RECRUITINGAzienda Ospedaliero Universitaria Careggi
Florence, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Fatebenefratelli e Oftalmico
Milan, Italy
NOT_YET_RECRUITINGIRCCS Instituto Clinico Humanitas
Milan, Italy
NOT_YET_RECRUITINGOspedale San Raffaele
Milan, Italy
NOT_YET_RECRUITINGPoliclinico San Donato
Milan, Italy
NOT_YET_RECRUITING...and 3 more locations
Time frame: 2 years