Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent (MEND II)
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|ClinicalTrials.gov Identifier: NCT02189499|
Recruitment Status : Unknown
Verified June 2016 by Amaranth Medical Inc..
Recruitment status was: Active, not recruiting
First Posted : July 14, 2014
Last Update Posted : June 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Ischemia||Device: AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Amaranth Endovascular Study of a Drug-Eluting Bioresorbable Coronary Scaffold|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||November 2020|
Experimental: Coronary Scaffold Implantation
AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Device: AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.
Other Name: Coronary stent
- Incidence of target vessel failure [ Time Frame: 9 months ]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).
- In-scaffold late lumen loss [ Time Frame: 9 months ]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.
- Clinical device success [ Time Frame: intraoperative ]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.
- Clinical procedure success [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1-2 days ]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).
- In-segment/in-scaffold late lumen loss [ Time Frame: 9 months and 2 years ]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; the assessment is made both within the scaffold itself ("in-scaffold") and within the segment of vessel including the scaffold and 5 mm proximal and distal to the scaffold ("in-segment").
- In-scaffold percent volume obstruction [ Time Frame: 9 months and 2 years ]Defined as the difference between the volume enclosed within the scaffold and the corresponding vessel lumen, expressed as a percentage of the scaffold volume at the time of follow-up, measured using optical coherence tomography (OCT)
- Stent thrombosis [ Time Frame: Hospital discharge, 30 days, 9 months, and 2 years ]Defined using the ARC "definite" or "probable" stent thrombosis definitions.
- In-scaffold/in-segment binary restenosis rate [ Time Frame: 9 months and 2 years ]Defined as the percentage of treated coronary lesions with a residual diameter stenosis over 50% at the time of follow-up, as measured by quantitative coronary angiography (QCA). The assessments are made both within the scaffold itself ("in-scaffold") and within the segment of vessel including the scaffold and 5 mm proximal and distal to the scaffold ("in-segment").
- Incomplete scaffold strut apposition to the vessel wall [ Time Frame: 9 months and 2 years ]Defined as the number (or percentage) of scaffold struts not in direct contact with the vessel wall, either persisting from the implantation of the scaffold or newly occurring after the time of scaffold implantation, assessed at follow-up using OCT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189499
|Clinica de Marly|
|Instituto del Corazon|
|Angiografia De Occidente S.A.|
|EMMSA Clinica Especializada|
|Principal Investigator:||Juan F Granada, MD||Skirball Center for Cardiovascular Research, Columbia University Medical Center|