Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent (MEND II)
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.
Coronary Artery Disease
Device: AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Amaranth Endovascular Study of a Drug-Eluting Bioresorbable Coronary Scaffold|
- Incidence of target vessel failure [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]Defined as 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 ] [ Designated as safety issue: No ]Measured using quantitative coronary angiography (QCA).
- Clinical device success [ Time Frame: End of index procedure ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Defined using the ARC "definite" or "probable" stent thrombosis definitions.
- Binary restenosis rate [ Time Frame: 9 months and 2 years ] [ Designated as safety issue: No ]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.
- Incomplete scaffold strut apposition to the vessel wall [ Time Frame: 9 months and 2 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||January 2020|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02189499
|Contact: Andrew J Ford, Jr., BS||+1 650 965 3830 ext firstname.lastname@example.org|
|Clinica Marly||Not yet recruiting|
|Clinica San Rafael||Not yet recruiting|
|Instituto del Corazon||Not yet recruiting|
|Centro Cardiovascular Colombiano Clinica Santa Maria (Cardiovid)||Not yet recruiting|
|EMMSA Clinica Especializada||Not yet recruiting|
|Principal Investigator:||Juan F Granada, MD||Skirball Center for Cardiovascular Research, Columbia University Medical Center|