Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - European Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Amaranth Medical Inc.
- Enrollment
- 21
- Locations
- 5
- Primary Endpoint
- In-scaffold late lumen loss
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and performance 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.
Detailed Description
The objective of this study is to evaluate the safety and performance 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, multi-center, non-inferiority trial. It will enroll a maximum of 120 patients from up to 10 investigational centers in the European Union. 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. Performance (efficacy) will be assessed using the in-scaffold late lumen loss measured by quantitative coronary angiography at nine months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is ≥ 18 years of age and \< 85 years of age.
- •Subject agrees not to participate in any other investigational device or drug study for a period of two years following the index procedure. Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed.
- •Subject (or their legally authorized representative) provides written informed consent prior to any study-related procedure, using the form approved by the local Ethics Committee.
- •Subject has:
- •evidence of myocardial ischemia (e.g., stable angina \[Canadian Cardiovascular Society 1, 2, 3, or 4\] or unstable angina \[Braunwald Class 1-3, B-C\], or silent ischemia with supporting imaging studies \[ETT, SPECT, stress echocardiography, or Cardiac CT\]), or
- •low or intermediate risk NSTEMI, or
- •evidence of myocardial ischemia in a coronary territory previously affected by STEMI as long as the lesion fulfills the angiographic inclusion criteria and the intervention performed ≥ 6 months following the clinical event.
- •Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- •Patient agrees to complete all protocol required follow-up visits, including angiograms.
- •Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or planned to be done ≥ 9 months after the index procedure.
Exclusion Criteria
- •Patient has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, and ticagrelor), sirolimus or its derivatives, poly (L-lactide), poly (D,L-lactide), platinum-iridium, or contrast sensitivity that cannot be adequately pre-medicated.
- •Patient has evolving ST segment elevation myocardial infarction (STEMI).
- •Patient has current unstable arrhythmias.
- •Patient has a left ventricular ejection fraction (LVEF) \< 30%.
- •Patient has received a heart transplant or any other organ transplant, or is on a waiting list for any organ transplant.
- •Patient has any previous stent placements ≤ 15 mm (proximal or distal) of the target lesion.
- •Patient is receiving or scheduled to receive chemotherapy for malignancy ≤ 30 days prior to or after the index procedure.
- •Patient is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).
- •Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, Coumadin) that cannot be stopped and restarted according to local hospital standard procedures.
- •Elective surgery is planned ≤ 9 months after the index procedure that will require discontinuation of anti-platelet medications.
Outcomes
Primary Outcomes
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.
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).
Secondary Outcomes
- Clinical procedure success(Participants will be followed for the duration of their hospital stay, an expected average of 1-2 days)
- Clinical device success(intraoperative)
- Vessel patency(2 years)