Coronary Artery Disease
Conditions
Keywords
Coronary artery disease
Brief summary
To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native coronary artery lesion designated the target lesion and up to one non-target lesion located in a separate epicardial vessel.
Interventions
DEVICEDESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
percutaneous coronary
Sponsors
Elixir Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be at least 18 years of age and for the 35-patient subset, patients must be over the age of 50 * Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve Nx Novolimus Eluting BCSS and he/she provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure * Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia) * Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery * Patient must agree to undergo all clinical study required follow-up visits, angiograms, and as applicable, IVUS, OCT, MSCT and coronary vasomotion testing * Patient must agree not to participate in any other clinical study for a period of two years following the index procedure Angiographic Inclusion Criteria: Target lesion must be located in a native coronary artery with a nominal vessel diameter of between 2.75 and 3.5 mm assessed by online QCA * Target lesion must measure ≤ 14 mm in length * Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 90% with a TIMI flow of ≥ 1 * Percutaneous intervention of lesions in the target vessel if: 1. Not part of a clinical investigation 2. ≥ 6 months prior to the study index procedure 3. ≥ 9 months after the study index procedure (planned) 4. Previous intervention was distal to and \>10mm from the target lesion
Exclusion criteria
* Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure * Patient is currently experiencing clinical symptoms consistent with AMI * Patient requires the use of any rotablator intervention during the index procedure * Patient has current unstable arrhythmias * Patient has a known 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 is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure * Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) * Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures. * Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Novolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated * Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel * Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease. * Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis) * Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions * Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months * Patient has had a significant GI or urinary bleed within the past six months * Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion * Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year) * Patient is already participating in another clinical study * Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing * Patient is unable to give their consent, is legally incompetent, or is institutionalized by virtue of an order issued by the courts or other authority Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss | 6 month | MLD post procedure - MLD at follow-up |
| Clinically-indicated major adverse cardiac events (MACE) | 6 months | cardiac death, target vessel MI, clinically indicated TLR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events | 1 month | cardiac death, target vessel MI, clinically indicated TLR |
| Clinically-Indicated Target Lesion Failure (TLF) | 1 month | cardiac death, MI, clinically indicated TLR |
| Clinically-Indicated Target Vessel Failure (TVF) | 1 year | cardiac death, MI, clinically indicated TVR |
| Scaffold Thrombosis | through 5 years | ARC defined |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acute success - Device success | 7 days | Acute Success is classified according to the following definitions: Device success - Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis \< 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met. |
| Acute success - Procedure success | 7 days | Acute Success is classified according to the following definitions: Procedure success - Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of \< 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. |
Countries
Belgium, Brazil, Denmark, Germany, New Zealand, Poland
Outcome results
None listed