elixir medical clinical evaluation of the desolve® novolimus eluting bioresorbable coronary scaffold system - the desolve nx trial

Conditions: Coronary Artery Disease

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.


Eligibility criteria:
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 \ 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 exclusion criteria * target lesion(s) meets any of the following criteria: 1. aorto-ostial location 2. left main location 3. located within 5 mm of the origin of the lad or lcx 4. located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft 5. lesion involving a side branch \>2mm in diameter or bifurcation 6. previous placement of a scaffold proximal to or within 10 mm of the target lesion 7. total occlusion (timi flow 0), or timi flow \< 1 8. excessive tortuosity proximal to or within the lesion 9. angulation (≥ 45o) proximal to or within the lesion 10. calcification moderate or heavy 11. previous intervention restenosis * the target vessel contains visible thrombus * another clinically significant lesion (\>40%) is located in the same major epicardial vessel as the target lesion * patient has a high probability that a procedure other than pre-dilatation and scaffolding and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

Keywords: coronary artery disease