| Eligibility |
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 Novolimus Eluting Bioresorbable Coronary
Scaffold System (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, imaging testing
- Patient must agree not to participate in any other clinical study for a period of two
years following the index procedure
- Target lesion must be located in a native coronary artery with a nominal vessel
- Not part of a clinical investigation
- Treatment of a single, non-target lesion located in a separate major epicardial vessel
Target vessel diameter must be a diameter of between 2.25 and 3.5 mm assessed by
online QCA
- Target lesion must measure = 24 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
- Target vessel must be in a major coronary artery or major branch
Exclusion Criteria:
- Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours
preceding the index procedure and cardiac enzymes 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
- Target lesion(s) meets any of the following criteria:
- Aorto-ostial location
- Left main location
- Located within 5 mm of the origin of the LAD or LCX
- Located within an arterial or saphenous vein graft or distal to a diseased arterial or
saphenous vein graft
- Lesion involving a side branch >2mm in diameter or bifurcation
- Previous placement of a scaffold proximal to or within 10 mm of the target lesion
- Total occlusion (TIMI flow 0), or TIMI flow < 1
- Excessive tortuosity proximal to or within the lesion
- Angulation (= 45o) proximal to or within the lesion
- Calcification moderate or heavy
- 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)
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