Evaluation of a Thin Strut Metallic Stent: the Elixir DynamX Clinical Study
Evaluation of a Thin Strut Metallic Stent: the Elixir DynamX Clinical Study
The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to
 enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length
 located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter. All patients be followed clinically at
 30 days, 6 and 9 months, and 1, 2 and 3 years.

 All patients will undergo imaging (angiography and IVUS) follow-up with approximately
 one-half of the patients returning for follow up at 9 months and approximately one-half
 returning for follow up at 12 months.
The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to
 enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length
 located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter. All patients be followed clinically at
 30 days, 6 and 9 months, and 1, 2 and 3 years.

 All patients will undergo imaging (angiography and IVUS) follow-up with approximately
 one-half of the patients returning for follow up at 9 months and approximately one-half
 returning for follow up at 12 months.

 At select centers, a subset of approximately 20 patients will undergo FFR pressure wire
 measurement at baseline and at follow-up (or at a minimum follow-up) in conjunction with the
 IVUS imaging, and will also undergo OCT imaging at 9 or 12 months.

 The primary safety endpoint is Target Lesion Failure at 6 months. TLF is a composite endpoint
 defined as cardiac death, target vessel MI, and clinically-indicated target lesion
 revascularization.

 The primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is the
 change in mean in-device area and mean lumen area at 9 or 12 months compared to
 post-procedure as measured by IVUS.

 Co-primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is late
 lumen loss as measured by QCA and IVUS at 9 or 12 months.
General Inclusion Criteria:

 1. Patient must be at least 18 years of age.

 2. Patient is able to verbally confirm understanding of risks, benefits and treatment
 alternatives of receiving the DynamX Novolimus Eluting Coronary Stent System (CSS) 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.

 3. 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)

 4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG)
 surgery

 5. Patient must agree to undergo all clinical study required follow-up visits,
 angiograms, and IVUS testing

 6. Patient must agree not to participate in any other clinical study for a period of one
 year following the index procedure.

 Angiographic Inclusion Criteria - Target Lesion/Vessel

 1. Target lesion must be located in a native coronary artery with a nominal vessel
 diameter of ≥ 2.5 and ≤3.5 mm assessed visually or by online QCA

 2. Target lesion must measure ≤ 24 mm in length

 3. Target lesion must be in a major artery or branch with a visually estimated stenosis
 of ≥ 50% and < 90% with a TIMI flow of ≥ 2

 4. The lesion must be successfully pre-dilated (less than 35% DS) prior to enrollment

 Angiographic Inclusion Criteria - non-Target Lesion/Vessel Treatment

 1. Treatment of a single, non-target lesion located in a separate major epicardial vessel
 (defined as LAD with septal and diagonal branches, LCX with obtuse marginal and/or ramus
 intermedius branches and RCA and any of its branches) attempted during the index procedure
 must be completed first using an approved 'olimus drug eluting stent. The segment must be
 located such that any injury that might occur during intervention can be clearly
 attributable to the treated non-target vessel. If the procedure is deemed uncomplicated and
 optimal, treatment of the target lesion with the DynamX stent can be considered.

 Optimal lesion/vessel treatment defined as:

 -  < 10% but no more than 15% residual diameter stenosis by visual assessment

 -  no evidence of dissection

 -  no evidence of thrombus in the treated lesion or vessel

 -  TIMI 3 flow

 -  Stent completely covers lesion and extends to healthy vessel on both sides (healthy to
 healthy)

 General Exclusion Criteria

 1. 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

 2. Patient is currently experiencing clinical symptoms consistent with AMI

 3. Patient requires the use of any rotablator intervention during the index procedure

 4. Patient has current unstable arrhythmias

 5. Patient presenting with heart failure, chronic arrhythmia, COPD or lung function
 impairment

 6. Patient has a known left ventricular ejection fraction (LVEF) < 30%

 7. Patient has received a heart transplant or any other organ transplant or is on a
 waiting list for any organ transplant

 8. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30
 days prior to or after the procedure

 9. Patient is receiving immunosuppression therapy and has known immunosuppressive or
 autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus
 etc.)

 10. Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that
 cannot be stopped and restarted according to local hospital standard procedures.

 11. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and
 bivalirudin, clopidogrel, prasugrel or ticagrelor, Novolimus, CoCr alloys, PLLA
 polymers or contrast sensitivity that cannot be adequately pre-medicated

 12. Elective surgery is planned within the first 6 months after the procedure that will
 require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors.

 13. 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.

 14. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5
 mg/dL, or patient on dialysis)

 15. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood
 transfusions

 16. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological
 attack (TIA) within the past six months

 17. Patient has had a significant GI or urinary bleed within the past six months

 18. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath
 insertion

 19. 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)

 20. Patient is already participating in another clinical study which has not reached the
 primary endpoint (long-term follow-up is not an exclusion)

 21. 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

 22. 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

 1. Target lesion(s) meets any of the following criteria:

 1. Aorto-ostial location

 2. Left main location

 3. Tapering within target segment of 0.5mm or greater

 4. Located within 10 mm of the origin of the LAD or LCX

 5. Located within an arterial or saphenous vein graft or distal to a diseased
 arterial or saphenous vein graft

 6. Lesion involving a side branch >2mm in diameter or bifurcation

 7. Previous placement of a stent proximal to or within 10 mm of the target lesion

 8. Total or sub-total occlusion (TIMI flow ≤ 1)

 9. Excessive tortuosity or angulation (≥ 45o) proximal to or within the lesion

 10. The proximal target vessel or target lesion is moderately or severely calcified
 by visual assessment, or lesion prevents full pre-dilatation balloon expansion

 11. Previous intervention restenosis

 2. The target vessel contains visible thrombus

 3. Another clinically significant lesion (>40%) is located in the same major epicardial
 vessel as the target lesion (including side branches)

 4. Patient has a high probability that a procedure other than pre-dilatation and stenting
 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)

 5. Target vessel was previously treated with any type of PCI < 6 months prior to index
 procedure

 6. Non-Target vessel was previously treated with any type of PCI < 30 days prior to the
 index procedure