Abbott Next Generation Drug Eluting Stent 48mm Study
Abbott Next Generation Drug Eluting Stent 48mm Study
The purpose of this SPIRIT 48 study is to evaluate the safety and effectiveness of the ABT NG
 DES 48 in improving coronary artery luminal diameter in subjects with coronary artery disease
 (CAD) due to de novo native coronary artery long lesions.
The SPIRIT 48 mm study is a prospective, single arm, open-label, multi-center global (US and
 outside of US) clinical investigation to evaluate the safety and effectiveness of the ABT
 Next Generation Drug Eluting Stent 48 mm everolimus-eluting coronary stent system (EECSS)
 (called "ABT NG DES 48") in up to 107 subjects at up to 33 sites globally. The clinical
 outcomes from the SPIRIT 48 study will be compared to a performance goal (PG) established
 using historical control data from the SPIRIT Prime Long Lesion Registry. This clinical
 investigation will be conducted under an investigational device exemption (IDE) and is
 intended to support market approval of the ABT NG DES 48 in the United States.
General Inclusion Criteria:

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

 2. Subject or a legally authorized representative must provide written informed consent
 prior to any study related procedure, per site requirements.

 3. Subject must have evidence of myocardial ischemia (e.g., unstable angina, post-infarct
 angina, stable angina or silent ischemia) suitable for non-emergent PCI. Subject with
 stable angina or silent ischemia must have objective sign of ischemia as suggested by
 one of the following,

 -  Abnormal stress or imaging stress test,

 -  Abnormal computed tomography-fractional flow reserve (CT-FFR)

 -  Stenosis by visual estimation ≥ 70%

 -  Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio [iFR], or
 relative flow reserve [RFR])

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

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

 Angiographic Inclusion Criteria:

 1. Only one de novo target lesion in native coronary artery is allowed to be treated with
 the investigational stent.

 • One additional non-target lesion can be treated if it is located in a different
 epicardial coronary vessel and NOT in left main coronary artery. The non-target lesion
 must be treated first and must be deemed an angiographic success.

 2. The target lesion must be located in a native coronary artery with:

 -  Visually estimated reference vessel diameter (RVD) of ≥ 2.5 mm and ≤ 4.25 mm.

 -  Visually estimated lesion length of > 32 mm and ≤ 44 mm, and must be covered by a
 single ABT NG DES 48.

 a. Multiple focal de novo lesions in an epicardial coronary vessel are allowed if
 the lesions can be covered by one stent. Multiple focal de novo lesions will be
 counted as a single lesion.

 -  Visually estimated diameter stenosis of > 50% and < 100% with a Thrombolysis in
 Myocardial Infarction (TIMI) flow of ≥ 1 .

 -  Stable angina or silent ischemia subjects must have stenosis ≥ 70%, or abnormal
 pressure-derived physiological indices (FFR, iFR, or RFR), unless abnormal stress
 or imaging stress test is evidenced.

 General Exclusion Criteria:

 1. Subject has known hypersensitivity or contraindication to device material and its
 degradants (everolimus, cobalt, chromium, nickel, tungsten, acrylic and
 fluoropolymers, etc.), or has known contrast sensitivity.

 2. Subject has known hypersensitivity or contraindication to aspirin,
 heparin/bivalirudin, P2Y12 inhibitors (clopidogrel /prasugrel /ticagrelor), and
 therefore cannot be adequately pre-medicated.

 3. Subject has a planned surgery or procedure necessitating discontinuation of aspirin or
 P2Y12 inhibitor within 12 months following index procedure.

 4. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin,
 dabigatran, apixaban, rivaroxaban or any other agent for any reason).

 5. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year
 following index procedure. Female subjects of child-bearing potential must have a
 negative pregnancy test done within 7 days prior to the index procedure per site
 standard test.

 6. Subject had an acute myocardial infarction (AMI) within 48 hours of the index
 procedure with either of the situations below:

 -  The subject is currently experiencing clinical symptoms consistent with new onset
 AMI, such as nitrate-unresponsive prolonged chest pain with ischemic
 electrocardiogram (ECG) changes

 -  Elevated cardiac biomarker values have not returned to within normal limits at
 the time of index procedure.

 7. Subject has a left ventricular ejection fraction (LVEF) < 30% within 3 months prior to
 the index procedure, that was documented by any method.

 8. Subject is expected to require percutaneous mechanical cardiac support at the index
 procedure.

 9. Prior PCI within the target vessel during the last 12 months prior to consent.

 10. Prior PCI within the non-target vessel or any peripheral intervention during the last
 30 days prior to consent.

 11. At the index procedure, subject is identified to require planned stenting procedure
 (including staged procedures) or CABG after the index procedure.

 12. Subject has received a solid organ transplant which is functioning or is active on a
 waiting list for any solid organ transplants with expected transplantation within 24
 months.

 13. Subject has a malignancy that is not in remission.

 14. Subject is receiving immunosuppressant therapy or has known life-threatening
 immunosuppressive or severe autoimmune disease (e.g., human immunodeficiency virus,
 systemic lupus erythematosus, etc.). Note: corticosteroids are not included as
 immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease

 15. Subject has previously received or is scheduled to receive radiotherapy to a coronary
 artery (vascular brachytherapy), or the chest/mediastinum.

 16. Subject has a platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3.

 17. Subject has renal insufficiency as defined as an estimated glomerular filtration rate
 (GFR) < 30 ml/min/1.73m^2 or dialysis at the time of consent.

 18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis
 or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed
 within the past six months.

 19. Subject has had a cerebrovascular accident or transient ischemic neurological attack
 (TIA) within the past 6 months, or any prior intracranial bleed, or any permanent
 neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous
 malformation, etc.).

 20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath
 insertion. Note: femoral arterial disease does not exclude the subject if radial
 access may be used.

 21. Subject has life expectancy < 2 years.

 22. Subject is, in the opinion of the Investigator or designee, unable to comply with the
 requirements of the study protocol or is unsuitable for the study for any reason. This
 includes completion of Subject Reported Outcome instruments.

 23. Subject is currently participating in another clinical investigation (except for
 non-invasive observational studies) that has not yet completed its primary endpoint.

 24. Subject intends to participate in another investigational drug or device clinical
 investigation (except for non-invasive observational studies) within 12 months after
 the index procedure.

 25. Subject 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 protocol, confound the data interpretation or is associated
 with a limited life expectancy less than 2 years.

 26. Presence of other anatomic or comorbid conditions, or other medical, social, or
 psychological conditions that, in the investigator's opinion, could limit the
 subject's ability to participate in the clinical investigation or to comply with
 follow-up requirements, or impact the scientific soundness of the clinical
 investigation results.

 27. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly
 spreading novel infectious agent within the prior 2 months.

 Angiographic Exclusion Criteria:

 1. Target lesion/vessel meets any of the following criteria;

 -  Prevents complete angioplasty balloon (plain old balloon angioplasty [POBA],
 scoring balloon, or cutting balloon) inflation, such as:

 -  Heavy calcified lesion

 -  Requires additional device for lesion preparation (e.g. rotablator or
 laser).

 -  Anatomy proximal to or within the lesion that prevents proper placement of
 delivery system.

 -  Extreme angulation (≥ 90°) proximal to or within the target lesion.

 -  Excessive tortuosity (≥ two 45° angles) proximal to or within the target
 lesion.

 -  Involves a bifurcation of which the side branch will be jailed by the struts and
 requiring side branch pre-dilatation (including Kissing Balloon Technique),
 and/or stenting

 -  Is located:

 -  In left main or there is a ≥30% diameter stenosis in the left main (unless
 the left main lesion is a protected left main (i.e. a patent bypass graft to
 the left anterior descending coronary artery [LAD] and/or left circumflex
 coronary artery [LCX] arteries is present), and there is no intention to
 treat the protected left main lesion.

 -  Within 3 mm of the origin of the LAD or LCX.

 -  Within 3 mm of aorto-ostial right coronary artery (RCA).

 -  In a bypass graft or distal to anastomotic site of bypass graft.

 -  With total occlusion (TIMI flow 0), prior to crossing with the wire.

 -  Contains thrombus

 -  The subject has been previously treated with a stent at any time prior to the
 index procedure such that the ABT NG DES 48 would need to cross the stent to
 reach the target lesion.

 2. Unsuccessful target lesion pre-dilatation, defined as the presence of one or more of
 the following:

 -  Residual % diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visual
 estimation).

 -  TIMI flow grade <3 (per visual estimation).

 -  Any angiographic complication (e.g. distal embolization, no-reflow)

 -  Any dissection National Heart, Lung, and Blood Institute (NHLBI) grade D-F.

 -  Any chest pain lasting > 5 minutes.

 -  Any ST-segment depression or elevation lasting > 5 minutes.

 -  Side branch requires additional dilatation/stenting caused by plaque shift,
 carina shift or may require additional dilatation/stenting after stent
 implantation, per the operator's assessment.

 3. Non-target lesion meets any of the following criteria:

 -  Is located in the target vessel

 -  Is located in the left main location

 -  Is restenotic from a previous stent implantation

 -  Is located within a saphenous vein graft or an arterial graft

 -  Is with a TIMI flow 0 (total occlusion) prior to guide wire crossing

 -  Involves a complex bifurcation that needs two-stent strategy.

 4. Treatment of non-target lesion is not deemed successful.

 Note: A successful treatment is defined as a treatment resulted in a mean lesion diameter
 stenosis < 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by
 the physician, without the occurrence of prolonged chest pain or ECG changes consistent
 with MI.