Abbott Next Generation Drug Eluting Stent 48mm Study (ABT NG DES 48)

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 able to 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

     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.

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

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

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

4. Prior PCI within the non-target vessel or any peripheral intervention during the last

30 days prior to consent.

1. At the index procedure, subject is identified to require planned stenting procedure

(including staged procedures) or CABG after the index procedure.

1. 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.

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

2. 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

1. Subject has previously received or is scheduled to receive radiotherapy to a coronary

artery (vascular brachytherapy), or the chest/mediastinum.

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

2. 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.

1. 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.

1. 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.).

1. 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.

1. Subject has life expectancy < 2 years.

2. 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.

1. Subject is currently participating in another clinical investigation (except for

non-invasive observational studies) that has not yet completed its primary endpoint.

1. 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.

1. 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.

1. 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.

1. 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 by 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 within 1-year prior to the index procedure such that the ABT NG DES 48 would need to cross the stent to reach the target lesion.

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

The following:

• Failed for a full inflation of the pre-dilatation balloon.

• TIMI flow grade 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.

1. 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.

2. 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.