ABSORB PHYSIOLOGY Clinical Investigation
ABSORB PHYSIOLOGY Clinical Investigation
The target enrollment goal for the trial was to enroll 36 subjects. However due to a
 challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the
 trial was initiated in June 2011.

 To evaluate the following in participants undergoing coronary artery scaffolding/stenting for
 significant coronary artery disease:

 -  The acute (post-implantation) effect of an implanted bioresorbable vascular scaffold
 (BVS) or metallic drug eluting stent (mDES) on coronary blood flow and physiological
 responsiveness of the target coronary artery

 -  The long-term (2 years) effect of an implanted BVS or mDES on coronary blood flow and
 physiological responsiveness of the target coronary artery
-  Prospective, randomized, single-blinded, multi-center clinical investigation comparing
 target vessel and non-intervened, self-control vessel within participants and between
 participants undergoing BVS or mDES deployment for the treatment of a single de novo
 native coronary artery lesion

 -  The investigation will include two arms:

 -  Study device (BVS) arm: Abbott Vascular's Everolimus-Eluting Bioresorbable Vascular
 Scaffold

 -  Control device (mDES) arm: Abbott Vascular's Everolimus-Eluting XIENCE V or XIENCE
 PRIME
Inclusion Criteria:

 1. Participant must be a male of at least 18 years of age or a female that is
 post-menopausal and not on hormone replacement therapy.

 2. Participant is able to verbally confirm understanding of risks, benefits and treatment
 alternatives and he/she or his/her legally authorized representative must provide
 written informed consent prior to any clinical investigation related procedure, as
 approved by the appropriate Ethics Committee of the respective clinical site.

 3. Participant must have evidence of myocardial ischemia (e.g., stable or unstable
 angina, silent ischemia with a positive functional study).

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

 5. Participant must agree to undergo all clinical investigation plan-required follow-up
 visits.

 6. Participant must agree not to participate in any other clinical investigation for a
 period of 2 years following the index procedure. This includes clinical trials of
 medications and invasive procedures. Only questionnaire-based studies are allowed.

 Angiographic Inclusion Criteria:

 1. A single de novo native coronary artery lesion suitable to be treated by either a BVS
 or a mDES.

 2. Target lesion must be located in a native coronary artery in which the mean proximal
 and distal vessel diameter of the target lesion (Dmean) fall within the range of ≥
 2.25 mm and ≤ 3.25 mm and the target lesion length measures ≤ 22 mm as assessed by
 IVUS.

 3. Target lesion must be located in the main branch of a major epicardial vessel (i.e.,
 LAD, LCX, or RCA) with a visually estimated diameter stenosis of ≥ 50% and < 100% with
 a TIMI flow of ≥ 1.

 4. Participant must have an additional angiographically smooth (< 40% diameter stenosis)
 non-target vessel to act as an intra-participant control vessel (self-control vessel).
 The self-control vessel must be the main branch of a major epicardial vessel (i.e.,
 LAD, LCX, or RCA).

 5. Coronary anatomy must be suitable for IVUS, OCT, and pressure and flow wire
 instrumentation.

 General Exclusion Criteria:

 1. Participant has a known diagnosis of spontaneous acute myocardial infarction (AMI)
 within 14 days preceding the index procedure.

 2. Participant has high-risk acute coronary syndrome (e.g., dynamic ST-T wave change on
 ECG or recurrent chest pain/nitrate-unresponsive prolonged chest pain at rest within
 48 hours prior to the index procedure).

 3. Participant has any evidence of myocardial infarct in the territory subtended by the
 proposed target vessel or self-control vessel.

 4. Participant has current unstable arrhythmias.

 5. Participant has chronic atrial fibrillation.

 6. Participant has a known left ventricular ejection fraction (LVEF) < 40%.

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

 8. Participant has previously had CABG or mitral or aortic valve repair/replacement.

 9. Participant is receiving or scheduled to receive chemotherapy for malignancy within 30
 days prior to or after the index procedure.

 10. Participant is receiving immunosuppressant therapy or has known immunosuppressive or
 autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus,
 etc.).

 11. Participant has a chronic systemic condition or medication likely to interfere with
 coronary physiology and/or conduit artery function (e.g., chronic inflammatory
 condition, chronic renal failure, or chronic obstructive pulmonary disease).

 12. Participant has known renal insufficiency.

 13. Participant is receiving or scheduled to receive any planned radiotherapy.

 14. Participant is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) at
 the onset of the clinical investigation.

 15. Participant has a known hypersensitivity or contraindication to aspirin,
 heparin/bivalirudin, anti-platelet medications specified for use in the study
 (clopidogrel, prasugrel and ticlopidine, inclusive), everolimus, poly (L-lactide),
 poly (DL-lactide), cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro
 polymers, or contrast sensitivity that cannot be adequately pre-medicated.

 16. Elective surgery is planned within the first 6 months after the index procedure that
 will require discontinuing aspirin, clopidogrel, prasugrel, or ticlopidine.

 17. Participant 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 (including laboratory
 evidence of hepatitis) within 7 days prior to the index procedure.

 18. Participant has a history of bleeding diathesis or coagulopathy or will refuse blood
 transfusions.

 19. Participant has had a cerebrovascular accident/stroke (CVA) or transient ischemic
 neurological attack (TIA) within the past 6 months.

 20. Participant has had a significant gastro-intestinal or significant urinary bleed
 within the past 6 months.

 21. Participant has extensive peripheral vascular disease that precludes safe 6 French
 sheath insertion.

 22. Participant has a history of paradoxical exercise-induced vasoconstriction that is
 consistent with myocardial bridging in the coronary anatomy.

 23. Participant has other medical illness (e.g., cancer or congestive heart failure) or
 known history of substance abuse (alcohol, cocaine, heroin etc.) that in the judgment
 of the Investigator may cause non-compliance with the clinical investigation plan,
 confound the data interpretation or is associated with a limited life expectancy.

 24. Participant is currently participating in another clinical investigation that has not
 yet reached its primary endpoint.

 25. Percutaneous interventions for lesions in the third major epicardial vessel (the one
 that does not contain the target or the self-control vessel) were performed within 30
 days preceding the index procedure or are planned to be done within 6 months following
 the index procedure.

 26. Planned PCI procedures in the target vessel (and/or any of its side branches) or the
 self-control vessel (and/or any of its side branches) within 2 years following the
 index procedure.

 27. Participant who does not suspend drugs that will influence vaso-function.

 Angiographic Exclusion Criteria

 1. Target lesion meets any of the following criteria:

 1. Left main location;

 2. RCA aorto-ostial location (within 10 mm from expected proximal stent/scaffold
 edge);

 3. LAD or LCX ostial location (within 10 mm from expected proximal stent/scaffold
 edge);

 4. Involves a bifurcation with a side branch ≥ 2 mm in diameter, an ostial lesion >
 40% stenosed by visual estimation, or a side branch requiring pre-dilatation;

 5. Total occlusion (TIMI flow 0) prior to wire crossing;

 6. Excessive tortuosity proximal to or within the lesion;

 7. Extreme angulation (≥ 90°) proximal to or within the lesion;

 8. Heavy calcification in the lesion;

 9. Located in a side branch.

 2. Participant has a high probability that a procedure other than pre-dilatation,
 scaffold/stent implantation, and post-dilatation (if applicable) will be required at
 the time of index procedure for treatment of the target vessel (e.g., atherectomy,
 cutting balloon or brachytherapy).

 3. The target vessel (and/or any of its side branches) or the self-control vessel (and/or
 any of its side branches) contains visible thrombus.

 4. The target vessel or the self-control vessel has previously been treated by any PCI
 procedures.

 5. A side branch of the target vessel or a side branch of the self-control vessel has
 received any percutaneous interventions within 30 days prior to the index procedure.

 6. Another clinically significant lesion is located in the target vessel (and/or any of
 its side branches) or the self-control vessel (and/or any of its side branches) that
 may require PCI treatments within 2 years following the index procedure.

 7. Participant has evidence of myocardial bridging in the coronary anatomy during the
 angiographic evaluation.