ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System for the Treatment of Subjects With Symptomatic Claudication From Occlusive Vascular Disease of the Superficial Femoral (SFA) or Common or External Iliac Arteries.

The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.

Inclusion Criteria:

1. Subject is ≥ 18 and ≤ 80 years of age at the time of signing informed consent.

2. Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 1-3).

   For subjects with bilateral lesions, the higher Rutherford-Becker Clinical Category limb will be considered the target extremity to be treated in this trial.

   If both limbs are of the same Rutherford Becker Clinical Category, the target extremity will be selected based on investigator discretion.

3. Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.

4. Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.

5. Female subject of childbearing potential must: have had a negative pregnancy test within 14 days before treatment; not be nursing at the time of the study procedure and agree at time of consent to use birth control during participation in this trial.

6. Subject has life expectancy > 12 months.

7. Subject is able to take clopidogrel or prasugrel (or ticlopidine, if the subject cannot take clopidogrel or prasugrel) and acetylsalicylic acid (aspirin).

8. Subject must agree not to participate in any other clinical investigation for a period of 12 months following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.

Angiographic Inclusion Criteria

1. A single de novo native disease segment of the superficial femoral (SFA) or common or external iliac arteries of the target extremity located within the following anatomical parameters:

   Iliac

   • Proximal margin of target lesion is ≥ 2.5 cm distal to the aortic bifurcation in common iliac artery
   • Distal margin of target lesion is ≥ 1.5 cm proximal to the location of inguinal ligament

   SFA

   • Proximal margin of target lesion is ≥ 1 cm distal to the common femoral artery bifurcation
   • Distal margin of target lesion is ≤ 25 cm distal to the common femoral artery bifurcation

2. Vessel diameter from ≥ 5.5 mm to ≤ 6.5 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines

3. Target lesion is ≥ 50% DS

4. Target lesion length ≤ 50 mm

5. Patent inflow artery free from significant lesion (≥ 50% DS and < 100% DS) as confirmed by angiography (treatment of the target lesion acceptable after successful treatment of inflow artery lesion)

6. Patent popliteal artery free from significant lesion (≥ 50% DS) with at least one patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) that provides in-line circulation to the lower leg and foot, as confirmed by angiography

Exclusion Criteria:

1. A platelet count <100,000 cells/mm3 or >700,000 cells/mm3; a white blood cell count (WBC) <3,000 cells/mm3; or hemoglobin < 10.0 g/dL
2. Acute or chronic renal dysfunction (creatinine > 2.5 mg/dl or >176μmol/L)
3. Severe liver impairment as defined by total bilirubin ≥ 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT).
4. Known allergies to the following: aspirin, clopidogrel, prasugrel or ticlopidine, heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to everolimus (i.e. tacrolimus, sirolimus, zotarolimus) or other macrolides.
5. Subject requires planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel or ticlopidine.
6. Subject has had or will require treatment with drug eluting stent (DES) or drug coated balloon (DCB) within 6 months pre- or post-index procedure.
7. Subject is unable to walk.
8. Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.
9. Subject has received, or is on the waiting list for, a organ transplant.
10. Subject is on chronic hemodialysis.
11. Subject has uncontrolled diabetes mellitus (DM) (HbA1c ≥ 7.0%).
12. Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.
13. Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the subject's ability to walk.
14. Subject has unstable angina defined as rest angina with ECG changes.
15. Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.
16. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
17. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation or is associated with limited life-expectancy, i.e., less than 12 months.
18. Subject is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.)
19. Subject is unable to understand or unwilling to cooperate with study procedures.
20. Subject requires general anesthesia for the procedure.
21. Subject has ischemic or neuropathic ulcers on either foot.
22. Subject has prior minor or major amputation of either lower extremity.
23. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria

1. Contralateral lesion distal to the location of inguinal ligament that requires treatment within 30 days before or after the procedure. (Contralateral iliac artery lesions may be treated during the procedure if necessary for contralateral approach to the target lesion).

2. Target extremity has an angiographically significant (> 50% DS) lesion located distal to the target lesion.

3. Acute ischemia of the target extremity

4. Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.

5. Target vessel has been previously treated with any of the following: stent, laser, atherectomy, surgical bypass, or endarterectomy.

6. Total occlusion (100% DS) of the ipsilateral inflow artery.

7. Angiographic evidence of thrombus in target vessel.

8. The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) (e.g. but not limited to, directional atherectomy, excimer laser, rotational atherectomy, brachytherapy, cryoplasty, etc.)

9. Target lesion is within or adjacent to an aneurysm.

10. Subject has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion.

11. Target lesion has moderate-to-severe calcification with either of the following characteristics:

    • Circumferential orientation
    • Thickness > 2 mm in either radial or longitudinal direction

12. Subject has an abdominal aortic aneurysm > 3 cm or history of aortic revascularization.