DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions

This prospective study will evaluate the safety and effectiveness of two FDA 510(k) cleared
DA products (Medtronic HawkOne® and TurboHawkM)19-21 and FDA approved drug-coated balloon
(Medtronic IN.PACT® Admiral®)22 used in combination to debulk moderate and severely calcified
femoropopliteal artery atherosclerotic lesions as defined by the published Peripheral
Arterial Calcium Scoring System (PACSS) followed by treatment with the Medtronic IN.PACT®
Admiral® DCB for the prevention of restenosis as assessed at 12-month follow-up. The data
will be independently adjudicated by an angiographic and DUS core labs. An independent IVUS
core lab to determine change in maximal luminal plaque area, pre- and post-atherectomy and
post-adjunctive DCB therapy will adjudicate the assessment of debulking effectiveness. The
operator will be blinded to all IVUS images and procedural success will be based on usual and
customary angiographic visual assessments. The post-atherectomy plaque debulking
effectiveness (change in plaque area) and vascular calcium severity as assessed by IVUS will
be correlated with the angiographic metrics of RVD, pre- and post-treatment MLD, calcium
grade (using PACSS), lesion length, sub-intimal wire passage, CTO length, and angiographic
patterns of restenosis in all patients who sustain a CD-TLR through 12-months. All
atherectomy specimens will be collected and provided to an independent histology laboratory
for analysis of calcium content and vessel wall elements. The amount of embolic debris
captured in the Spider® Distal Protection Device will be visually assessed. The study will
validate PACSS definitions of moderate and severe calcium and its location (intimal, medial
or mixed) as they relate to intra-procedural and Major Adverse Events (MAEs) through 30-day
clinical follow-up (e.g., grade D-F dissections requiring provisional stenting, vessel
perforation requiring an additional intervention or surgery, vessel thrombosis requiring
adjunctive technologies and/or lytic agents, unplanned amputation, intra-procedure distal
embolization, and CD-TLR).

Inclusion Criteria:

General Inclusion Criteria:

1. Willing and able to provide informed consent;

2. Age ≥ 18 years of age;

3. Clinical evaluation determines Rutherford Category 2-4;

4. Willing to comply with all study requirements;

5. All lab work is within acceptable limits to undergo a percutaneous interventional
procedure.

6. Life expectancy, in the investigator's opinion, of at least 24 months.

Angiographic Inclusion Criteria:

1. RVD ≥ 4mm and ≤ 7mm;

2. Evidence of a ≥70% de novo or restenotic lesion or occlusion in the target lesion
defined as in the superficial femoral artery and/or popliteal artery, located in the
arterial segment starting at least 1 cm beyond the Common Femoral Artery (CFA)
bifurcation between the superficial and profunda femoris arteries (proximal anatomical
landmark) to the distal P2 segment of the popliteal artery;

3. Total lesion/occlusion length:

a. ≥ 8 cm and ≤ 18 cm

4. Total occlusion length

a. ≥ 6 cm and ≤10 cm

5. Stenosis or occlusion begins 1cm below the profunda-SFA bifurcation;

6. Femoral or popliteal stenosis or occlusion that does not extend beyond the P2
popliteal segment;

7. Minimum 1 patent infrapopliteal vessel to the foot with ≤ 50% diameter stenosis;

8. Grade 3 or 4 intimal, medial and/or mixed calcification per the PACSS as judged by the
operator at the time of the procedure;

9. Index lesion fits within guidelines below:

9.1 If two lesions are ≤ 3 cm apart, treatment would be allowed as a single lesion
providing they contain a segment of moderate or severe calcification and the total
lesion length is ≥ 8 cm and ≤18 cm.

9.2 If more than one lesion is within the target vessel, and they are separated by > 3
cm of normal vessel, one lesion must be designated by the investigator as the target
lesion as long as the lesion meets all angiographic eligibility criteria. Only one
index lesion is permitted for analysis, but study will allow a second lesion to be
treated as a non-target lesion.

10. Infrapopliteal lesion, if diagnosed, can be staged and treated > 30 days after index
procedure.

Exclusion Criteria:

General Exclusion Criteria:

1. Renal failure or chronic kidney disease with GFR ≤30 ml/min or MDRD GFR ≤30 ml/min per
1.73m2 (and serum creatinine ≥2.5 mg/dL within 30 days of index procedure);

2. Physician does not believe subject is an appropriate candidate for study;

3. Previous infra-inguinal intervention in the index limb within 30 days of the planned
femoropopliteal intervention

Angiographic Exclusion Criteria:

1. Inability to cross lesion/occlusion with a guidewire or re-entry device;

2. Inability for the guidewire to re-enter and/or remain in the true lumen prior to
enrollment;

3. In-stent restenosis of the target lesion, or recognition of any stent (patent or
re-stenotic within the femoropopliteal segment of the index limb;

4. Aneurysm located in the target vessel or aneurysmal vessel;

5. Acute thrombus in the index limb prior to enrollment.