The Chocolate Touch Study

The primary objective of the Chocolate Touch study is to demonstrate non-inferior safety and
non-inferior effectiveness of the Chocolate Touch™ compared to the Lutonix® drug coated
balloon catheter. These data are intended to show safety and effectiveness of the Chocolate
Touch sufficient to support regulatory approval to market this device in the United States
for use in superficial femoral or popliteal arteries.

Study success is defined as statistical demonstration of the non-inferiority hypothesis tests
for both the primary safety and effectiveness hypothesis.

Inclusion Criteria:

1. Minimum of 18 years of age

2. Intermittent claudication or ischemic rest pain (Rutherford 2-4)

3. Life Expectancy >2 years

4. Patient has agreed to follow-up requirements and given informed consent

5. Lesion successfully crossed with a guidewire

6. Lesion in the superficial femoral or popliteal artery

7. Target lesion >70% stenosis

8. Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate
Touch to be used 1.1:1 at Target Lesion

9. Target Lesion <18cm that consists of no more than two adjacent lesions (<25mm apart)
and is able to be completely covered with inflation of no more than two assigned
balloons

10. Angiographic evidence of distal run-off demonstrated by at least one patent tibial
vessel without evidence of significant (>70%) stenosis from origin to to ankle

11. In-flow vessel without significant stenosis (<70%) or successful treatment (<30%
residual stenosis with no complications) of a diseased iliac vessel

Exclusion Criteria:

1. Acute limb ischemia, or patient indicated for thrombolytic therapy

2. Planned surgery within 30 days including interventions on the non-target limb

3. Target Limb concurrent interventions involving a re-entry device, atherectomy, laser,
or ablation procedures, the use of a drug eluting stent, or, treatment with any other
drug coated balloon

4. Myocardial infarction or stroke within 30 days prior to the procedure

5. Known intolerance to required medications, contrast media, nitinol, or Paclitaxel

6. Known impaired Renal Function that could have an impact on contrast tolerance with
Glomerular filtration rate (GFR) ≤ 30 ml/min per 1.73 m^2 and/or elevated serum
creatinine >2.5mg/dL (220µmol/L)

7. Known bleeding disorder or uncontrolled hypercoagulable disorder

8. Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)

9. Female who is pregnant or intends to be pregnant during study

10. Patient is enrolled in another clinical study or was previously enrolled in this study

11. Presence of perforation, dissection or other injury at access site or in target vessel
at time of enrollment

12. Severe Calcification at the target lesion (defined as angiographic evidence of dense
calcification present on both sides of the vessel wall on two orthogonal views and
that extends >5 continuous cm in length)

13. Previous bypass graft or stent at target vessel, OR, iliac stent that cannot permit
crossing by the treatment balloon within the introducer sheath