Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled,
noninferiority clinical trial. The trial will randomize approximately 446 subjects with
symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting
eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the
IN.PACT Admiral DCB, and followed for 60 months.

Inclusion Criteria:

- Subject is ≥18 years.

- Subject has target limb Rutherford classification 2, 3 or 4.

- Subject has provided written informed consent and is willing to comply with study
follow-up requirements.

- De novo lesion(s) or non-stented restenotic lesion(s) occurring >90 days after prior
plain old balloon (POBA) angioplasty or >180 days after prior DCB treatment.

- Target lesion location starts ≥10 mm below the common femoral bifurcation and
terminates distally at or above the end of the P1 segment of the popliteal artery.

- Target vessel diameter ≥4 mm and ≤7 mm.

- Target lesion must have angiographic evidence of ≥70% stenosis by operator visual
estimate.

- Chronic total occlusions may be included only after successful, uncomplicated wire
crossing of target lesion via an anterograde approach and without the use of
subintimal dissection techniques.

- Target lesion must be ≤180 mm in length (one long lesion or multiple serial lesions)
by operator visual estimate. Note: combination lesions must have a total lesion length
of ≤180 mm by visual estimate and be separated by ≤30 mm.

- Target lesion is located at least 30 mm from any stent, if target vessel was
previously stented.

- Successful, uncomplicated (without use of a crossing device) wire crossing of target
lesion. Successful crossing of the target lesion occurs when the tip of the guide wire
is distal to the target lesion without the occurrence of flow-limiting dissection or
perforation and is judged by visual inspection to be within the true lumen.

- After pre-dilatation, the target lesion is ≤70% residual stenosis, absence of a flow
limiting dissection and treatable with available device matrix.

- A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by
angiography.

- At least one patent native outflow artery to the ankle or foot, free from significant
stenosis (≥50% stenosis) as confirmed by angiography.

Exclusion Criteria:

- Subject has acute limb ischemia.

- Subject underwent percutaneous transluminal angioplasty (PTA) of the target limb using
plain old balloon angioplasty (POBA) or a stent within the previous 90 days.

- Subject underwent any lower extremity percutaneous treatment using a
paclitaxel-eluting stent or a DCB within the previous 90 days.

- Subject underwent PTA of the target lesion using a DCB within the previous 180 days.

- Subject has had prior vascular intervention in the contralateral limb within 14 days
before the planned study index procedure or subject has planned vascular intervention
in the contralateral limb within 30 days after the index procedure.

- Subject is pregnant, breast-feeding or intends to become pregnant during the time of
the study.

- Subject has life expectancy less than 2 years.

- Subject has a known allergy to contrast medium that cannot be adequately
pre-medicated.

- Subject is allergic to ALL antiplatelet treatments.

- Subject has impaired renal function (i.e. serum creatinine level ≥2.5 mg/dL).

- Subject is dialysis dependent.

- Subject is receiving immunosuppressant therapy.

- Subject has known or suspected active infection at the time of the index procedure.

- Subject has platelet count <100,000/mm3 or >700,000/mm3.

- Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3
months prior to the study procedure.

- Subject is diagnosed with coagulopathy that precludes treatment with systemic
anticoagulation and/or dual antiplatelet therapy (DAPT).

- Subject has history of stroke within the past 90 days.

- Subject has a history of myocardial infarction within the past 30 days.

- Subject is unable to tolerate blood transfusions because of religious beliefs or other
reasons.

- Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol.

- Subject is participating in another investigational drug or medical device study that
has not completed primary endpoint(s) evaluation or that clinically interferes with
the endpoints from this study, or subject is planning to participate in such studies
prior to the completion of this study.

- Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or
intervention unrelated to this study within 30 days prior to the index procedure or
has planned major surgical procedure or intervention within 30 days of the index
procedure.

- Subject had previous bypass surgery of the target lesion.

- Subject had previous treatment of the target vessel with thrombolysis or surgery.

- Subject is unwilling or unable to comply with procedures specified in the protocol or
has difficulty or inability to return for follow-up visits as specified by the
protocol.

- Target lesion has moderate to severe calcification or was previously treated with a
DCB for moderate to severe calcification (as defined by the PARC classification of
calcification).

- Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm).

- Target lesion requires treatment with alternative therapy such as stenting, laser,
atherectomy, cryoplasty, brachytherapy, re-entry devices, or subintimal dissection
techniques.

- Significant target vessel tortuosity or other parameters prohibiting access to the
target lesion.

- Presence of thrombus in the target vessel.

- Iliac inflow disease requiring treatment, unless the iliac artery disease is
successfully treated first during the index procedure. Success is defined as ≤30%
residual diameter stenosis without death or major complications.

- Presence of an aortic, iliac or femoral artificial graft.