Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Screening Criteria

Male or non-pregnant female ≥18 years of age
Rutherford Clinical Category 2-4
Clinical diagnosis of PAD requiring revascularization, secondary to atherosclerosis affecting a lower limb
Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen

Procedural Criteria

De novo or nonstented restenotic lesions >90 days from prior angioplasty and/or atherectomy, at least 3 cm from any previously placed stent or vascular surgery site
>70% diameter stenosis up to 15 cm in total length (with no greater than 3 cm length of contiguous intervening normal artery) in the superficial femoral and/or popliteal artery (between the profunda and tibioperoneal trunk)
Reference vessel diameter ≥3mm and ≤ 8mm
Successful wire crossing of lesion
A patent artery proximal to the index lesion free from significant stenosis (significant stenosis is defined as >50% in iliac or >30% stenosis in common femoral artery) as confirmed by angiography (treatment of target lesion after successful treatment of iliac or common femoral artery lesions is acceptable)

Exclusion Criteria:

Screening Criteria

Pregnant, nursing or planning on becoming pregnant in < 2 years
Life expectancy of <2 years
Known active malignancy
History of solid organ transplantation
Patient actively participating in another investigational device or drug study
History of hemorrhagic stroke within 3 months
Previous or planned surgical or interventional procedure within 30 days of index procedure
Chronic renal insufficiency with eGFR <29
Prior bypass surgery, stenting of the target lesion
Inability to take required study medications
Contra-indication or known hypersensitivity to dexamethasone sodium phosphate, contrast media, or Physician prescribed antiplatelet regimen as indicated
Systemic fungal infection
Anticipated use of IIb/IIIa inhibitor prior to index lesion treatment
Acute or sub-acute thrombus, acute vessel occlusion or sudden symptom onset
Acute limb ischemia
Prior participation of the index limb in the current study (contralateral treatment is allowed)
Inability to ambulate (e.g. from prior ipsilateral or contralateral amputation)
Patient is receiving steroids already, however locally acting inhaled steroids for asthma treatment do not exclude patients from the trial

Procedural Criteria

Lesions extending into the trifurcation or above the profunda
Heavy eccentric or moderate circumferential calcification at index lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Catheter needle through the vessel wall
Lesion length is >15 cm as measured from proximal normal vessel to distal normal vessel, or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
Inadequate distal outflow defined as absence of at least one patent tibial artery (no lesion >50% stenosis) with flow into the foot
Use of adjunctive therapies other than angioplasty, atherectomy (mechanical or laser) or bare metal stenting (i.e. scoring/cutting balloon, drug-eluting stent, drug-coated balloon, cryoplasty, etc.)