Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging

Exclusion Criteria

• •Screening Criteria:
• •1. Any contraindication to receiving an MRI
• •2. Pregnant, nursing, or planning on becoming pregnant in \< 2yrs
• •3. Life expectancy of \< 1 yr
• •4. History of solid organ transplantation
• •5. Patient actively participating in another investigational device or drug study
• •6. History of hemorrhagic stroke within 3 months of index procedure
• •7. Previous or planned surgical or interventional procedure within 30 days of index procedure
• •8. Chronic renal insufficiency with eGFR \< 30
• •9. Prior bypass surgery, stenting, atherectomy or angioplasty of the index lesion
• •10. Inability to take required study medications
• •11. Contra-indication or known hypersensitivity to dexamethasone sodium phosphate, contrast media, gadolinium, aspirin or Plavix
• •12. Systemic fungal infection
• •13. Acute limb ischemia
• •14. Prior participation of the index limb in the current study (contralateral treatment is allowed)
• •15. Patient is being treated with long-term steroids (not including treatment of a bronchial condition with inhaled steroids)
• •Procedural Criteria:
• •1. Index lesions extending into the tibial trifurcation or above the profunda. Note: the outflow tibial artery can be treated concomitantly. Similarly, the common femoral artery can be treated concomitantly, either with open endarterectomy and patch angioplasty or with endovascular methods. However, the index lesion cannot be contiguous with either the common femoral artery or the tibial trifurcation.
• •2. 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
• •3. Inadequate distal outflow defined as no patent tibial arteries (\>50% stenosis). The outflow vessel can be established at the time of primary treatment
• •4. Use of adjunctive therapies other than angioplasty. Chocolate balloons and/or scoring balloons are allowed, if used below reference diameter.