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

Trial Summary

This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the leg.

Eligibility

     1. Male or non-pregnant female ≥ 35 years of age
     2. Atherosclerotic, infrainguinal PAD
     3. Rutherford Clinical Category 2-6
     4. Stenosis detected by radiology that in the clinicians opinion is the reason for the
         PAD symptom
     5. Patient is willing to provide informed consent and comply with the required follow up
         visits, testing schedule, and medication regimen
     1. Successful angioplasty of the target lesion or portion of the target lesion defined as
         ≤30% residual lumen stenosis compared with adjacent non-diseased lumen diameter,
         without flow-limiting dissection
     2. De novo atherosclerotic lesion qualifying for angioplasty
     3. >50% diameter stenosis between the superficial femoral and/or popliteal artery
         (between the profunda and tibioperoneal trunk)
     4. Reference vessel diameter ≥3 mm and ≤ 8mm
     5. Successful wire crossing of lesion
     6. A patent artery proximal to the index lesion. Concomitant inflow procedures including
         open femoral artery endarterectomy or stenting of the iliac arteries is permissible.
     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
     7. Previous or planned surgical or interventional procedure within 30 days of index
         procedure
     8. Chronic renal insufficiency with eGFR < 45
     9. Prior bypass surgery, stenting, atherectomy or angioplasty of the target lesion
     10. Inability to take required study medications
     11. Contra-indication or known hypersensitivity to dexamethasone sodium phosphate,
         contrast media, gadolinium, or 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 receiving long-term oral steroids for unrelated condition. This does not
         include inhaled steroids for bronchial diseases.
     1. Lesions extending into the trifurcation or above the profunda. Note the outflow can be
         treated concomitantly. Similarly the common femoral artery can be treated
         concomitantly with either an open endarterectomy and patch angioplasty or by
         endovascular methods. However the index lesion cannot be contiguous with either the
         CFA or the trifurcation.
     2. Circumferential calcification at index lesion, which in the judgment of the
         investigator would prevent penetration of the microinfusion catheter needle through
         the vessel wall
     3. Inadequate distal outflow defined as absence of at least one patent tibial artery (no
         lesion >50% stenosis) with flow into the foot. The outflow vessel can be established
         at the time of primary treatment
     4. Use of adjunctive therapies other than angioplasty. The Chocolate balloon and other
         scoring balloons are allowed however stay below reference diameter.

Detailed Description

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.