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Summary

for people ages 35 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Details

Peripheral artery disease (PAD) affects at least 12 million Americans annually with more than half a million patients undergoing an endovascular or surgical revascularization procedure in order to treat the disease. Unfortunately, about two-thirds of patients still have blockages in the leg arteries, even after these procedures.

Advances in Magnetic resonance imaging (MRI) offer promise for understanding the mechanism of failure through insights into vessel wall composition, remodeling, and inflammation. Restenosis has a known relationship to inflammation. Advances in micro-catheter technologies offer the ability to deliver anti-inflammatory medications such as Dexamethasone (DEX) directly to the adventitia and advances in drug delivery on balloon surfaces to deliver paclitaxel to the intima of the artery.

This study aims to investigate if patient-specific parameters affect angioplasty outcomes, if DEX has a biological effect on the vessel wall, and if this effect is through the reduction of inflammation.

Keywords

Peripheral Artery Disease Vascular Disease Critical Limb Ischemia angioplasty peripheral vascular disease atherosclerosis balloon angioplasty dexamethasone drug coated balloon paclitaxel walking claudication Dexamethasone acetate BB 1101

Eligibility

You can join if…

Open to people ages 35 years and up

Screening:

  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

Procedural Criteria:

  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.

You CAN'T join if...

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
  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.

Procedural Criteria:

  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.

Locations

  • University of Washington accepting new patients
    Seattle, Washington, 98104, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02807779
Phase
Phase 4
Lead Scientist
Warren Gasper
Study Type
Interventional
Last Updated
June 1, 2017
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