Vascular & Endovascular Surgery »  Research »  Clinical Research »  Clinical Trials »  15-17251 (INVADER MRI)

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

Official Title:

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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 4 Interventional 35 Years and older University of California, San Francisco 15-17251
1R01HL128816-01
NCT02807779
Enrolling patients

Study Design:


Principal Investigator

Assistant Professor of Clinical Surgery
Division of Vascular and Endovascular Surgery
Acting Chief, Section of Vascular Surgery,
San Francisco VA Medical Center
Director, Vascular Integrated Physiology and
Experimental Therapeutics (ViperX)

Clinical Research Coordinator

San Francisco VA Medical Center
(415) 221-4810 Ext. 2-4708 Phone
(415) 379-5534 Fax

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

Inclusion Criteria:
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.
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
     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.

Detailed Description

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.

Important

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.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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