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Diamondback in Peripheral Vascular Disease (DIAMOND-PAD)

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ClinicalTrials.gov Identifier: NCT03455374
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Cardiovascular Systems Inc
Information provided by (Responsible Party):
Arkansas Heart Hospital

Brief Summary:
This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if they have claudication and/or critical limb ischemia, and identifiable PAD disease with moderate to severe calcification on Computer Tomography Angiogram (PCA) or peripheral angiogram requiring percutaneous peripheral intervention (PPI).

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Critical Limb Ischemia Device: Treatment with CSI atherectomy device Not Applicable

Detailed Description:

Orbital atherectomy (OA) is one of the most commonly used modalities for the treatment of obstructive femoral-popliteal PAD, especially in patients with large and calcified atherosclerotic plaques, either as stand alone or with subsequent drug-coated balloon angioplasty or stent implantation. These atherectomy procedures were primarily guided by peripheral angiography which has significant resolution limitations in regards to the plaque morphology and characteristics such as extent of calcification, and how deep the cuts are made in the vessel wall.

Optical coherence tomography (OCT) has recently emerged as a novel imaging modality. OCT imaging has been used both in coronary as well as in peripheral circulation extensively with no significant device related adverse effects. Previous research has shown the feasibility and safety of OCT use for peripheral artery imaging and its use in plaque characterization. The hypothesis for this study is that; use of diamond back atherectomy device will lead to effective removal of plaque in moderate to heavily calcified arteries without damaging deep into the adventitia or EEL or the adjacent healthy vessel wall and thus will lead to a favorable vascular response during follow up.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diamondback Atherectomy With OCT Visualization for Calcified PAD Lesions for Calcified Peripheral Vascular Disease Lesions
Actual Study Start Date : August 8, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with CSI atherectomy device
removal of the plaque from vessel wall by optical coherence tomography
Device: Treatment with CSI atherectomy device
Following peripheral angiography, patients with significant SFA or below the knee artery disease (≥ 50%) or total occlusions (100%) will have a baseline OCT imaging of the target vessel and the lesion be treated with proper size CSI burr. Repeat OCT imaging will be performed after CSI. Drug eluting balloon angioplasty may be performed in discretion of the operator. If DEB is used, a final OCT imaging will be performed to assess lesion expansion and possible dissections. Balloon sizing will be based on 1:1 vessel ratio with the length covering from minimally diseased distal segment to minimally diseased proximal segment. We will try to avoid use of stents.




Primary Outcome Measures :
  1. Change in luminal area gain, measured in mm, in treated segment of the vessel wall [ Time Frame: Baseline and 7 month ]
    Luminal area gain in the treated segment of the vessel wall between pre-and post-atherectomy OCT images.


Secondary Outcome Measures :
  1. Atherectomy OCT Analysis-plaque volume [ Time Frame: 0 and 7 months ]
    Changes in calcified total plaque volume as compare to baseline.

  2. Atherectomy OCT Analysis-fibrous tissue [ Time Frame: 0 and 7 months ]
    Changes in fibrous tissue amount as compared to baseline

  3. Atherectomy OCT Analysis- new dissections [ Time Frame: 0 and 7 months ]
    Number of new dissections present at 7 months as compare to baseline

  4. Atherectomy OCT Analysis-new injuries [ Time Frame: 0 and 7 months ]
    Percentage of cross-sectional images with new injury to the adventitia or EEL as compared to baseline

  5. Atherectomy images Analysis-Luminal area loss [ Time Frame: 0 and 7 months ]
    Change in Luminal area loss as measure by calcified plaque volume as well as by the presence of lipid and fibrous tissue as compared to baseline

  6. Atherectomy images Analysis-persistent dissections [ Time Frame: 0 and 7 months ]
    Percentage of cross-sectional images with persistent dissections as compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Patient with lower extremity claudication and PAD due to significant SFA or below the knee stenosis (50%≤99%) or total occlusions (100%) that affects the quality of life despite medical therapy.

    • Evidence of significant SFA or below the knee disease involving the most symptomatic limb by noninvasive vascular testing with the use of the following:

      • ABI: <0.9 (If ABI>1.4, SFA systolic acceleration time should be > 140 milliseconds);
      • TBI: <0.6;
      • Computed Tomographic Angiography (CTA) confirming at least a 50% SFA stenosis with moderate to severe calcification; or
      • Magnetic Resonance Angiography (MRA) confirming at least a 50% SFA or below the knee stenosis with moderate to severe calcification.
    • At least one patent, non-treated below the knee vessel.
    • Male and female patients that are ≥ 18 years of age.
    • Subject has been advised of the beneficial effects of smoking cessation and regular exercise but must not be in the process of changing their smoking status at the time of screening. Patients may resume or increase exercising as an effect of post procedurally improved lower limb perfusion.
    • Peak Walking Time (PWT) limited only by claudication.
    • Willingness to participate in the study, documented by signed, written informed consent.

Exclusion Criteria:

  • • Planned amputation.

    • Any planned/scheduled revascularization procedures ≤ 30 days after baseline procedure.
    • Prior lower extremity revascularization ≤ 30 days before baseline procedure.
    • The target lesion is an in-stent restenosis.
    • Infra-popliteal disease involving the last remaining vessel.
    • Patients with a creatinine clearance < 30mL/min.
    • Patients with known bleeding disorders.
    • Patients with known active pathological bleeding.
    • Patients with known hypersensitivity to acetylsalicylic acid, clopidogrel bisulfate, ticagrelor, Aspirin, or other antiplatelets/anticoagulants.
    • Patients with known history of intracranial hemorrhage at any time, GI bleed in the past 6 months, or major surgery within the past 30 days.
    • Patients with known ischemic stroke during the past 3 months.
    • Patients with known severe liver disease.
    • Patient with known history of congestive heart failure (CHF) with an LVEF of < 30%.
    • Patients considered being at risk of bradycardic events unless treated with a permanent pacemaker.
    • Female patients with known pregnancy, breast feeding, or intend to become pregnant during the study period (all female patients 55 years and younger, without a history of hysterectomy must have a pregnancy test prior to PPI at baseline and at 6 months).
    • Concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455374


Contacts
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Contact: Leybi Ramirez-Kelly, MD, MPH 501-748-8495 leybi.ramirez-kelly@arheart.com
Contact: Mary Catherine Faulkner, RN, BSN 501-690-2339 marycatherine.faulkner@arheart.com

Locations
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United States, Arkansas
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Mary Catherine Faulkner    501-690-2339    marycatherine.faulkner@arheart.com   
Contact: Leybi Ramirez-Kelly, MD, MPH    501-748-8495    leybi.ramirez_kelly@arheart.com   
Principal Investigator: Mehmet Cilingiroglu, M.D.         
Arkansas Site Management Services LLC Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Mary Catherine Faulkner, RN, BSN    501-748-8421    marycatherine.faulkner@arheart.com   
Contact: Leybi Ramirez-Kelly, MD, MPH    501-748-8495    leybi.ramirez_kelly@arheart.com   
Sponsors and Collaborators
Arkansas Heart Hospital
Cardiovascular Systems Inc
Investigators
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Principal Investigator: Mehmet Cilingiroglu, MD Arkansas Heart Hospital

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Responsible Party: Arkansas Heart Hospital
ClinicalTrials.gov Identifier: NCT03455374     History of Changes
Other Study ID Numbers: 20171653
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases