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Diamondback in Peripheral Vascular Disease

NCT03455374 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-06-27

No results posted yet for this study

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).

Conditions

  • Peripheral Vascular Diseases
  • Critical Limb Ischemia

Interventions

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Arkansas Heart Hospital

    lead OTHER

Principal Investigators

  • Mehmet Cilingiroglu, MD · Arkansas Heart Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-08
Primary Completion
2019-05-13
Completion
2019-05-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03455374 on ClinicalTrials.gov