Diamondback in Peripheral Vascular Disease

NCT03455374 | Terminated FDA Device

• 1 other identifier: 20171653
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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).

Conditions

Peripheral Vascular Diseases; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Change in luminal area gain, measured in mm, in treated segment of the vessel wall

  Luminal area gain in the treated segment of the vessel wall between pre-and post-atherectomy OCT images.

  Baseline and 7 month

Secondary Outcomes (6)

• Atherectomy OCT Analysis-plaque volume

  0 and 7 months

• Atherectomy OCT Analysis-fibrous tissue

  0 and 7 months

• Atherectomy OCT Analysis- new dissections

  0 and 7 months

• Atherectomy OCT Analysis-new injuries

  0 and 7 months

• Atherectomy images Analysis-Luminal area loss

  0 and 7 months

Study Arms (1)

Treatment with CSI atherectomy device

EXPERIMENTAL

removal of the plaque from vessel wall by optical coherence tomography

Device: Treatment with CSI atherectomy device

Interventions

Treatment with CSI atherectomy device 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.

Treatment with CSI atherectomy device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arkansas Heart Hospital: lead
• Abbott Medical Devices: collaborator

Study Sites (2)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Arkansas Site Management Services LLC

Little Rock, Arkansas, 72211, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Mehmet Cilingiroglu, MD

  Arkansas Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: March 6, 2018
• Study Start: August 8, 2017
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)