Diamondback in Peripheral Vascular Disease

Stopped early · Not applicable

Conditions studied: Peripheral Vascular Diseases, Critical Limb Ischemia

In brief

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).

Key facts

Study ID

NCT03455374

Run by

Arkansas Heart Hospital

People needed

10

Starts

2017-08-08

Expected to finish

2019-05-13

Last updated by the study team

2019-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• Concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse).

Where it is running

• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Arkansas Site Management Services LLC — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.