Atherectomy By Laser Ablation With Turbo-Elite (ABLATE)

Spectranetics

Status

Completed

Conditions

Peripheral Vascular Disease

Peripheral Arterial Disease

Treatments

Device: Turbo-Elite Laser Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT02307370

D024204

Details and patient eligibility

About

The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

PAD with Rutherford Class 1-4
Patient is able to walk unassisted or with non-motorized assistive devices.
Documented PAD by ABI <0.9 or previous intervention with reoccurrence of symptoms
Documented stenosis by duplex ≥50%

Exclusion criteria

Patient is pregnant or breast feeding.
Evidence of Acute Limb Ischemia within 7 days prior to procedure.
CVA < 60 days prior to procedure.
MI < 60 days prior to procedure.
Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up.
Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
Serum creatinine ≥ 2.5 mg/dL (unless dialysis-dependent) within one day prior to procedure.
Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint.
Previously identified severe calcium in the vessel.