Status:
COMPLETED
Atherectomy By Laser Ablation With Turbo-Elite
Lead Sponsor:
Spectranetics Corporation
Conditions:
Peripheral Arterial Disease
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 sizi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02307370
Start Date
December 1 2014
End Date
November 1 2016
Last Update
August 27 2021
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