Atherectomy By Laser Ablation With Turbo-Elite

NCT ID: NCT02307370

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-11-30

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 sizing of at least 50%.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Turbo-Elite Atherectomy

Group Type: EXPERIMENTAL

Turbo-Elite Laser Catheter

Intervention Type: DEVICE

Application of laser energy to remove blockage

Interventions

Turbo-Elite Laser Catheter

Application of laser energy to remove blockage

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectranetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

D024204

Identifier Type: -

Identifier Source: org_study_id