Atherectomy By Laser Ablation With Turbo-Elite

NCT02307370 | Completed Results FDA Device

• 1 other identifier: D024204
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis

  The primary efficacy endpoint target was a mean reduction in percent stenosis of greater than 20% in each study participating at the time of the procedure by Angiographic Core Lab assessment after Turbo-Elite use. A participant showing a mean reduction of 20% was considered a success for the primary efficacy endpoint.

  Day 1

• Primary Safety Endpoint is Freedom From Major Adverse Event (MAE)

  The primary safety endpoint target was 80% of study participant with freedom from a Major Adverse Event (MAE) through 30 day follow-up. A MAE was defined as: all cause death, major amputation in the target limb, or target lesion revascularization.

  30 day follow-up

Secondary Outcomes (5)

• Final Procedure Residual Stenosis After All Therapy

  Day 1

• Characterization of Adjunctive Therapy Use

  Day 1

• Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.

  Baseline and 30 Days post-procedure

• Rutherford Class (RCC) Change

  Baseline and 30 days of procedure

• Freedom From Target Lesion Revascularization (TLR) Through 180 Days.

  Day 180 (6 Months)

Study Arms (1)

Turbo-Elite Atherectomy

EXPERIMENTAL

Device: Turbo-Elite Laser Catheter

Interventions

Turbo-Elite Laser Catheter DEVICE

Application of laser energy to remove blockage

Turbo-Elite Atherectomy

Eligibility Criteria

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

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spectranetics Corporation: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Nicolas Aguirre, Senior Manager, Clinical Operations
• Organization: Spectranetics, LLC now a part of Philips Image Guided Therapy Devices

nicolas.aguirre@philips.com

612-297-6655

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 4, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2016
• Last Updated: August 27, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-08