Atherectomy By Laser Ablation With Turbo-Elite

Peripheral Arterial Disease Clinical Trial

— ABLATE  

Official title:

Atherectomy By Laser Ablation With Turbo-Elite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307370
• Other study ID #: D024204
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: November 2016

Study information

• Verified date: August 2021
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Turbo-Elite Laser Catheter
Application of laser energy to remove blockage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Final Procedure Residual Stenosis After All Therapy	A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure.	Day 1
Secondary	Characterization of Adjunctive Therapy Use	Adjunctive therapy use will be characterized by frequencies.	Day 1
Secondary	Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.	ABI will be assessed at baseline and within 30 days of the procedure. The ABI is calculated ratio of the highest ankle blood pressure to the highest arm blood pressure. The ABI is a non-invasive tool for screening for Peripheral Artery Disease.	Baseline and 30 Days post-procedure
Secondary	Rutherford Class (RCC) Change	Rutherford Class (RCC) will be assessed at baseline and within 30 days of the procedure. The Rutherford-Becker Clinical Categories (RCC) are a classification system of chronic limb ischemia ranging from 0 (asymptomatic; no hemodynamically significant occlusive disease) to 6 (major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable). Lower categories represent better clinical status.	Baseline and 30 days of procedure
Secondary	Freedom From Target Lesion Revascularization (TLR) Through 180 Days.	Freedom from target lesion revascularization (TLR) through 180 days post procedure	Day 180 (6 Months)