ABLATE: Atherectomy By Laser Ablation With Turbo-Elite

Sponsor
Spectranetics Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02307370
Collaborator
(none)
44
1
23

Study Details

Study Description

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%.

Condition or Disease Intervention/Treatment Phase
  • Device: Turbo-Elite Laser Catheter
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Atherectomy By Laser Ablation With Turbo-Elite
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Turbo-Elite Atherectomy

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

Outcome Measures

Primary Outcome Measures

  1. Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis [Day 1]

    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.

  2. Primary Safety Endpoint is Freedom From Major Adverse Event (MAE) [30 day follow-up]

    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.

Secondary Outcome Measures

  1. Final Procedure Residual Stenosis After All Therapy [Day 1]

    A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure.

  2. Characterization of Adjunctive Therapy Use [Day 1]

    Adjunctive therapy use will be characterized by frequencies.

  3. Ankle-Brachial Index (ABI) Change From Baseline to 30 Days. [Baseline and 30 Days post-procedure]

    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.

  4. Rutherford Class (RCC) Change [Baseline and 30 days of procedure]

    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.

  5. Freedom From Target Lesion Revascularization (TLR) Through 180 Days. [Day 180 (6 Months)]

    Freedom from target lesion revascularization (TLR) through 180 days post procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Spectranetics Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT02307370
Other Study ID Numbers:
  • D024204
First Posted:
Dec 4, 2014
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Turbo-Elite Atherectomy
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
Period Title: Overall Study
STARTED 44
30 Day Follow-up 40
180 Day Patient Telephone Contact 25
COMPLETED 25
NOT COMPLETED 19

Baseline Characteristics

Arm/Group Title Turbo-Elite Atherectomy
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
Overall Participants 43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
69.3
(10.7)
Sex: Female, Male (Count of Participants)
Female
20
46.5%
Male
23
53.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
8
18.6%
Not Hispanic or Latino
35
81.4%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
2
4.7%
White
41
95.3%
More than one race
0
0%
Unknown or Not Reported
0
0%
Weight (kg) (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]
82.8
(20.6)
Height (cm) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]
168.0
(9.1)
Medical History (Count of Participants)
History of Hypertension
39
90.7%
History of Hyperlipidemia
40
93%
History of Diabetes Mellitus
21
48.8%
History of Coronary Artery Disease
26
60.5%
History of Cebrovascular Accident
2
4.7%
Smoking Status (Count of Participants)
Never
8
18.6%
Current
9
20.9%
Stopped
26
60.5%

Outcome Measures

1. Primary Outcome
Title Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis
Description 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.
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
The analysis set is composed of 43 patients, data for primary efficacy analysis was available only for 42 participants.
Arm/Group Title Turbo-Elite Atherectomy
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
Measure Participants 42
Count of Participants [Participants]
39
90.7%
2. Primary Outcome
Title Primary Safety Endpoint is Freedom From Major Adverse Event (MAE)
Description 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.
Time Frame 30 day follow-up

Outcome Measure Data

Analysis Population Description
Although 40 participants completed 30 day follow-up, data was only available for 39 participants
Arm/Group Title Turbo-Elite Atherectomy
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
Measure Participants 39
Count of Participants [Participants]
38
88.4%
3. Secondary Outcome
Title Final Procedure Residual Stenosis After All Therapy
Description A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure.
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Turbo-Elite Atherectomy
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
Measure Participants 43
Mean (Standard Deviation) [Final Residual Stenosis % Per Site]
12.7
(13.1)
4. Secondary Outcome
Title Characterization of Adjunctive Therapy Use
Description Adjunctive therapy use will be characterized by frequencies.
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Turbo-Elite Atherectomy
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
Measure Participants 43
Turbo-Tandem (atherectomy laser)
0
0%
Standard Balloon Angioplasty
23
53.5%
Drug Coated Balloon Angioplasty
20
46.5%
Stenting
14
32.6%
5. Secondary Outcome
Title Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.
Description 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.
Time Frame Baseline and 30 Days post-procedure

Outcome Measure Data

Analysis Population Description
Although 43 patients were part of the analysis set, ABI is one of the most often missed assessments during baseline and the follow-up period. Only 40 participants had available ABI data.
Arm/Group Title Turbo-Elite Atherectomy
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
Measure Participants 40
Screening
0.7
(0.2)
30-day
0.9
(0.3)
Change from Screening to 30 days
0.3
(0.3)
6. Secondary Outcome
Title Rutherford Class (RCC) Change
Description 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.
Time Frame Baseline and 30 days of procedure

Outcome Measure Data

Analysis Population Description
Refer to participant flow.
Arm/Group Title Turbo-Elite Atherectomy (Screening) Turbo-Elite Atherectomy (30-day Follow-up)
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
Measure Participants 43 40
Rutherford Class 0
0
0%
17
NaN
Rutherford Class 1
0
0%
11
NaN
Rutherford Class 2
2
4.7%
5
NaN
Rutherford Class 3
33
76.7%
7
NaN
Rutherford Class 4
8
18.6%
0
NaN
Rutherford Class 5
0
0%
0
NaN
Rutherford Class 6
0
0%
0
NaN
7. Secondary Outcome
Title Freedom From Target Lesion Revascularization (TLR) Through 180 Days.
Description Freedom from target lesion revascularization (TLR) through 180 days post procedure
Time Frame Day 180 (6 Months)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Turbo-Elite Atherectomy
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
Measure Participants 43
Count of Participants [Participants]
40
93%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Turbo-Elite Atherectomy
Arm/Group Description Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
All Cause Mortality
Turbo-Elite Atherectomy
Affected / at Risk (%) # Events
Total 5/43 (11.6%)
Serious Adverse Events
Turbo-Elite Atherectomy
Affected / at Risk (%) # Events
Total 14/43 (32.6%)
Cardiac disorders
Myocardial Infarction 1/43 (2.3%) 1
Stroke 1/43 (2.3%) 1
Other - Cardiac 2/43 (4.7%) 3
Respiratory, thoracic and mediastinal disorders
Other - Respiratory 3/43 (7%) 3
Vascular disorders
Pseudoaneurysm 1/43 (2.3%) 1
Arterial Dissection 1/43 (2.3%) 1
Restenosis - Target Lesion 3/43 (7%) 3
Restenosis - Target Vessel 1/43 (2.3%) 1
Restenosis - Non-Target Limb 5/43 (11.6%) 5
Restenosis - Non-Target Vessel 1/43 (2.3%) 1
Other (Not Including Serious) Adverse Events
Turbo-Elite Atherectomy
Affected / at Risk (%) # Events
Total 2/43 (4.7%)
Injury, poisoning and procedural complications
Embolism 1/43 (2.3%) 1
Vascular disorders
Arterial Perforation 1/43 (2.3%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Nicolas Aguirre, Senior Manager, Clinical Operations
Organization Spectranetics, LLC now a part of Philips Image Guided Therapy Devices
Phone 612-297-6655
Email nicolas.aguirre@philips.com
Responsible Party:
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT02307370
Other Study ID Numbers:
  • D024204
First Posted:
Dec 4, 2014
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021