ABLATE: Atherectomy By Laser Ablation With Turbo-Elite
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 |
---|---|---|
|
N/A |
Study Design
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
- 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.
- 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
- 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.
- Characterization of Adjunctive Therapy Use [Day 1]
Adjunctive therapy use will be characterized by frequencies.
- 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.
- 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.
- 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
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.- D024204
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
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%
|
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%
|
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)
|
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%
|
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)
|
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
|
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
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 |
nicolas.aguirre@philips.com |
- D024204