Trial Outcomes & Findings for Atherectomy By Laser Ablation With Turbo-Elite (NCT NCT02307370)
NCT ID: NCT02307370
Last Updated: 2021-08-27
Results Overview
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.
COMPLETED
NA
44 participants
Day 1
2021-08-27
Participant Flow
Participant milestones
| Measure |
Turbo-Elite Atherectomy
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
30 Day Follow-up
|
40
|
|
Overall Study
180 Day Patient Telephone Contact
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Turbo-Elite Atherectomy
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Declined Addendum ICF
|
6
|
|
Overall Study
No response during telephone contact
|
5
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Atherectomy By Laser Ablation With Turbo-Elite
Baseline characteristics by cohort
| Measure |
Turbo-Elite Atherectomy
n=43 Participants
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 10.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Weight (kg)
|
82.8 kg
STANDARD_DEVIATION 20.6 • n=93 Participants
|
|
Height (cm)
|
168.0 cm
STANDARD_DEVIATION 9.1 • n=93 Participants
|
|
Medical History
History of Hypertension
|
39 Participants
n=93 Participants
|
|
Medical History
History of Hyperlipidemia
|
40 Participants
n=93 Participants
|
|
Medical History
History of Diabetes Mellitus
|
21 Participants
n=93 Participants
|
|
Medical History
History of Coronary Artery Disease
|
26 Participants
n=93 Participants
|
|
Medical History
History of Cebrovascular Accident
|
2 Participants
n=93 Participants
|
|
Smoking Status
Never
|
8 Participants
n=93 Participants
|
|
Smoking Status
Current
|
9 Participants
n=93 Participants
|
|
Smoking Status
Stopped
|
26 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The analysis set is composed of 43 patients, data for primary efficacy analysis was available only for 42 participants.
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.
Outcome measures
| Measure |
Turbo-Elite Atherectomy
n=42 Participants
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
Turbo-Elite Atherectomy (30-day Follow-up)
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|---|
|
Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis
|
39 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 day follow-upPopulation: Although 40 participants completed 30 day follow-up, data was only available for 39 participants
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.
Outcome measures
| Measure |
Turbo-Elite Atherectomy
n=39 Participants
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
Turbo-Elite Atherectomy (30-day Follow-up)
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|---|
|
Primary Safety Endpoint is Freedom From Major Adverse Event (MAE)
|
38 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure.
Outcome measures
| Measure |
Turbo-Elite Atherectomy
n=43 Participants
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
Turbo-Elite Atherectomy (30-day Follow-up)
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|---|
|
Final Procedure Residual Stenosis After All Therapy
|
12.7 Final Residual Stenosis % Per Site
Standard Deviation 13.1
|
—
|
SECONDARY outcome
Timeframe: Day 1Adjunctive therapy use will be characterized by frequencies.
Outcome measures
| Measure |
Turbo-Elite Atherectomy
n=43 Participants
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
Turbo-Elite Atherectomy (30-day Follow-up)
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|---|
|
Characterization of Adjunctive Therapy Use
Stenting
|
14 Participants
|
—
|
|
Characterization of Adjunctive Therapy Use
Turbo-Tandem (atherectomy laser)
|
0 Participants
|
—
|
|
Characterization of Adjunctive Therapy Use
Standard Balloon Angioplasty
|
23 Participants
|
—
|
|
Characterization of Adjunctive Therapy Use
Drug Coated Balloon Angioplasty
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 30 Days post-procedurePopulation: 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.
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.
Outcome measures
| Measure |
Turbo-Elite Atherectomy
n=40 Participants
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
Turbo-Elite Atherectomy (30-day Follow-up)
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|---|
|
Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.
Screening
|
0.7 ratio
Standard Deviation 0.2
|
—
|
|
Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.
30-day
|
0.9 ratio
Standard Deviation 0.3
|
—
|
|
Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.
Change from Screening to 30 days
|
0.3 ratio
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and 30 days of procedurePopulation: Refer to participant flow.
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.
Outcome measures
| Measure |
Turbo-Elite Atherectomy
n=43 Participants
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
Turbo-Elite Atherectomy (30-day Follow-up)
n=40 Participants
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|---|
|
Rutherford Class (RCC) Change
Rutherford Class 0
|
0 Participants
|
17 Participants
|
|
Rutherford Class (RCC) Change
Rutherford Class 1
|
0 Participants
|
11 Participants
|
|
Rutherford Class (RCC) Change
Rutherford Class 4
|
8 Participants
|
0 Participants
|
|
Rutherford Class (RCC) Change
Rutherford Class 5
|
0 Participants
|
0 Participants
|
|
Rutherford Class (RCC) Change
Rutherford Class 6
|
0 Participants
|
0 Participants
|
|
Rutherford Class (RCC) Change
Rutherford Class 2
|
2 Participants
|
5 Participants
|
|
Rutherford Class (RCC) Change
Rutherford Class 3
|
33 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 180 (6 Months)Freedom from target lesion revascularization (TLR) through 180 days post procedure
Outcome measures
| Measure |
Turbo-Elite Atherectomy
n=43 Participants
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
Turbo-Elite Atherectomy (30-day Follow-up)
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|---|
|
Freedom From Target Lesion Revascularization (TLR) Through 180 Days.
|
40 Participants
|
—
|
Adverse Events
Turbo-Elite Atherectomy
Serious adverse events
| Measure |
Turbo-Elite Atherectomy
n=43 participants at risk
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|
|
Vascular disorders
Pseudoaneurysm
|
2.3%
1/43 • Number of events 1
|
|
Vascular disorders
Arterial Dissection
|
2.3%
1/43 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
2.3%
1/43 • Number of events 1
|
|
Vascular disorders
Restenosis - Target Lesion
|
7.0%
3/43 • Number of events 3
|
|
Vascular disorders
Restenosis - Target Vessel
|
2.3%
1/43 • Number of events 1
|
|
Vascular disorders
Restenosis - Non-Target Limb
|
11.6%
5/43 • Number of events 5
|
|
Vascular disorders
Restenosis - Non-Target Vessel
|
2.3%
1/43 • Number of events 1
|
|
Cardiac disorders
Stroke
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Other - Respiratory
|
7.0%
3/43 • Number of events 3
|
|
Cardiac disorders
Other - Cardiac
|
4.7%
2/43 • Number of events 3
|
Other adverse events
| Measure |
Turbo-Elite Atherectomy
n=43 participants at risk
Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
|
|---|---|
|
Vascular disorders
Arterial Perforation
|
2.3%
1/43 • Number of events 1
|
|
Injury, poisoning and procedural complications
Embolism
|
2.3%
1/43 • Number of events 1
|
Additional Information
Nicolas Aguirre, Senior Manager, Clinical Operations
Spectranetics, LLC now a part of Philips Image Guided Therapy Devices
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place