Peripheral Arterial Disease, Peripheral Vascular Disease
Conditions
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%.
Interventions
DEVICETurbo-Elite Laser Catheter
Application of laser energy to remove blockage
Sponsors
Spectranetics Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Freedom From Target Lesion Revascularization (TLR) Through 180 Days. | Day 180 (6 Months) | Freedom from target lesion revascularization (TLR) through 180 days post procedure |
| 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. |
| Characterization of Adjunctive Therapy Use | Day 1 | Adjunctive therapy use will be characterized by frequencies. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Turbo-Elite Atherectomy Turbo-Elite Laser Catheter: Application of laser energy to remove blockage | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Declined Addendum ICF | 6 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | No response during telephone contact | 5 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Turbo-Elite Atherectomy |
|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height (cm) | 168.0 cm STANDARD_DEVIATION 9.1 |
| Medical History History of Cebrovascular Accident | 2 Participants |
| Medical History History of Coronary Artery Disease | 26 Participants |
| Medical History History of Diabetes Mellitus | 21 Participants |
| Medical History History of Hyperlipidemia | 40 Participants |
| Medical History History of Hypertension | 39 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 23 Participants |
| Smoking Status Current | 9 Participants |
| Smoking Status Never | 8 Participants |
| Smoking Status Stopped | 26 Participants |
| Weight (kg) | 82.8 kg STANDARD_DEVIATION 20.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 43 |
| other Total, other adverse events | 2 / 43 |
| serious Total, serious adverse events | 14 / 43 |
Outcome results
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.
Time frame: Day 1
Population: The analysis set is composed of 43 patients, data for primary efficacy analysis was available only for 42 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Turbo-Elite Atherectomy | Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis | 39 Participants |
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.
Time frame: 30 day follow-up
Population: Although 40 participants completed 30 day follow-up, data was only available for 39 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Turbo-Elite Atherectomy | Primary Safety Endpoint is Freedom From Major Adverse Event (MAE) | 38 Participants |
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.
Time frame: Baseline and 30 Days post-procedure
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Turbo-Elite Atherectomy | Ankle-Brachial Index (ABI) Change From Baseline to 30 Days. | Screening | 0.7 ratio | Standard Deviation 0.2 |
| Turbo-Elite Atherectomy | Ankle-Brachial Index (ABI) Change From Baseline to 30 Days. | 30-day | 0.9 ratio | Standard Deviation 0.3 |
| Turbo-Elite Atherectomy | Ankle-Brachial Index (ABI) Change From Baseline to 30 Days. | Change from Screening to 30 days | 0.3 ratio | Standard Deviation 0.3 |
Secondary
Characterization of Adjunctive Therapy Use
Adjunctive therapy use will be characterized by frequencies.
Time frame: Day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Turbo-Elite Atherectomy | Characterization of Adjunctive Therapy Use | Turbo-Tandem (atherectomy laser) | 0 Participants |
| Turbo-Elite Atherectomy | Characterization of Adjunctive Therapy Use | Standard Balloon Angioplasty | 23 Participants |
| Turbo-Elite Atherectomy | Characterization of Adjunctive Therapy Use | Drug Coated Balloon Angioplasty | 20 Participants |
| Turbo-Elite Atherectomy | Characterization of Adjunctive Therapy Use | Stenting | 14 Participants |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Turbo-Elite Atherectomy | Final Procedure Residual Stenosis After All Therapy | 12.7 Final Residual Stenosis % Per Site | Standard Deviation 13.1 |
Secondary
Freedom From Target Lesion Revascularization (TLR) Through 180 Days.
Freedom from target lesion revascularization (TLR) through 180 days post procedure
Time frame: Day 180 (6 Months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Turbo-Elite Atherectomy | Freedom From Target Lesion Revascularization (TLR) Through 180 Days. | 40 Participants |
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.
Time frame: Baseline and 30 days of procedure
Population: Refer to participant flow.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Turbo-Elite Atherectomy | Rutherford Class (RCC) Change | Rutherford Class 2 | 2 Participants |
| Turbo-Elite Atherectomy | Rutherford Class (RCC) Change | Rutherford Class 4 | 8 Participants |
| Turbo-Elite Atherectomy | Rutherford Class (RCC) Change | Rutherford Class 1 | 0 Participants |
| Turbo-Elite Atherectomy | Rutherford Class (RCC) Change | Rutherford Class 5 | 0 Participants |
| Turbo-Elite Atherectomy | Rutherford Class (RCC) Change | Rutherford Class 3 | 33 Participants |
| Turbo-Elite Atherectomy | Rutherford Class (RCC) Change | Rutherford Class 6 | 0 Participants |
| Turbo-Elite Atherectomy | Rutherford Class (RCC) Change | Rutherford Class 0 | 0 Participants |
| Turbo-Elite Atherectomy (30-day Follow-up) | Rutherford Class (RCC) Change | Rutherford Class 6 | 0 Participants |
| Turbo-Elite Atherectomy (30-day Follow-up) | Rutherford Class (RCC) Change | Rutherford Class 0 | 17 Participants |
| Turbo-Elite Atherectomy (30-day Follow-up) | Rutherford Class (RCC) Change | Rutherford Class 1 | 11 Participants |
| Turbo-Elite Atherectomy (30-day Follow-up) | Rutherford Class (RCC) Change | Rutherford Class 2 | 5 Participants |
| Turbo-Elite Atherectomy (30-day Follow-up) | Rutherford Class (RCC) Change | Rutherford Class 3 | 7 Participants |
| Turbo-Elite Atherectomy (30-day Follow-up) | Rutherford Class (RCC) Change | Rutherford Class 4 | 0 Participants |
| Turbo-Elite Atherectomy (30-day Follow-up) | Rutherford Class (RCC) Change | Rutherford Class 5 | 0 Participants |