Peripheral Artery Disease
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of the CLiRpath® Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger lumens for treatment within the superficial femoral and popliteal arteries above the knee.
Interventions
DEVICECLiRpath Photoablation System
Use of CLiRpath Laser Catheter to improve vessel lumen diameter.
Sponsors
Spectranetics Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Peripheral vascular disease Rutherford Classification 1, 2, or 3; 2. Eligible for revascularization of native vessel (PTA or bypass); 3. Willing and able to comply with the specified evaluations during hospitalization and all required follow-up examinations; 4. Written informed consent given before execution of study procedures; and 5. Age \> 18 and ≤ 85 years. Angiographic Inclusion Criteria 1. Reference vessel diameter \>/= 4.0 mm and ≤ 7.0 mm as determined by physician visual angiographic assessment of the most normally appearing vessel segment within 10 mm proximal AND 10 mm distal to the target segment. 2. Stenosis within the SFA and/or popliteal artery above the knee of \>/= 70% and \</= 100% DS (occlusion), as determined by visual angiographic assessment by the investigator at the time of the procedure and documented by angiography in at least two (2) orthogonal views. 3. At least 1.0 cm of visible SFA stump beyond the origin of the profunda artery. 4. Total lesion length \>/= 1.0 cm and ≤ 15.0 cm as determined by visual angiographic assessment at the time of the procedure, separate multiple lesions can be combined as two separate treatment areas as long as the sum total of all lesion lengths and/or treatment areas does not exceed 1.0 cm to 15.0 cm. 5. Patency (\< 50% DS) of at least one (1) infrapopliteal artery in continuity with the native femoropopliteal artery. \-
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laser Success | Measured at time of procedure | The primary efficacy endpoint is laser success, defined as achieving \>/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment. |
| Major Adverse Events | From discharge through the 6 month follow-up | The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | measured post discharge thorugh 12 Months follow-up | Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure |
| Assisted Primary Patency | Through 12 Months | Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion |
| Assisted Secondary Patency | Through 12 Month | Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site |
| Procedural Success | measured at time of procedure | Acute procedural success, defined as achievement of \</= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of \</=30%. |
| Rutherford Classification | Through 12 Months | Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst |
| Adverse Events | Through 12 Months | Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure. |
| Volumetric Plaque Reduction | measured at time of procedure | Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point. |
| Patients With >50% Stenosis Measured by Duplex Ultrasound | Through 12 Month | Percentage of patients with \>50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure). |
| Minimum and Maximum Lumen Diameters | measured at time of procedure | Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS). |
Participant flow
Recruitment details
Patients were recruited from investigator patient referral base. Recruitment occurred between November 2006 and March 2007
Pre-assignment details
Patients were screened for inclusion/exclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| Laser Treatment CLiRpath Photoablation Atherectomy System | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Laser Treatment |
|---|---|
| Age Continuous | 68.3 years STANDARD_DEVIATION 10.1 |
| Race/Ethnicity African American | 11 participants |
| Race/Ethnicity Hispanic or Latino | 5 participants |
| Race/Ethnicity Not Hispanic or Latino | 49 participants |
| Region of Enrollment United States | 65 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 65 |
| serious Total, serious adverse events | 11 / 65 |
Outcome results
Primary
Laser Success
The primary efficacy endpoint is laser success, defined as achieving \>/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.
Time frame: Measured at time of procedure
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser Treatment | Laser Success | 34.7 percent reduction | Standard Deviation 17.8 |
Comparison: Comparing to an expected value of 20% reduction from initial to post-laserp-value: 0.001t-test, 1 sided
Primary
Major Adverse Events
The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.
Time frame: From discharge through the 6 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser Treatment | Major Adverse Events | 0 events |
Secondary
Adverse Events
Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.
Time frame: Through 12 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Laser Treatment | Adverse Events | Procedure/24 hours | 10 events |
| Laser Treatment | Adverse Events | 30 days | 7 events |
| Laser Treatment | Adverse Events | 6 months | 15 events |
| Laser Treatment | Adverse Events | 12 months | 15 events |
| Laser Treatment | Adverse Events | Other | 31 events |
Secondary
Assisted Primary Patency
Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion
Time frame: Through 12 Months
Population: 65 at 30 days; 64 at 6 months; 63 at 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Laser Treatment | Assisted Primary Patency | 30 days; n=65 | 100 % pts free from assisted primary patency |
| Laser Treatment | Assisted Primary Patency | 6 months; n=64 | 85.9 % pts free from assisted primary patency |
| Laser Treatment | Assisted Primary Patency | 12 months; n=63 | 76.2 % pts free from assisted primary patency |
Secondary
Assisted Secondary Patency
Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site
Time frame: Through 12 Month
Population: 65 at 30 days; 64 at 6 months; 63 at 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Laser Treatment | Assisted Secondary Patency | 30 days; n=65 | 100 % pts free from secondary patency |
| Laser Treatment | Assisted Secondary Patency | 6 months; n=64 | 100 % pts free from secondary patency |
| Laser Treatment | Assisted Secondary Patency | 12 months; n=63 | 100 % pts free from secondary patency |
Secondary
Clinical Success
Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure
Time frame: measured post discharge thorugh 12 Months follow-up
Population: 65 patients at 30 days; 59 at 6 months; 46 at 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Laser Treatment | Clinical Success | 30 days; n=65 | 96.9 percent of patients |
| Laser Treatment | Clinical Success | 6 months; n=59 | 59.3 percent of patients |
| Laser Treatment | Clinical Success | 12 months; n=46 | 54.3 percent of patients |
Secondary
Minimum and Maximum Lumen Diameters
Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).
Time frame: measured at time of procedure
Population: Analysis per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laser Treatment | Minimum and Maximum Lumen Diameters | Post pilot channel max lumen diameter | 4.2 millimeters | Standard Deviation 1.1 |
| Laser Treatment | Minimum and Maximum Lumen Diameters | Post Turbo-Booster max lumen diameter | 5.1 millimeters | Standard Deviation 0.8 |
| Laser Treatment | Minimum and Maximum Lumen Diameters | Post pilot channel min lumen diameter | 1.9 millimeters | Standard Deviation 0.6 |
| Laser Treatment | Minimum and Maximum Lumen Diameters | Post Turbo-Booster min lumen diameter | 2.2 millimeters | Standard Deviation 0.8 |
Secondary
Patients With >50% Stenosis Measured by Duplex Ultrasound
Percentage of patients with \>50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).
Time frame: Through 12 Month
Population: per protocol; 65 patients at 30 days; 59 at 6 months and 46 at 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Laser Treatment | Patients With >50% Stenosis Measured by Duplex Ultrasound | 30 days; n=65 | 3.1 percent of patients |
| Laser Treatment | Patients With >50% Stenosis Measured by Duplex Ultrasound | 6 months; n=59 | 40.7 percent of patients |
| Laser Treatment | Patients With >50% Stenosis Measured by Duplex Ultrasound | 12 months; n=46 | 45.7 percent of patients |
Secondary
Procedural Success
Acute procedural success, defined as achievement of \</= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of \</=30%.
Time frame: measured at time of procedure
Population: Per protocol. All enrolled patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser Treatment | Procedural Success | 98.5 percent with </=30% RS |
Secondary
Rutherford Classification
Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst
Time frame: Through 12 Months
Population: 63 at baseline; 62 at 30days and 6 months; 63 at 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laser Treatment | Rutherford Classification | baseline; n=63 | 2.4 units on a scale of 0-6 | Standard Deviation 0.6 |
| Laser Treatment | Rutherford Classification | 30 days; n=62 | 1.0 units on a scale of 0-6 | Standard Deviation 0.8 |
| Laser Treatment | Rutherford Classification | 6 months; n=62 | 1.3 units on a scale of 0-6 | Standard Deviation 1.1 |
| Laser Treatment | Rutherford Classification | 12 months; n=63 | 1.3 units on a scale of 0-6 | Standard Deviation 0.9 |
Secondary
Volumetric Plaque Reduction
Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.
Time frame: measured at time of procedure
Population: Per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laser Treatment | Volumetric Plaque Reduction | Post pilot channel plaque volume | 200.8 millimeters cubed | Standard Deviation 61 |
| Laser Treatment | Volumetric Plaque Reduction | Post Turbo Booster plaque volume | 192.8 millimeters cubed | Standard Deviation 61.2 |
Post Hoc
Walking Impairment Questionare (WIQ)
Measures difficulty in walking before and after treatment. Defined by comparing the responses to a WIQ at pre-treatment with the responses at 30 days, six (6) months and 12 months post-procedure. Higher score is better (scale 0-100).
Time frame: measured at each follow-up period
Population: 65 patients at baseline and 30 days; 64 at 6 mo; 63 at 12 mo
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laser Treatment | Walking Impairment Questionare (WIQ) | baseline; n=65 | 45.6 units on a scale 0-100 | Standard Deviation 21.3 |
| Laser Treatment | Walking Impairment Questionare (WIQ) | 30 days; n=65 | 69.9 units on a scale 0-100 | Standard Deviation 23.7 |
| Laser Treatment | Walking Impairment Questionare (WIQ) | 6 months; n=64 | 64.7 units on a scale 0-100 | Standard Deviation 27.1 |
| Laser Treatment | Walking Impairment Questionare (WIQ) | 12 months; n=63 | 65.1 units on a scale 0-100 | Standard Deviation 25.3 |