Peripheral Artery Disease
Conditions
Brief summary
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature. This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.
Interventions
DEVICEPathway PV Atherectomy System
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in lower limb peripheral vasculature during percutaneous interventional procedures.
Sponsors
Pathway Medical Technologies Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented symptomatic atherosclerotic peripheral vascular disease * Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries * The patient has been informed of the nature of the study and has provided informed consent * The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits
Exclusion criteria
* Target lesion is located in the iliac artery. * Target lesion stenosis is \< 70%. * Interventional treatment is intended for in-stent restenosis at the peripheral vascular site. * Patient is unable to participate for the duration of the study. * Patient is currently participating or has participated in a study with another investigational medical device or medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events (MAEs) Within 30 Days | 30 days | Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Rutherford Classification Score at 6 Months | 6 months | Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg) |
| Average Ankle Brachial Index (ABI) at 6 Months | 6 months | Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5) |
| Freedom From Target Lesion Revascularization (TLR) at 6 Months | 6 months | Number of patients that did not require target lesion revascularization 6 months after index procedure. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients Patients meeting eligibility criteria and enrolled in the study. | 172 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missed Visit | 8 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 134 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age Continuous | 71.9 years STANDARD_DEVIATION 8.4 |
| Sex: Female, Male Female | 88 Participants |
| Sex: Female, Male Male | 84 Participants |
Outcome results
Primary
Major Adverse Events (MAEs) Within 30 Days
Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.
Time frame: 30 days
Population: Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Major Adverse Events (MAEs) Within 30 Days | 2 Participants |
Secondary
Average Ankle Brachial Index (ABI) at 6 Months
Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)
Time frame: 6 months
Population: Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Average Ankle Brachial Index (ABI) at 6 Months | 0.77 units on scale | Standard Deviation 0.26 |
Secondary
Average Rutherford Classification Score at 6 Months
Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)
Time frame: 6 months
Population: Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Average Rutherford Classification Score at 6 Months | 1.5 Score on scale | Standard Deviation 1.4 |
Secondary
Freedom From Target Lesion Revascularization (TLR) at 6 Months
Number of patients that did not require target lesion revascularization 6 months after index procedure.
Time frame: 6 months
Population: Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Freedom From Target Lesion Revascularization (TLR) at 6 Months | 147 participants |