Peripheral Arterial Disease
Conditions
Keywords
PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream
Brief summary
To investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease in the common femoral, superficial femoral or popliteal arteries using intravascular ultrasound (IVUS).
Interventions
to perform atherectomy on calcified lesions
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. The patient is ≥ 18 years of age. 2. Patient has claudication determined to be due to femoropopliteal lesion(s) requiring revascularization. 3. The target lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries. 4. The reference vessel lumen (proximal to target lesion) is ≥ 3.0mm. 5. The patient is an acceptable candidate for percutaneous intervention using the Jetstream G3 System in accordance with its labeled indications and instructions for use. 6. The patient has signed approved informed consent. 7. Moderate or severe vessel obstructive intraluminal calcification as demonstrated by IVUS and angiography.
Exclusion criteria
1. Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent. 2. Patient is unable to take appropriate anti-platelet therapy. 3. Patient has no distal runoff vessels. 4. Deep wall calcium. 5. Interventional treatment is intended for in-stent restenosis at the peripheral vascular site. 6. Patient has target vessel with moderate or severe angulation (e.g., \>30 degrees) or tortuosity at the treatment segment. 7. Patient has a history of coagulopathy or hypercoagulable bleeding disorder. 8. Patient is receiving hemodialysis or has impaired renal function (creatinine is \> 2.5 mg/dl) at the time of treatment. 9. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months. 10. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days. 11. Patient is pregnant or nursing a child. 12. Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G3 System. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Luminal Area Change | Day 0 | lumen area change as measured by intravascular ultrasound (IVUS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjunctive Therapy Use | Day 0 | — |
| Residual Diameter Stenosis | Day 0 | lumen diameter stenosis change post-atherectomy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm subjects with calcified peripheral arterial lesions determined by intravascular ultrasound | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | did not meet IVUS criteria | 29 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Luminal Area Change
lumen area change as measured by intravascular ultrasound (IVUS)
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-atherectomy | Luminal Area Change | 5.1 mm^2 | Standard Deviation 2.8 |
| Post-atherectomy | Luminal Area Change | 8.3 mm^2 | Standard Deviation 2.6 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Adjunctive Therapy Use
Time frame: Day 0
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-atherectomy | Adjunctive Therapy Use | Percutaneous Transluminal Angioplasty | 62 percentage of participants |
| Pre-atherectomy | Adjunctive Therapy Use | Stent | 31 percentage of participants |
| Pre-atherectomy | Adjunctive Therapy Use | Other devices or procedures | 8 percentage of participants |
Secondary
Residual Diameter Stenosis
lumen diameter stenosis change post-atherectomy
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-atherectomy | Residual Diameter Stenosis | -37 percentage change | Standard Deviation 13 |