Peripheral Arterial Diseases
Conditions
Keywords
PAD, peripheral artery disease, atherectomy
Brief summary
The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.
Detailed description
* To observe the treatment effects of the Jetstream NAVITUS System in long, occluded, diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries. * To assess and quantify vessel patency 1 year post atherectomy treatment.
Interventions
Atherectomy
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is ≥ 18 years of age. * The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries. * The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm. * Evidence of ≥ 70% stenosis or occlusion confirmed by angiography. * Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course before the patient is considered as entered into the study. * Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled indications and instructions for use. * Lesion length ≥ 4cm. * Patient has a Rutherford category score of 1-3. * Patient has signed approved informed consent. * Patient is willing to comply with the follow-up evaluations at specified times.
Exclusion criteria
* Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent. * Patient is unable to take appropriate anti-platelet therapy. * Patient has no patent distal runoff vessels. * Patient has critical limb ischemia (i.e., Rutherford class 4-6) * Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s). * Interventional treatment is intended for in-stent restenosis. * Patient has target vessel with moderate or severe angulation (e.g., \>30 degrees) or tortuosity at the treatment segment. * Patient has a history of coagulopathy or hypercoagulable bleeding disorder. * Patient is receiving hemodialysis or has significantly impaired renal function (creatinine is \> 2.5 mg/dl) at the time of treatment. * Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months. * Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days. * Patient has had surgical or endovascular procedure in the same vascular territory within 30 days prior to the index procedure. * Patient has any planned surgical intervention or endovascular procedure within 30 days after the index procedure. * Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System will exclude the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binary Restenosis | 12 months | Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio \>2.5. Binary restenosis will be measured by duplex ultrasound technology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | Index Procedure | Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy |
| Ankle-Brachial Index (ABI) | 30 days | Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm. |
| Major Adverse Events (MAE) | 30 days | Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Jetstream Atherectomy System Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy | 241 |
| Total | 241 |
Baseline characteristics
| Characteristic | Jetstream Atherectomy System |
|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 241 participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 241 |
| serious Total, serious adverse events | 42 / 241 |
Outcome results
Primary
Binary Restenosis
Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio \>2.5. Binary restenosis will be measured by duplex ultrasound technology.
Time frame: 12 months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 184 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Jetstream Atherectomy System | Binary Restenosis | 22.8 percentage of patients |
Secondary
Ankle-Brachial Index (ABI)
Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
Time frame: 30 days
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Jetstream Atherectomy System | Ankle-Brachial Index (ABI) | 73.5 percentage of patients |
Secondary
Ankle-Brachial Index (ABI)
Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
Time frame: 6 months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 51 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Jetstream Atherectomy System | Ankle-Brachial Index (ABI) | 54.7 percentage of patients |
Secondary
Ankle-Brachial Index (ABI)
Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
Time frame: 12 months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 64 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Jetstream Atherectomy System | Ankle-Brachial Index (ABI) | 58.2 percentage of patients |
Secondary
Major Adverse Events (MAE)
Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days
Time frame: 30 days
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Jetstream Atherectomy System | Major Adverse Events (MAE) | 5 Major Adverse Events |
Secondary
Procedural Success
Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy
Time frame: Index Procedure
Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Jetstream Atherectomy System | Procedural Success | 98.3 percentage of patients |