Peripheral Vascular Disease, Restenosis
Conditions
Keywords
Restenosis, aspiration, in-stent restenosis, atherectomy, superficial femoral artery, popliteal artery
Brief summary
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.
Detailed description
Data not available yet.
Interventions
DEVICEJetStream Navitus
Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.
Sponsors
MEDRAD, Inc.
Midwest Cardiovascular Research Foundation
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
1. Subject is 18 years of age or older. 2. Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal) 3. Subject presents with a Rutherford Classification of 1-5 and has symptoms of rest limb pain, ulcerations or claudication. 4. Target lesion(s) must be viewed angiographically and have ≥50% stenosis. 5. The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage. 6. The main target vessel reference diameter must be at least 5 mm. 7. One patent distal run-off vessel with brisk flow is required. 8. Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled instructions for use. 9. Patient has signed approved informed consent. 10. Patient is willing to comply with the follow-up evaluations at specified times.
Exclusion criteria
1. Subject is unable to understand the study or has a history of non-compliance with medical advice. 2. Subject is unwilling or unable to sign the Informed Consent Form (ICF). 3. Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints (e.g., limit use of study-recommended medications, etc.). 4. Subject is pregnant or planning to become pregnant within the study period. 5. Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for. 6. Subject is diagnosed with chronic renal failure or has a creatinine level \> 2.5 mg/dl and is not on chronic dialysis. 7. Subject has a known allergy to heparin, ASA, Plavix. 8. Subject has a history of bleeding disorders or platelet count \< 80,000 cells/ml. 9. Subject experiences ongoing cardiac problems (e.g., cardiac arrhythmias, congestive heart failure exacerbation, myocardial infarction, etc.) that, per the investigator, would not make the subject an ideal candidate for study procedures. 10. Subject has a CVA or TIA within 4 weeks prior to JetStream procedure. 11. Subject has an anticipated life span of less than 6 months. 12. Subject is suspected of having an active systemic infection. 13. Subject per the investigator's medical judgment must be excluded from the study. 14. Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s). 15. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months. 16. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days. 17. Patient has any planned surgical intervention or endovascular procedure within 15 days after the index procedure. 18. Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System. 19. Use of another debulking device after the Jetstream NAVITUS system. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Procedural Success | intraprocedural | Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patency | 6 months | Patency is defined as Peak Systolic Velocity Ratio (PSVR) of \< 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion. |
| Target Lesion Revascularization | 6 months | Reintervention on the same index lesion at 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acute Device Success | intraprocedural | Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events. |
Countries
United States
Participant flow
Recruitment details
29 patients with FP ISR in 32 limbs were treated at 2 medical centers by 2 operators from October 2012 to August 2014. Patients were eligible only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5, and at least one patent runoff vessel.
Pre-assignment details
Patients were excluded if they were not able to give informed consent, had a creatinine level \>2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure. After consenting, patient were excluded if had denovo disease or no in-stent restenosis in the target vessel.
Participants by arm
| Arm | Count |
|---|---|
| JetStream Atherectomy Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery. Patients were eligible for the study only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5 ischemia, and at least one patent infrapopliteal runoff vessel. Patients were excluded if they were not able to give informed consent, had a creatinine level \>2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure.The JetStream was used as a first modality of treatment, no other debulking devices, cutting/scoring balloons, or cryogenic balloons were allowed. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | JetStream Atherectomy | — |
|---|---|---|
| Age, Continuous | 69.9 years STANDARD_DEVIATION 11.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 29 Participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 29 |
| other Total, other adverse events | 3 / 29 |
| serious Total, serious adverse events | 4 / 29 |
Outcome results
Primary
Acute Procedural Success
Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.
Time frame: intraprocedural
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| JetStream Atherectomy | Acute Procedural Success | 29 limbs |
Secondary
Patency
Patency is defined as Peak Systolic Velocity Ratio (PSVR) of \< 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.
Time frame: 6 months
Population: Only 25 limbs had duplex ultrasound at 6 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JetStream Atherectomy | Patency | 72 Percentage of patent limbs |
Secondary
Target Lesion Revascularization
Reintervention on the same index lesion at 6 months
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| JetStream Atherectomy | Target Lesion Revascularization | 4 lesions |
Other Pre-specified
Acute Device Success
Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.
Time frame: intraprocedural
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| JetStream Atherectomy | Acute Device Success | 22 limbs |