Peripheral Arterial Disease
Conditions
Brief summary
A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.
Detailed description
This is a prospective, global, single-arm, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy of in-stent restenotic (ISR) lesions in lower extremity arteries. The trial will enroll up to 140 subjects diagnosed with peripheral arterial disease of the lower extremities that have previously been treated with stenting at up to 20 sites. The primary disease must be located in reference vessel diameter of \>3.0mm and ≤7.0mm. Trial success is focused on safety, including rates of major adverse events through 30 days as adjudicated by a Clinical Events Committee, and effectiveness, which will be evaluated using technical success defined as the percent of target lesions that have residual diameter stenosis \<50% post-treatment with the Pantheris device alone as assessed by Angiographic Core Lab.
Interventions
DEVICEAtherectomy Catheter
Treatment of restenotic lesions within stents previously placed within the artery.
Sponsors
Avinger, Inc.
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
* Subject is \>18 years old; * Subject is willing and able to give informed consent; * Subject has Rutherford Classification of I-V; * Subject presenting with a single Class I, II or III ISR lesion as per Tosaka's Classification criteria in the lower leg extremities; * Target lesion must be \>70% stenosed and within a stented segment by angiographic visual estimation; * Reference vessel lumen acceptable for treatment with Pantheris catheter size as per visual angiographic estimation; * Target lesions must be within the stented segment and no more than 3 cm past the proximal or distal portions of the stent; * Target lesion is ≤30 cm in length; * Intraluminal crossing of totally occluded lesions prior to atherectomy; * At least one patent tibial run-off vessel at baseline; and * Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days, 6 months and 12 months.
Exclusion criteria
* Subject is pregnant or breast feeding; * Rutherford Class 0 or VI; * Severe calcification of the target lesion; * Acute ischemia and/or acute thrombosis of the target lesion segment; * Target lesion with a covered stent; * Target lesion in the iliac artery; * Target lesion stenosis \<70%; * Target lesion \>30 cm in length; * Subjects with totally occluded stented segments that are not successfully crossed intraluminally prior to atherectomy treatment; * Grade 4 or 5 stent fracture affecting target stent, or where evidence of stent protrusion into the lumen is noted on angiography in two orthogonal views; * Subjects on chronic hemodialysis or creatinine level \>2.5 mg/dL; * CVA or stroke within 60 days prior to the index procedure; * Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure; * Planned endovascular or surgical procedure 30 days after the index procedure; * Lesion in the contralateral limb requiring intervention during the index * procedure or within 30 days of the index procedure; * Known allergy to contrast agents or medications used to perform endovascular * intervention that cannot be adequately pre-treated; * Subjects in whom anti-platelet, aspirin, anticoagulant, or thrombolytic therapy is contraindicated; * Any thrombolytic therapy within 2 weeks of the index procedure; * Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject during the index procedure; * Subjects or their legal guardians who have not or will not sign the Informed Consent; * Subjects who are unwilling or unable to comply with the follow-up study * requirements; or * Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from a composite of major adverse events (MAEs) through 30-day follow-up (safety) | Day 0 through 30 days post treatment procedure | The primary safety endpoint is freedom from a composite of major adverse events (MAEs) through 30-day follow-up, as adjudicated by an independent CEC. Individual MAEs include: 1. Cardiovascular-related death; 2. Unplanned, major index limb amputation; 3. Clinically driven target lesion revascularization (TLR); 4. Myocardial infarction; or 5. Device-associated events: 1. Clinically significant perforation, 2. Clinically significant dissection, 3. Clinically significant embolus, or 4. Pseudoaneurysm. |
| Technical success of Pantheris catheter treatment (efficacy) device | Day 0 | The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis \<50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoint - Procedural Success | Day 0 | Procedural success defined as the percent of target lesions that have residual diameter stenosis ≤ 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory. |
| Secondary Effectiveness Endpoint - Ankle-Brachial Index | 30 days, 6 and 12 months post treatment procedure | Ankle-Brachial Index at 30 days, 6 and 12 months |
| Stent structure freedom from new or worsening stent fracture post Pantheris treatment (safety) | Day 0 | Assess the stent for new or worsening stent fracture per comparative Pantheris OCT evaluation pre- and immediately post-procedure. |
| Secondary Effectiveness Endpoint - Use Adjunctive Devices | Day 0 | Adjunctive devices (stent placement (bare metal or drug eluting stent), drug eluting balloon or other) utilized during the index procedure. |
| Secondary Effectiveness Endpoint - Rutherford Classification | 30 days, 6 and 12 months post treatment procedure | Rutherford Classification at 30 days, 6 and 12 months |
| Secondary Effectiveness Endpoint - Freedom from TLR | 6 months post treatment procedure | Freedom from TLR at 6 months as assessed by an independent CEC. |
Countries
United States
Outcome results
None listed