Peripheral Arterial Disease
Conditions
Brief summary
The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis
Detailed description
To observe the treatment effects of the Auryon Laser Atherectomy System in treating Infrapopliteal peripheral arterial disease
Interventions
DEVICEAuryon Laser System
The Auryon BTK Study is a prospective, single arm multicenter study evaluating the safety and procedural effectiveness of the Auryon laser in treating infrapopliteal disease in patients with critical limb ischemia and claudication. The primary exposure of interest for this study is the use of the AURYON system for atherectomy.
Sponsors
Angiodynamics, Inc.
Midwest Cardiovascular Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter, single arm study Patients with symptomatic peripheral vascular disease who underwent infrapopliteal percutaneous intervention using the Auryon laser system 4 sites in United States
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1\. Subject is 18 years of age or older. 2. Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure. 3\. Patient has signed approved informed consent. 4. Patient is willing to comply with the follow-up evaluations Angiographic Inclusion Criteria 1. Target lesions(s) must be viewed angiographically and have ≥50% stenosis. More than one lesion can be included in the same vessel. 2. Only 1 target vessel is included in the study. 3. Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion. Target Lesion reference vessel diameter (RVD) between 1.5 mm - 4.5 mm. by investigator estimate. 4\. Target lesion is denovo or restenotic. \-
Exclusion criteria
1. Target lesion is in a vessel graft or synthetic graft. 2. Subjects requiring dialysis. 3. Subject is unable to understand the study or has a history of non-compliance with medical advice. 4. Subject is unwilling or unable to sign the Informed Consent Form (ICF) 5. Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints. 6. Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for. 7. Subject has a CVA or TIA within 4 weeks prior to the Auryon procedure. 8. Planned Use of another debulking device or specialty balloons before or after the Auryon laser during the index procedure 9. Patient has any planned surgical intervention or endovascular procedure ≤14 days after the index procedure or had these procedures in the past 14 days 10. Life expectancy of less than one year judged by the investigator 11. Patient unable to take anticoagulant or antiplatelet agents 12. Platelet count less than 80,000K or bleeding disorders 13. Subject is suspected of having an active systemic infection. 14. Patient enrolled once already in the protocol 15. Planned major amputation of either leg. 16. Acute limb ischemia 17. Current Covid-19 Infection or history of Covid-19 in the past 30 days. 18. Subject is pregnant or planning on becoming pregnant. 19. Vulnerable patients who are unable to give informed consent on their own Pregnant and Vulnerable Populations. There will be no female patients who are pregnant or any vulnerable populations enrolled in the study. 20. Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure 21. Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Safety Endpoint: | 30 days | Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days, as adjudicated by the CEC, defined as a composite of: 1. All-cause death 2. Above-ankle amputation of the index limb 3. Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery |
| The Primary Performance Endpoint: | Index Procedure | Procedure Success defined as ≤30% residual stenosis for the treated segment of the vessel without serious angiographic complications (flow-limiting dissection (D to F), perforation, distal embolization, or acute vessel closure after final treatment, as assessed by the angiographic core lab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious angiographic complications | Index Procedure | flow-limiting dissection (D to F, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab |
| Technical success | Index Procedure | defined as residual stenosis ≤50% in the target lesion after Auryon laser and prior to adjunctive balloon treatment without significant angiographic complications, as assessed by the angiographic core lab |
| Primary patency at 6 and 12 month | 6 and 12 months | s defined as the absence of both total occlusion (100% diameter stenosis by DUS) in all of the target lesions, as well as a Clinically-Driven Target Lesion Revascularization (CD-TLR) (definition in D below). An alternative patency analysis will be done with patency defined as the presence of significant restenosis at the treated site using PSVR of ≤ 2.4 as the threshold for patency and absence of CD-TLR |
| Clinically Relevant Target Lesion Revascularization | 12 months | (CD-TLR) at 30 days, 3, 6, and 12 months defined as recurrence of symptoms (worsening by one Rutherford Becker Category from post index procedure) with an objective evidence of obstructive disease (occlusion or PSVR \> 2.4 by DUS; or ABI change by 0.15 from post procedure ABI) |
| Walking impairment questionnaire | 30 days, 3, 6, and 12 months | reported as change from baseline |
| EQ-5D-5L Questionnaire | 30 days, 3, 6, and 12 months | reported as change from baseline |
| Major Adverse Events (MAE) | 30 days | Composite * Need for emergency surgical revascularization of target limb * Unplanned target limb major amputation (above the ankle) * Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow, and extend hospitalization |
| Rutherford Category | 30 days, 3, 6, and 12 months | reported as change from baseline |
| Subgroup analysis stratified by IVUS | Index Procedure | Subgroup analysis stratified by IVUS vs non IVUS patients for the primary performance endpoint and the following secondary endpoints: Final Balloon Size used to dilate lesion post laser, CD-target lesion revascularization and clinical patency |
| Healed Wounds | 30 days, 3, 6, and 12 months | Number of healed wounds |
| Mean Lesion Diameter | Index Procedure | IVUS subgroup: 20 patients. All will be evaluated for MLA pre and post laser and post final treatment. |
| Total Dissections | Index Procedure | The presence and number of dissections will be classified based on iDissection classification |
| Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) | 30 days, 6 and 12 months | reported as change from baseline |
| Perforations | Index Procedure | Perforations that require an intervention |
Countries
United States
Outcome results
None listed