The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis
To observe the treatment effects of the Auryon Laser Atherectomy System in treating Infrapopliteal peripheral arterial disease
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Palm Vascular Centers
Miami Beach, Florida, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
The Primary Safety Endpoint:
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
Time frame: 30 days
The Primary Performance Endpoint:
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.
Time frame: Index Procedure
Serious angiographic complications
flow-limiting dissection (D to F, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab
Time frame: Index Procedure
Technical success
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
Time frame: Index Procedure
Primary patency at 6 and 12 month
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
Time frame: 6 and 12 months
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Clinically Relevant Target Lesion Revascularization
(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)
Time frame: 12 months
Major Adverse Events (MAE)
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
Time frame: 30 days
Perforations
Perforations that require an intervention
Time frame: Index Procedure
Walking impairment questionnaire
reported as change from baseline
Time frame: 30 days, 3, 6, and 12 months
EQ-5D-5L Questionnaire
reported as change from baseline
Time frame: 30 days, 3, 6, and 12 months
Ankle-brachial Index (ABI) or Toe-brachial Index (TBI)
reported as change from baseline
Time frame: 30 days, 6 and 12 months
Rutherford Category
reported as change from baseline
Time frame: 30 days, 3, 6, and 12 months
Subgroup analysis stratified by IVUS
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
Time frame: Index Procedure
Healed Wounds
Number of healed wounds
Time frame: 30 days, 3, 6, and 12 months
Mean Lesion Diameter
IVUS subgroup: 20 patients. All will be evaluated for MLA pre and post laser and post final treatment.
Time frame: Index Procedure
Total Dissections
The presence and number of dissections will be classified based on iDissection classification
Time frame: Index Procedure