Treatment of Chronic Total Occlusions Using the Avinger Ocelot Crossing Catheter

Sewall, Luke E.

doi:10.1055/s-0035-1564703

Cited by 6 publications

(4 citation statements)

References 8 publications

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“…An important variable in the outcome of revascularization procedures is the type and extent of calcium in coronary and peripheral lesions since the incidence of revascularization and treatment success decreases as calcium burden in plaque increases [34][35][36]. Intravascular imaging to assess calcium in peripheral lesions provides information on the characteristics of calcium present in peripheral lesions as well as burden within the tissue [6,[37][38][39][40]. Use of either IVUS or OCT imaging to diagnose and guide treatment of calcified lesions in peripheral vessels has been associated with improved treatment outcomes since they either determine the appropriate path around such deposits or the appropriate treatment method to be used.…”

Section: Discussionmentioning

confidence: 99%

A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN)

Pavillard

Sewall

2020

BMC Med Imaging

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Background: Intravascular imaging plays an important part in diagnosis of vascular conditions and providing insight for treatment strategy. Two main imaging modalities are intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The objective of this study was to prove non-inferiority of OCT imaging to IVUS images in matched segments of peripheral vessels in patients with suspected peripheral vascular disease. Methods: The SCAN study was a prospective, non-inferiority clinical study of matched IVUS and OCT images collected along defined segments of peripheral vessels from twelve subjects (mean age 68 ± 10.3 years; 10 men) displaying symptoms of vascular disease. Luminal diameters were measured by both imaging systems at the distal, middle, and proximal points of the defined segments. Three blinded interventional radiologists evaluated the quality of both imaging modalities in identifying layered structures (3-point grading), plaque (5-point grading), calcification (5-point grading), stent structure (3-point grading), and artifacts (3-point grading) from 240 randomly ordered images. Mean grading scores and luminal diameters were calculated and analyzed with Student's t-Test and Mann-Whitney-Wilcoxon testing. Intrareader reproducibility was calculated by intraclass correlation (ICC) analysis. Results: The mean scoring of plaque, calcification, and vascular stent struts by the three readers was significant better in terms of image quality for OCT than IVUS (p < 0.001, p = 0.001, p = 0.004, respectively). The mean scores of vessel wall component visibility and artifacts generated by the two imaging systems were not significantly different (p = 0.19, p = 0.07, respectively). Mean vessel luminal diameter and area at three specific locations within the vessels were not significantly different between the two imaging modalities. No patient injury, adverse effect or device malfunction were noted during the study. Conclusions: Imaging by OCT provides the physician with better visualization of some vessel and plaque chacteristics, but both IVUS and OCT imaging are safe and effective methods of examining peripheral vessels in order to perform diagnostic assessment of peripheral vessels and provide information necessary for the treatment strategy of peripheral artery disease. Trial registration: NCT03480685 registered on 29 March 2018.

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Section: Discussionmentioning

confidence: 99%

A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN)

Pavillard

Sewall

2020

BMC Med Imaging

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“…Nonetheless, long SFA CTO was actually classified as TASC D, which should be treated with the open surgical procedure rather than endovascular [9]. The OCT Guided Ocelot Catheter is designed for chronic total SFA occlusion revascularization and 10 mm image resolution allows differentiation between various healthy arterial structures including media and adventitia, and diseased arterial walls including atherosclerotic plaque [10]. The high resolution visual guidance would minimize media injury which could yield better long-term outcomes and patency [11].…”

Section: Discussionmentioning

confidence: 99%

Five-year outcomes after revascularization of superficial femoral artery occlusion using Ocelot catheter

Nowakowski

Buszman

Janas³

et al. 2019

pwki

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Introduction: The population of patients with lower limb atherosclerosis includes a considerable proportion of individuals with long superficial femoral artery (SFA) lesions. Chronic total occlusions (CTOs) represent the "last frontier" of percutaneous interventions. While open strategies are considered earlier as standard management for these lesions, the results of a number of trials indicate that endovascular management might become an effective alternative to surgery. Material and methods: This paper presents 5-year outcomes of a first-in-man (FIM) study (before CE mark) and the registry of OCT Guided Ocelot Catheter (Avinger) for chronic total occlusions of the superficial femoral artery. The study group comprised 10 patients with Rutherford 3 lower limb ischemia including nine men and one woman. Results: The efficacy of the primary intervention was 90%. Angiography performed at 6 months of the procedure, according to the study protocol, revealed 3 and 1 cases of restenosis and reocclusion, respectively, repaired using PTA and open common and deep femoral artery patch plasty. Doppler ultrasound performed at 1, 2 and 5 years after the primary intervention did not reveal significant target vessel restenosis. The primary and primary-assisted patency was 89%. During a 5-year follow-up, four peripheral percutaneous interventions and one femoropopliteal bypass surgery were performed in non-target limbs. There were no cardiovascular deaths, myocardial infarction or stroke and no amputation was required. Conclusions: This is a first-in-man study reporting long-term follow-up after SFA CTO revascularization using the Ocelot catheter. The catheter proved to have a satisfactory safety profile and a high proportion of CTO crossings. A 5-year follow-up revealed high primary and primary-assisted patency rates.

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“…Compared to a primary wire‐catheter crossing strategy, CTO crossing devices are associated with a higher primary technical success rate and a lower risk of revascularization over 1‐year of follow‐up 3 . While previous studies have reported results obtained with various dedicated CTO crossing devices, 4‐8 each employ different mechanisms by which CTO crossing is achieved. Thus, the efficacy and safety of these catheters may be device‐specific and clinical studies with new CTO crossing catheters are warranted.…”

Section: Introductionmentioning

confidence: 99%

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short‐term results from the international Wing‐It trial

Laird

Mathews

Brodmann

et al. 2020

Cathet Cardio Intervent

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Objectives To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires. Background CTO crossing remains a challenge during peripheral artery interventions. Methods In this prospective, international, single‐arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30‐day follow‐up period and compared to a performance goal of 13.0%. Results A total of 85 patients were treated using the Wingman catheter for peripheral artery CTO crossing. Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14%). Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%). Over 30 days of follow‐up, Rutherford score decreased by at least 2 categories in 74% patients; the percentage of patients with normal hemodynamics assessed with the ankle‐brachial index increased from 1% to 51%. Conclusions Among patients with a CTO that was unable to be crossed with a standard guidewire, the Wingman catheter was able to cross 90% of occlusions with a favorable safety profile.

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Treatment of Chronic Total Occlusions Using the Avinger Ocelot Crossing Catheter

Cited by 6 publications

References 8 publications

A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN)

A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN)

Five-year outcomes after revascularization of superficial femoral artery occlusion using Ocelot catheter

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short‐term results from the international Wing‐It trial

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